Trial Outcomes & Findings for Acute Intermittent Hypoxia and Breathing in Neuromuscular Disease (NCT NCT03645031)
NCT ID: NCT03645031
Last Updated: 2025-05-15
Results Overview
MIP is a maximal voluntary static contraction of the inspiratory muscles against a closed valve, measured at the mouth. The test will be repeated until 3 measurements are obtained within 10% variability and an average of the three trials is reported. The change in MIP will be the percent difference in pressure between the averaged baseline MIP and the averaged follow-up measure, which is tested 60 minutes after the gas intervention.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
29 participants
Primary outcome timeframe
3 Hours
Results posted on
2025-05-15
Participant Flow
Participant milestones
| Measure |
ALS Group - AIH Followed by Sham
Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH) as well as, the 45 minute sham AIH session, consisting of breathing air with normal oxygen levels two weeks later. Breathing, muscle activity and heart activity will be monitored before, during and after both procedures.
Acute Intermittent Hypoxia: AIH entails continuous breathing as the level of oxygen in the air is decreased, then returned to normal. Participants will alternate between breathing normal air and breathing hypoxic air (air that has less oxygen). Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH). Breathing, muscle activity and heart activity will be monitored before, during and after the procedure. The intervals will last 1 minute each.
Sham Acute Intermittent Hypoxia: Participants will complete the sham acute intermittent hypoxia, consisting of a single 45 minute session of breathing air with normal oxygen levels. All aspects of this procedure will otherwise be the same as for the AIH procedure. Breathing, muscle activity and heart activity will be monitored before, during and after the procedure.
|
Healthy Control Group - AIH Followed by Sham Hypoxia
Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH) as well as, the 45 minute sham AIH session, consisting of breathing air with normal oxygen levels two weeks later. Breathing, muscle activity and heart activity will be monitored before, during and after both procedures.
Acute Intermittent Hypoxia: AIH entails continuous breathing as the level of oxygen in the air is decreased, then returned to normal. Participants will alternate between breathing normal air and breathing hypoxic air (air that has less oxygen). Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH). Breathing, muscle activity and heart activity will be monitored before, during and after the procedure. The intervals will last 1 minute each.
Sham Acute Intermittent Hypoxia: Participants will complete the sham acute intermittent hypoxia, consisting of a single 45 minute session of breathing air with normal oxygen levels. All aspects of this procedure will otherwise be the same as for the AIH procedure. Breathing, muscle activity and heart activity will be monitored before, during and after the procedure.
|
ALS Group, Sham Followed by AIH
Participants will complete a single 45 minute session of sham intermittent hypoxia consisting of breathing air with normal oxygen levels, as well as a single 45 minute session of acute intermittent hypoxia (AIH) two weeks later. Breathing, muscle activity and heart activity will be monitored before, during and after both procedures.
|
Healthy Control Group, Sham Followed by AIH
Participants will complete a single 45 minute session of sham intermittent hypoxia consisting of breathing air with normal oxygen levels, as well as a single 45 minute session of acute intermittent hypoxia (AIH) two weeks later. Breathing, muscle activity and heart activity will be monitored before, during and after both procedures.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
8
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
8
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The healthy controls do not have an ALS-FRS score.
Baseline characteristics by cohort
| Measure |
ALS Group
n=13 Participants
Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH), as well as, the 45 minute sham AIH session, consisting of breathing air with normal oxygen levels. Breathing, muscle activity and heart activity will be monitored before, during and after both procedures.
Acute Intermittent Hypoxia: AIH entails continuous breathing as the level of oxygen in the air is decreased, then returned to normal. Participants will alternate between breathing normal air and breathing hypoxic air (air that has less oxygen). Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH). Breathing, muscle activity and heart activity will be monitored before, during and after the procedure. The intervals will last 1 minute each.
Sham Acute Intermittent Hypoxia: Participants will complete the sham acute intermittent hypoxia, consisting of a single 45 minute session of breathing air with normal oxygen levels. All aspects of this procedure will otherwise be the same as for the AIH procedure. Breathing, muscle activity and heart activity will be monitored before, during and after the procedure.
|
Healthy Control Group
n=10 Participants
Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH), as well as, the 45 minute sham AIH session, consisting of breathing air with normal oxygen levels. Breathing, muscle activity and heart activity will be monitored before, during and after both procedures.
Acute Intermittent Hypoxia: AIH entails continuous breathing as the level of oxygen in the air is decreased, then returned to normal. Participants will alternate between breathing normal air and breathing hypoxic air (air that has less oxygen). Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH). Breathing, muscle activity and heart activity will be monitored before, during and after the procedure. The intervals will last 1 minute each.
