Trial Outcomes & Findings for Intermittent Hypoxia to Enhance Motor Function After Spinal Cord Injury (NCT NCT03071393)
NCT ID: NCT03071393
Last Updated: 2023-11-18
Results Overview
An assessment of inspiratory muscle strength.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
17 participants
Primary outcome timeframe
Change between baseline and 30 minutes post-intermittent hypoxia or sham.
Results posted on
2023-11-18
Participant Flow
Individuals were recruited through advertisements and rehabilitation health facilities in north Florida. Recruitment occurred from 07/2017 through 12/2019.
Participant milestones
| Measure |
Acute Intermittent Hypoxia, Then Sham Intermittent Hypoxia
Subjects with chronic spinal cord injury first received an acute intermittent hypoxia protocol with low oxygen air (9-15% inspired oxygen). After a washout period of at least one week, they then received sham intermittent hypoxia with normal oxygen air (21% inspired oxygen).
Hypoxico Hyp-123: During acute intermittent hypoxia, subjects will undergo 15 brief exposures (60-120 seconds) of low oxygen air (9-15% inspired oxygen) delivered by an air generator, alternated with 15 brief exposures (60-120 seconds) of ambient room air.
|
Sham Intermittent Hypoxia, Then Acute Intermittent Hypoxia
Subjects with chronic spinal cord injury first received a sham (placebo) intermittent hypoxia protocol with normal oxygen air (21% inspired oxygen). After a washout period of at least one week, they then received an acute intermittent hypoxia protocol with low oxygen air (9-15% inspired oxygen).
Hypoxico Hyp-123: During sham intermittent hypoxia, subjects will undergo 15 brief exposures (60-120 seconds) of normal oxygen air (21% inspired oxygen) delivered by an air generator, alternated with 15 brief exposures (60-120 seconds) of ambient room air.
|
|---|---|---|
|
First Intervention (Single Day Session)
STARTED
|
7
|
10
|
|
First Intervention (Single Day Session)
COMPLETED
|
7
|
10
|
|
First Intervention (Single Day Session)
NOT COMPLETED
|
0
|
0
|
|
Washout (at Least 7 Days)
STARTED
|
7
|
10
|
|
Washout (at Least 7 Days)
COMPLETED
|
7
|
10
|
|
Washout (at Least 7 Days)
NOT COMPLETED
|
0
|
0
|
|
Intervention 2 (Single Day Session)
STARTED
|
7
|
10
|
|
Intervention 2 (Single Day Session)
COMPLETED
|
7
|
10
|
|
Intervention 2 (Single Day Session)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Study Participants
n=17 Participants
Subjects with chronic spinal cord injury completed a single session of acute intermittent hypoxia with low oxygen air (15 exposures of 60-120 seconds, 9-15% inspired oxygen, alternated with 60-120 seconds of room air) and a single session of sham acute intermittent hypoxia with room air (15 exposures of room air, 60-120 seconds, 21% oxygen). A washout of at least 7 days separated the two sessions.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=17 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=17 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=17 Participants
|
|
Age, Continuous
|
34.1 years
STANDARD_DEVIATION 14.5 • n=17 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=17 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=17 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=17 Participants
|
|
ASIA Impairment Scale
AIS A Complete SCI
|
6 Participants
n=17 Participants
|
|
ASIA Impairment Scale
AIS B motor complete SCI
|
7 Participants
n=17 Participants
|
|
ASIA Impairment Scale
AIS C motor incomplete
|
3 Participants
n=17 Participants
|
|
ASIA Impairment Scale
AIS D motor incomplete
|
1 Participants
n=17 Participants
|
|
Spinal Cord Injury chronicity
|
63.1 months
STANDARD_DEVIATION 112.9 • n=17 Participants
|
|
Upper Extremity Motor Score (UEMS)
|
40.2 units on a scale
STANDARD_DEVIATION 15.3 • n=17 Participants
|
|
Lower Extremity Motor Score (LEMS)
|
4.6 units on a scale
STANDARD_DEVIATION 12.4 • n=17 Participants
|
PRIMARY outcome
Timeframe: Change between baseline and 30 minutes post-intermittent hypoxia or sham.Population: All participants completed the measure and were analyzed
An assessment of inspiratory muscle strength.