Sham Acute Intermittent Hypoxia: Participants will complete the sham acute intermittent hypoxia, consisting of a single 45 minute session of breathing air with normal oxygen levels. All aspects of this procedure will otherwise be the same as for the AIH procedure. Breathing, muscle activity and heart activity will be monitored before, during and after the procedure.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=13 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=23 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=13 Participants
|
3 Participants
n=10 Participants
|
9 Participants
n=23 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=13 Participants
|
7 Participants
n=10 Participants
|
14 Participants
n=23 Participants
|
|
Age, Continuous
|
65.3 years
n=13 Participants
|
67.4 years
n=10 Participants
|
66.2 years
n=23 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=13 Participants
|
4 Participants
n=10 Participants
|
7 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=13 Participants
|
6 Participants
n=10 Participants
|
16 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=13 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=13 Participants
|
10 Participants
n=10 Participants
|
21 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=13 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=13 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=13 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=13 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=13 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=13 Participants
|
8 Participants
n=10 Participants
|
21 Participants
n=23 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=13 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=13 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=23 Participants
|
|
Region of Enrollment
United States
|
13 Participants
n=13 Participants
|
10 Participants
n=10 Participants
|
23 Participants
n=23 Participants
|
|
Vital capacity (% predicted)
|
83.3 Percentage
n=13 Participants
|
105.2 Percentage
n=10 Participants
|
92.8 Percentage
n=23 Participants
|
|
Amyotrophic Lateral Sclerosis Functional Rating Scale- Revised (ALS-RFS-R)
|
38.8 units on a scale
n=13 Participants • The healthy controls do not have an ALS-FRS score.
|
—
|
38.8 units on a scale
n=13 Participants • The healthy controls do not have an ALS-FRS score.
|
PRIMARY outcome
Timeframe: 3 HoursPopulation: Individuals with an ALS diagnosis and age matched healthy controls.
MIP is a maximal voluntary static contraction of the inspiratory muscles against a closed valve, measured at the mouth. The test will be repeated until 3 measurements are obtained within 10% variability and an average of the three trials is reported. The change in MIP will be the percent difference in pressure between the averaged baseline MIP and the averaged follow-up measure, which is tested 60 minutes after the gas intervention.
Outcome measures
| Measure |
ALS Group
n=13 Participants
Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH), as well as, the 45 minute sham AIH session, consisting of breathing air with normal oxygen levels. Breathing, muscle activity and heart activity will be monitored before, during and after both procedures.
Acute Intermittent Hypoxia: AIH entails continuous breathing as the level of oxygen in the air is decreased, then returned to normal. Participants will alternate between breathing normal air and breathing hypoxic air (air that has less oxygen). Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH). Breathing, muscle activity and heart activity will be monitored before, during and after the procedure. The intervals will last 1 minute each.
Sham Acute Intermittent Hypoxia: Participants will complete the sham acute intermittent hypoxia, consisting of a single 45 minute session of breathing air with normal oxygen levels. All aspects of this procedure will otherwise be the same as for the AIH procedure. Breathing, muscle activity and heart activity will be monitored before, during and after the procedure.
|
Healthy Control Group
n=10 Participants
Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH), as well as, the 45 minute sham AIH session, consisting of breathing air with normal oxygen levels. Breathing, muscle activity and heart activity will be monitored before, during and after both procedures.
Acute Intermittent Hypoxia: AIH entails continuous breathing as the level of oxygen in the air is decreased, then returned to normal. Participants will alternate between breathing normal air and breathing hypoxic air (air that has less oxygen). Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH). Breathing, muscle activity and heart activity will be monitored before, during and after the procedure. The intervals will last 1 minute each.
Sham Acute Intermittent Hypoxia: Participants will complete the sham acute intermittent hypoxia, consisting of a single 45 minute session of breathing air with normal oxygen levels. All aspects of this procedure will otherwise be the same as for the AIH procedure. Breathing, muscle activity and heart activity will be monitored before, during and after the procedure.
|
ALS Group - Sham Hypoxia
People diagnosed with ALS, underwent a single 45 minute session of acute intermittent hypoxia (AIH), which entails alternating between breathing normal air and breathing sham hypoxia, which is also normal air. Participants completed a single 45 minute session of sham hypoxia.
|
Control Group
Unaffected control participants underwent a single 45 minute session of acute intermittent hypoxia (AIH), which entails alternating between breathing normal air and breathing sham hypoxia, which is also normal air. Participants completed a single 45 minute session of sham hypoxia.
|
|---|---|---|---|---|
|
Percent Change in Maximal Inspiratory Pressure (MIP)
Sham Hypoxia
|
0.3 percentage change in MIP from baseline
Standard Error 2.9
|
-3.1 percentage change in MIP from baseline
Standard Error 2.3
|
—
|
—
|
|
Percent Change in Maximal Inspiratory Pressure (MIP)
AIH
|
-4.8 percentage change in MIP from baseline
Standard Error 1.6
|
-5.0 percentage change in MIP from baseline
Standard Error 3.2
|
—
|
—
|
PRIMARY outcome
Timeframe: 3 HoursPopulation: Individuals with an ALS diagnosis and age matched unaffected controls.
Maximal static voluntary handgrip contractions will be evaluated in a seated position with the arm at the side and elbow flexed to 90 degrees. The test will be repeated until 3 measurements are obtained within 10% variability and then averaged. The change in grip will be the percent difference in force between the averaged baseline grip and the averaged follow-up grip measure, which is tested 60 minutes after the gas intervention.
Outcome measures
| Measure |
ALS Group
n=13 Participants
Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH), as well as, the 45 minute sham AIH session, consisting of breathing air with normal oxygen levels. Breathing, muscle activity and heart activity will be monitored before, during and after both procedures.
Acute Intermittent Hypoxia: AIH entails continuous breathing as the level of oxygen in the air is decreased, then returned to normal. Participants will alternate between breathing normal air and breathing hypoxic air (air that has less oxygen). Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH). Breathing, muscle activity and heart activity will be monitored before, during and after the procedure. The intervals will last 1 minute each.
Sham Acute Intermittent Hypoxia: Participants will complete the sham acute intermittent hypoxia, consisting of a single 45 minute session of breathing air with normal oxygen levels. All aspects of this procedure will otherwise be the same as for the AIH procedure. Breathing, muscle activity and heart activity will be monitored before, during and after the procedure.
|
Healthy Control Group
n=10 Participants
Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH), as well as, the 45 minute sham AIH session, consisting of breathing air with normal oxygen levels. Breathing, muscle activity and heart activity will be monitored before, during and after both procedures.
Acute Intermittent Hypoxia: AIH entails continuous breathing as the level of oxygen in the air is decreased, then returned to normal. Participants will alternate between breathing normal air and breathing hypoxic air (air that has less oxygen). Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH). Breathing, muscle activity and heart activity will be monitored before, during and after the procedure. The intervals will last 1 minute each.
Sham Acute Intermittent Hypoxia: Participants will complete the sham acute intermittent hypoxia, consisting of a single 45 minute session of breathing air with normal oxygen levels. All aspects of this procedure will otherwise be the same as for the AIH procedure. Breathing, muscle activity and heart activity will be monitored before, during and after the procedure.
|
ALS Group - Sham Hypoxia
People diagnosed with ALS, underwent a single 45 minute session of acute intermittent hypoxia (AIH), which entails alternating between breathing normal air and breathing sham hypoxia, which is also normal air. Participants completed a single 45 minute session of sham hypoxia.
|
Control Group
Unaffected control participants underwent a single 45 minute session of acute intermittent hypoxia (AIH), which entails alternating between breathing normal air and breathing sham hypoxia, which is also normal air. Participants completed a single 45 minute session of sham hypoxia.
|
|---|---|---|---|---|
|
Percent Change in Maximal Voluntary Grip Force
AIH
|
-8.2 percent change in grip forcfrom baseline
Standard Error 0.26
|
-11.2 percent change in grip forcfrom baseline
Standard Error 0.24
|
—
|
—
|
|
Percent Change in Maximal Voluntary Grip Force
SHAM
|
14.5 percent change in grip forcfrom baseline
Standard Error 0.11
|
18.2 percent change in grip forcfrom baseline
Standard Error 0.07
|
—
|
—
|
PRIMARY outcome
Timeframe: 3 HoursPopulation: Individuals with an ALS diagnosis and age matched healthy controls.
Maximal voluntary contractions of the inspiratory muscles measured with a pressure sensor placed in the nare. The test will be repeated until 3 measurements are obtained within 10% variability and then averaged. The change in sniff nasal inspiratory pressure will be the percent difference in pressure between the averaged baseline sniff nasal inspiratory pressure and the averaged follow-up measure, which is tested 60 minutes after the gas intervention.
Outcome measures
| Measure |
ALS Group
n=13 Participants
Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH), as well as, the 45 minute sham AIH session, consisting of breathing air with normal oxygen levels. Breathing, muscle activity and heart activity will be monitored before, during and after both procedures.