Outcome measures
| Measure |
All Study Participants - Acute Intermittent Hypoxia
n=17 Participants
Subjects with chronic spinal cord injury completed a single session of acute intermittent hypoxia with low oxygen air (15 exposures of 60-120 seconds, 9-15% inspired oxygen, alternated with 60-120 seconds of room air) Individuals were 13 males; 34.1 ± 14.5 years old; 13 motor complete SCI; \>6 months post injury
|
All Study Participants - Sham
n=17 Participants
Subjects with chronic spinal cord injury completed a single session of acute sham intermittent hypoxia with room air Individuals were 13 males; 34.1 ± 14.5 years old; 13 motor complete SCI; \>6 months post injury
|
|---|---|---|
|
Change in Maximal Inspiratory Pressure
|
8.2 cmH2O
Standard Deviation 12.3
|
-3.0 cmH2O
Standard Deviation 11.3
|
PRIMARY outcome
Timeframe: Change between baseline and 30 minutes post-intermittent hypoxia or sham.Population: All participants completed the measure and were analyzed
An assessment of expiratory muscle strength.
Outcome measures
| Measure |
All Study Participants - Acute Intermittent Hypoxia
n=17 Participants
Subjects with chronic spinal cord injury completed a single session of acute intermittent hypoxia with low oxygen air (15 exposures of 60-120 seconds, 9-15% inspired oxygen, alternated with 60-120 seconds of room air) Individuals were 13 males; 34.1 ± 14.5 years old; 13 motor complete SCI; \>6 months post injury
|
All Study Participants - Sham
n=17 Participants
Subjects with chronic spinal cord injury completed a single session of acute sham intermittent hypoxia with room air Individuals were 13 males; 34.1 ± 14.5 years old; 13 motor complete SCI; \>6 months post injury
|
|---|---|---|
|
Change in Maximal Expiratory Pressure
|
4.3 cmH2O
Standard Deviation 11.5
|
2.9 cmH2O
Standard Deviation 9.8
|
PRIMARY outcome
Timeframe: Change between baseline and 30 minutes post-intermittent hypoxia or sham.Population: The measure was not obtained on 3 participants
An assessment of how much air a person can forcefully exhale after a maximal inspiratory effort.
Outcome measures
| Measure |
All Study Participants - Acute Intermittent Hypoxia
n=14 Participants
Subjects with chronic spinal cord injury completed a single session of acute intermittent hypoxia with low oxygen air (15 exposures of 60-120 seconds, 9-15% inspired oxygen, alternated with 60-120 seconds of room air) Individuals were 13 males; 34.1 ± 14.5 years old; 13 motor complete SCI; \>6 months post injury
|
All Study Participants - Sham
n=14 Participants
Subjects with chronic spinal cord injury completed a single session of acute sham intermittent hypoxia with room air Individuals were 13 males; 34.1 ± 14.5 years old; 13 motor complete SCI; \>6 months post injury
|
|---|---|---|
|
Change in Forced Vital Capacity
|
-0.01 Liters
Standard Deviation 0.17
|
0.00 Liters
Standard Deviation 0.21
|
PRIMARY outcome
Timeframe: Change between baseline and 30 minutes post-intermittent hypoxia or sham.Population: This measure was obtained in 12 participants. 12 participants were analyzed.
An assessment of the pressure generated in the first 0.1 seconds of the participant's initiation of inhalation.
Outcome measures
| Measure |
All Study Participants - Acute Intermittent Hypoxia
n=12 Participants
Subjects with chronic spinal cord injury completed a single session of acute intermittent hypoxia with low oxygen air (15 exposures of 60-120 seconds, 9-15% inspired oxygen, alternated with 60-120 seconds of room air) Individuals were 13 males; 34.1 ± 14.5 years old; 13 motor complete SCI; \>6 months post injury
|
All Study Participants - Sham
n=12 Participants
Subjects with chronic spinal cord injury completed a single session of acute sham intermittent hypoxia with room air Individuals were 13 males; 34.1 ± 14.5 years old; 13 motor complete SCI; \>6 months post injury
|
|---|---|---|
|
Change in Mouth Occlusion Pressure (P0.1)
|
0.24 cmH2O
Standard Deviation 0.30
|
0.15 cmH2O
Standard Deviation 0.50
|
Adverse Events
Acute Intermittent Hypoxia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Intermittent Hypoxia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Emily Fox, Principal Investigator
University of Florida
Phone: 904-742-2500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place