Acute Intermittent Hypoxia: AIH entails continuous breathing as the level of oxygen in the air is decreased, then returned to normal. Participants will alternate between breathing normal air and breathing hypoxic air (air that has less oxygen). Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH). Breathing, muscle activity and heart activity will be monitored before, during and after the procedure. The intervals will last 1 minute each.
Sham Acute Intermittent Hypoxia: Participants will complete the sham acute intermittent hypoxia, consisting of a single 45 minute session of breathing air with normal oxygen levels. All aspects of this procedure will otherwise be the same as for the AIH procedure. Breathing, muscle activity and heart activity will be monitored before, during and after the procedure.
|
Healthy Control Group
n=10 Participants
Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH), as well as, the 45 minute sham AIH session, consisting of breathing air with normal oxygen levels. Breathing, muscle activity and heart activity will be monitored before, during and after both procedures.
Acute Intermittent Hypoxia: AIH entails continuous breathing as the level of oxygen in the air is decreased, then returned to normal. Participants will alternate between breathing normal air and breathing hypoxic air (air that has less oxygen). Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH). Breathing, muscle activity and heart activity will be monitored before, during and after the procedure. The intervals will last 1 minute each.
Sham Acute Intermittent Hypoxia: Participants will complete the sham acute intermittent hypoxia, consisting of a single 45 minute session of breathing air with normal oxygen levels. All aspects of this procedure will otherwise be the same as for the AIH procedure. Breathing, muscle activity and heart activity will be monitored before, during and after the procedure.
|
ALS Group - Sham Hypoxia
People diagnosed with ALS, underwent a single 45 minute session of acute intermittent hypoxia (AIH), which entails alternating between breathing normal air and breathing sham hypoxia, which is also normal air. Participants completed a single 45 minute session of sham hypoxia.
|
Control Group
Unaffected control participants underwent a single 45 minute session of acute intermittent hypoxia (AIH), which entails alternating between breathing normal air and breathing sham hypoxia, which is also normal air. Participants completed a single 45 minute session of sham hypoxia.
|
|---|---|---|---|---|
|
Percent Change in Sniff Nasal Inspiratory Pressure
Sham
|
2.5 Percent Change from Baseline
Standard Deviation 4.1
|
7.4 Percent Change from Baseline
Standard Deviation 5.9
|
—
|
—
|
|
Percent Change in Sniff Nasal Inspiratory Pressure
AIH
|
4.9 Percent Change from Baseline
Standard Deviation 5.0
|
5.8 Percent Change from Baseline
Standard Deviation 5.5
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 HoursPopulation: Individuals with an ALS diagnosis and age matched controls.
Minute ventilation is measured using a pneumotachograph connected to the face mask to record breath-by-breath volume and breathing rate, which is then multiplied to calculate minute ventilation. After achieving a stable tidal volume, 5 minutes of resting minute ventilation will be recorded and then averaged. The change in minute ventilation will be the percent difference in volume between the averaged baseline ventilation and the averaged follow-up ventilation, which is tested 60 minutes after the gas intervention.
Outcome measures
| Measure |
ALS Group
n=13 Participants
Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH), as well as, the 45 minute sham AIH session, consisting of breathing air with normal oxygen levels. Breathing, muscle activity and heart activity will be monitored before, during and after both procedures.
Acute Intermittent Hypoxia: AIH entails continuous breathing as the level of oxygen in the air is decreased, then returned to normal. Participants will alternate between breathing normal air and breathing hypoxic air (air that has less oxygen). Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH). Breathing, muscle activity and heart activity will be monitored before, during and after the procedure. The intervals will last 1 minute each.
Sham Acute Intermittent Hypoxia: Participants will complete the sham acute intermittent hypoxia, consisting of a single 45 minute session of breathing air with normal oxygen levels. All aspects of this procedure will otherwise be the same as for the AIH procedure. Breathing, muscle activity and heart activity will be monitored before, during and after the procedure.
|
Healthy Control Group
n=10 Participants
Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH), as well as, the 45 minute sham AIH session, consisting of breathing air with normal oxygen levels. Breathing, muscle activity and heart activity will be monitored before, during and after both procedures.
Acute Intermittent Hypoxia: AIH entails continuous breathing as the level of oxygen in the air is decreased, then returned to normal. Participants will alternate between breathing normal air and breathing hypoxic air (air that has less oxygen). Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH). Breathing, muscle activity and heart activity will be monitored before, during and after the procedure. The intervals will last 1 minute each.
Sham Acute Intermittent Hypoxia: Participants will complete the sham acute intermittent hypoxia, consisting of a single 45 minute session of breathing air with normal oxygen levels. All aspects of this procedure will otherwise be the same as for the AIH procedure. Breathing, muscle activity and heart activity will be monitored before, during and after the procedure.
|
ALS Group - Sham Hypoxia
People diagnosed with ALS, underwent a single 45 minute session of acute intermittent hypoxia (AIH), which entails alternating between breathing normal air and breathing sham hypoxia, which is also normal air. Participants completed a single 45 minute session of sham hypoxia.
|
Control Group
Unaffected control participants underwent a single 45 minute session of acute intermittent hypoxia (AIH), which entails alternating between breathing normal air and breathing sham hypoxia, which is also normal air. Participants completed a single 45 minute session of sham hypoxia.
|
|---|---|---|---|---|
|
Percent Change in Minute Ventilation
Sham hypoxia
|
5.7 percentage change from baseline
Standard Error 7.3
|
-5.6 percentage change from baseline
Standard Error 5.4
|
—
|
—
|
|
Percent Change in Minute Ventilation
AIH
|
19.5 percentage change from baseline
Standard Error 6.0
|
2.6 percentage change from baseline
Standard Error 7.2
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 HoursPopulation: Individuals with an ALS diagnosis and age matched healthy controls who completed a single exposure to acute intermittent hypoxia. P0.1 during sham hypoxia presentations were not collected due to an oversight by study staff and cannot be reported.
P0.1 is measured with a pressure transducer connected to a face mask and represents the pressure generated against a transiently occluded airway in the first 0.1 sec of inspiration. The generated during this initial period of inspiration is resistant to learning or sensory bias and is considered a clinical estimate of inspiratory drive. Five measurements will be conducted and then averaged, with 5-15 un-occluded breaths between each P0.1 measurement. The averaged pressures at baseline and 60 minutes post-gas intervention will be reported and will be expressed in cm H2O.
Outcome measures
| Measure |
ALS Group
n=9 Participants
Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH), as well as, the 45 minute sham AIH session, consisting of breathing air with normal oxygen levels. Breathing, muscle activity and heart activity will be monitored before, during and after both procedures.
Acute Intermittent Hypoxia: AIH entails continuous breathing as the level of oxygen in the air is decreased, then returned to normal. Participants will alternate between breathing normal air and breathing hypoxic air (air that has less oxygen). Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH). Breathing, muscle activity and heart activity will be monitored before, during and after the procedure. The intervals will last 1 minute each.
Sham Acute Intermittent Hypoxia: Participants will complete the sham acute intermittent hypoxia, consisting of a single 45 minute session of breathing air with normal oxygen levels. All aspects of this procedure will otherwise be the same as for the AIH procedure. Breathing, muscle activity and heart activity will be monitored before, during and after the procedure.
|
Healthy Control Group
n=6 Participants
Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH), as well as, the 45 minute sham AIH session, consisting of breathing air with normal oxygen levels. Breathing, muscle activity and heart activity will be monitored before, during and after both procedures.
Acute Intermittent Hypoxia: AIH entails continuous breathing as the level of oxygen in the air is decreased, then returned to normal. Participants will alternate between breathing normal air and breathing hypoxic air (air that has less oxygen). Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH). Breathing, muscle activity and heart activity will be monitored before, during and after the procedure. The intervals will last 1 minute each.
Sham Acute Intermittent Hypoxia: Participants will complete the sham acute intermittent hypoxia, consisting of a single 45 minute session of breathing air with normal oxygen levels. All aspects of this procedure will otherwise be the same as for the AIH procedure. Breathing, muscle activity and heart activity will be monitored before, during and after the procedure.
|
ALS Group - Sham Hypoxia
People diagnosed with ALS, underwent a single 45 minute session of acute intermittent hypoxia (AIH), which entails alternating between breathing normal air and breathing sham hypoxia, which is also normal air. Participants completed a single 45 minute session of sham hypoxia.
|
Control Group
Unaffected control participants underwent a single 45 minute session of acute intermittent hypoxia (AIH), which entails alternating between breathing normal air and breathing sham hypoxia, which is also normal air. Participants completed a single 45 minute session of sham hypoxia.
|
|---|---|---|---|---|
|
Occlusion Pressure (P0.1)
Baseline
|
-0.80 cm H2O
Standard Deviation 0.58
|
-0.60 cm H2O
Standard Deviation 0.41
|
—
|
—
|
|
Occlusion Pressure (P0.1)
60 minutes post-AIH
|
-0.83 cm H2O
Standard Deviation 0.72
|
-0.47 cm H2O
Standard Deviation 0.53
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 HoursPopulation: Individuals with an ALS diagnosis and age matched controls.
EMG vector magnitude represents the composite surface EMG activity expressed from eight respiratory muscles (bilateral scalene, sternocleidomastoid, 2nd parasternal, and 8th external intercostal/diaphragm). The vector magnitude was calculated for each participant from the root mean square (RMS) values from each EMG channel, as the square root of the sum of the individual squared EMG channel amplitudes.
Outcome measures
| Measure |
ALS Group
n=13 Participants
Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH), as well as, the 45 minute sham AIH session, consisting of breathing air with normal oxygen levels. Breathing, muscle activity and heart activity will be monitored before, during and after both procedures.
Acute Intermittent Hypoxia: AIH entails continuous breathing as the level of oxygen in the air is decreased, then returned to normal. Participants will alternate between breathing normal air and breathing hypoxic air (air that has less oxygen). Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH). Breathing, muscle activity and heart activity will be monitored before, during and after the procedure. The intervals will last 1 minute each.
Sham Acute Intermittent Hypoxia: Participants will complete the sham acute intermittent hypoxia, consisting of a single 45 minute session of breathing air with normal oxygen levels. All aspects of this procedure will otherwise be the same as for the AIH procedure. Breathing, muscle activity and heart activity will be monitored before, during and after the procedure.
|
Healthy Control Group
n=10 Participants
Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH), as well as, the 45 minute sham AIH session, consisting of breathing air with normal oxygen levels. Breathing, muscle activity and heart activity will be monitored before, during and after both procedures.
Acute Intermittent Hypoxia: AIH entails continuous breathing as the level of oxygen in the air is decreased, then returned to normal. Participants will alternate between breathing normal air and breathing hypoxic air (air that has less oxygen). Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH). Breathing, muscle activity and heart activity will be monitored before, during and after the procedure. The intervals will last 1 minute each.
Sham Acute Intermittent Hypoxia: Participants will complete the sham acute intermittent hypoxia, consisting of a single 45 minute session of breathing air with normal oxygen levels. All aspects of this procedure will otherwise be the same as for the AIH procedure. Breathing, muscle activity and heart activity will be monitored before, during and after the procedure.
|
ALS Group - Sham Hypoxia
People diagnosed with ALS, underwent a single 45 minute session of acute intermittent hypoxia (AIH), which entails alternating between breathing normal air and breathing sham hypoxia, which is also normal air. Participants completed a single 45 minute session of sham hypoxia.
|
Control Group
Unaffected control participants underwent a single 45 minute session of acute intermittent hypoxia (AIH), which entails alternating between breathing normal air and breathing sham hypoxia, which is also normal air. Participants completed a single 45 minute session of sham hypoxia.
|
|---|---|---|---|---|
|
Percentage Change in Respiratory EMG Vector Magnitude
Sham hypoxia
|
-24.5 percentage change from baseline
Standard Error 4.1
|
7.4 percentage change from baseline
Standard Error 13.1
|
—
|
—
|
|
Percentage Change in Respiratory EMG Vector Magnitude
AIH
|
179.8 percentage change from baseline
Standard Error 45.9
|
352.3 percentage change from baseline
Standard Error 99.4
|
—
|
—
|
Adverse Events
ALS- AIH Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Healthy Control- AIH Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
ALS- SHAM GROUP
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Healthy Control- SHAM Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ALS- AIH Group
n=14 participants at risk
Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH), as well as, the 45 minute sham AIH session, consisting of breathing air with normal oxygen levels. Breathing, muscle activity and heart activity will be monitored before, during and after both procedures.
Acute Intermittent Hypoxia: AIH entails continuous breathing as the level of oxygen in the air is decreased, then returned to normal. Participants will alternate between breathing normal air and breathing hypoxic air (air that has less oxygen). Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH). Breathing, muscle activity and heart activity will be monitored before, during and after the procedure. The intervals will last 1 minute each.
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Healthy Control- AIH Group
n=11 participants at risk
Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH), as well as, the 45 minute sham AIH session, consisting of breathing air with normal oxygen levels. Breathing, muscle activity and heart activity will be monitored before, during and after both procedures.
Acute Intermittent Hypoxia: AIH entails continuous breathing as the level of oxygen in the air is decreased, then returned to normal. Participants will alternate between breathing normal air and breathing hypoxic air (air that has less oxygen). Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH). Breathing, muscle activity and heart activity will be monitored before, during and after the procedure. The intervals will last 1 minute each.
Sham Acute Intermittent Hypoxia: Participants will complete the sham acute intermittent hypoxia, consisting of a single 45 minute session of breathing air with normal oxygen levels. All aspects of this procedure will otherwise be the same as for the AIH procedure. Breathing, muscle activity and heart activity will be monitored before, during and after the procedure.
|
ALS- SHAM GROUP
n=14 participants at risk
Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH), as well as, the 45 minute sham AIH session, consisting of breathing air with normal oxygen levels. Breathing, muscle activity and heart activity will be monitored before, during and after both procedures.
Sham Acute Intermittent Hypoxia: Participants will complete the sham acute intermittent hypoxia, consisting of a single 45 minute session of breathing air with normal oxygen levels. All aspects of this procedure will otherwise be the same as for the AIH procedure. Breathing, muscle activity and heart activity will be monitored before, during and after the procedure.
|
Healthy Control- SHAM Group
n=11 participants at risk
Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH), as well as, the 45 minute sham AIH session, consisting of breathing air with normal oxygen levels. Breathing, muscle activity and heart activity will be monitored before, during and after both procedures.
Sham Acute Intermittent Hypoxia: Participants will complete the sham acute intermittent hypoxia, consisting of a single 45 minute session of breathing air with normal oxygen levels. All aspects of this procedure will otherwise be the same as for the AIH procedure. Breathing, muscle activity and heart activity will be monitored before, during and after the procedure.
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|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough and sore throat
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from subject consent through 1 week following the last study visit. This timeframe is approximately 6 weeks.
Adverse event definitions were consistent with clinicaltrials.gov definitions. Participants were asked at the beginning and end of every study visit to report any signs, symptoms, or occurrence that has occurred since their last encounter. Additionally, a final assessment was conducted by phone, approximately one week after the last study visit.
|
0.00%
0/11 • Adverse events were collected from subject consent through 1 week following the last study visit. This timeframe is approximately 6 weeks.
Adverse event definitions were consistent with clinicaltrials.gov definitions. Participants were asked at the beginning and end of every study visit to report any signs, symptoms, or occurrence that has occurred since their last encounter. Additionally, a final assessment was conducted by phone, approximately one week after the last study visit.
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from subject consent through 1 week following the last study visit. This timeframe is approximately 6 weeks.
Adverse event definitions were consistent with clinicaltrials.gov definitions. Participants were asked at the beginning and end of every study visit to report any signs, symptoms, or occurrence that has occurred since their last encounter. Additionally, a final assessment was conducted by phone, approximately one week after the last study visit.
|
0.00%
0/11 • Adverse events were collected from subject consent through 1 week following the last study visit. This timeframe is approximately 6 weeks.
Adverse event definitions were consistent with clinicaltrials.gov definitions. Participants were asked at the beginning and end of every study visit to report any signs, symptoms, or occurrence that has occurred since their last encounter. Additionally, a final assessment was conducted by phone, approximately one week after the last study visit.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory congestion
|
0.00%
0/14 • Adverse events were collected from subject consent through 1 week following the last study visit. This timeframe is approximately 6 weeks.
Adverse event definitions were consistent with clinicaltrials.gov definitions. Participants were asked at the beginning and end of every study visit to report any signs, symptoms, or occurrence that has occurred since their last encounter. Additionally, a final assessment was conducted by phone, approximately one week after the last study visit.
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from subject consent through 1 week following the last study visit. This timeframe is approximately 6 weeks.
Adverse event definitions were consistent with clinicaltrials.gov definitions. Participants were asked at the beginning and end of every study visit to report any signs, symptoms, or occurrence that has occurred since their last encounter. Additionally, a final assessment was conducted by phone, approximately one week after the last study visit.
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from subject consent through 1 week following the last study visit. This timeframe is approximately 6 weeks.
Adverse event definitions were consistent with clinicaltrials.gov definitions. Participants were asked at the beginning and end of every study visit to report any signs, symptoms, or occurrence that has occurred since their last encounter. Additionally, a final assessment was conducted by phone, approximately one week after the last study visit.
|
0.00%
0/11 • Adverse events were collected from subject consent through 1 week following the last study visit. This timeframe is approximately 6 weeks.
Adverse event definitions were consistent with clinicaltrials.gov definitions. Participants were asked at the beginning and end of every study visit to report any signs, symptoms, or occurrence that has occurred since their last encounter. Additionally, a final assessment was conducted by phone, approximately one week after the last study visit.
|
|
Musculoskeletal and connective tissue disorders
Wrist sprain
|
0.00%
0/14 • Adverse events were collected from subject consent through 1 week following the last study visit. This timeframe is approximately 6 weeks.
Adverse event definitions were consistent with clinicaltrials.gov definitions. Participants were asked at the beginning and end of every study visit to report any signs, symptoms, or occurrence that has occurred since their last encounter. Additionally, a final assessment was conducted by phone, approximately one week after the last study visit.
|
0.00%
0/11 • Adverse events were collected from subject consent through 1 week following the last study visit. This timeframe is approximately 6 weeks.
Adverse event definitions were consistent with clinicaltrials.gov definitions. Participants were asked at the beginning and end of every study visit to report any signs, symptoms, or occurrence that has occurred since their last encounter. Additionally, a final assessment was conducted by phone, approximately one week after the last study visit.
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from subject consent through 1 week following the last study visit. This timeframe is approximately 6 weeks.
Adverse event definitions were consistent with clinicaltrials.gov definitions. Participants were asked at the beginning and end of every study visit to report any signs, symptoms, or occurrence that has occurred since their last encounter. Additionally, a final assessment was conducted by phone, approximately one week after the last study visit.
|
0.00%
0/11 • Adverse events were collected from subject consent through 1 week following the last study visit. This timeframe is approximately 6 weeks.
Adverse event definitions were consistent with clinicaltrials.gov definitions. Participants were asked at the beginning and end of every study visit to report any signs, symptoms, or occurrence that has occurred since their last encounter. Additionally, a final assessment was conducted by phone, approximately one week after the last study visit.
|
|
Skin and subcutaneous tissue disorders
Shingles
|
0.00%
0/14 • Adverse events were collected from subject consent through 1 week following the last study visit. This timeframe is approximately 6 weeks.
Adverse event definitions were consistent with clinicaltrials.gov definitions. Participants were asked at the beginning and end of every study visit to report any signs, symptoms, or occurrence that has occurred since their last encounter. Additionally, a final assessment was conducted by phone, approximately one week after the last study visit.
|
0.00%
0/11 • Adverse events were collected from subject consent through 1 week following the last study visit. This timeframe is approximately 6 weeks.
Adverse event definitions were consistent with clinicaltrials.gov definitions. Participants were asked at the beginning and end of every study visit to report any signs, symptoms, or occurrence that has occurred since their last encounter. Additionally, a final assessment was conducted by phone, approximately one week after the last study visit.
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from subject consent through 1 week following the last study visit. This timeframe is approximately 6 weeks.
Adverse event definitions were consistent with clinicaltrials.gov definitions. Participants were asked at the beginning and end of every study visit to report any signs, symptoms, or occurrence that has occurred since their last encounter. Additionally, a final assessment was conducted by phone, approximately one week after the last study visit.
|
0.00%
0/11 • Adverse events were collected from subject consent through 1 week following the last study visit. This timeframe is approximately 6 weeks.
Adverse event definitions were consistent with clinicaltrials.gov definitions. Participants were asked at the beginning and end of every study visit to report any signs, symptoms, or occurrence that has occurred since their last encounter. Additionally, a final assessment was conducted by phone, approximately one week after the last study visit.
|
|
Cardiac disorders
Tachycardia
|
7.1%
1/14 • Number of events 1 • Adverse events were collected from subject consent through 1 week following the last study visit. This timeframe is approximately 6 weeks.
Adverse event definitions were consistent with clinicaltrials.gov definitions. Participants were asked at the beginning and end of every study visit to report any signs, symptoms, or occurrence that has occurred since their last encounter. Additionally, a final assessment was conducted by phone, approximately one week after the last study visit.
|
0.00%
0/11 • Adverse events were collected from subject consent through 1 week following the last study visit. This timeframe is approximately 6 weeks.
Adverse event definitions were consistent with clinicaltrials.gov definitions. Participants were asked at the beginning and end of every study visit to report any signs, symptoms, or occurrence that has occurred since their last encounter. Additionally, a final assessment was conducted by phone, approximately one week after the last study visit.
|
0.00%
0/14 • Adverse events were collected from subject consent through 1 week following the last study visit. This timeframe is approximately 6 weeks.
Adverse event definitions were consistent with clinicaltrials.gov definitions. Participants were asked at the beginning and end of every study visit to report any signs, symptoms, or occurrence that has occurred since their last encounter. Additionally, a final assessment was conducted by phone, approximately one week after the last study visit.
|
0.00%
0/11 • Adverse events were collected from subject consent through 1 week following the last study visit. This timeframe is approximately 6 weeks.
Adverse event definitions were consistent with clinicaltrials.gov definitions. Participants were asked at the beginning and end of every study visit to report any signs, symptoms, or occurrence that has occurred since their last encounter. Additionally, a final assessment was conducted by phone, approximately one week after the last study visit.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place