Trial Outcomes & Findings for Respiratory and Autonomic Plasticity Following Intermittent Hypoxia (NCT NCT00860743)
NCT ID: NCT00860743
Last Updated: 2017-11-01
Results Overview
Ventilation was measured before and after exposure to intermittent hypoxia in males and females. Ventilation was measured using a pneumotachograph, which is a flow measuring device.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
63 participants
Primary outcome timeframe
Within the same experimental session
Results posted on
2017-11-01
Participant Flow
This study recruited participants between the years 2009-2013. The study was completed at the John D. Dingell VA Medical Center.
1. Participants did not meet the inclusion criteria. This was typically due to EKG abnormalities or high blood pressure. 2. Participants completed a "practice run" following consent to introduce them to equipment and procedures. Some participants choose not to continue following the practice run usually because of discomfort.
Participant milestones
| Measure |
OSA/Healthy - Males/Females - Wake/Sleep
We plan to study 10 males and 10 females with moderate obstructive sleep apnea (OSA), and 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and "sham" intermittent hypoxia during wakefulness and sleep.
|
Arm 2
We plan to study 10 male participants with moderate obstructive sleep apnea (OSA) and 10 male control participants matched for age, race and body mass index. The OSA and control participants will be exposed to intermittent hypoxia during wakefulness and sleep following administration of an antioxidant or a placebo cocktail that will be presented in a randomized fashion.
Antioxidant cocktail: 120 mg of Coenzyme Q10 (orally), 800 mg of Superoxide Dismutase (orally), 400 IU of Vitamin E (orally) before exposure to intermittent hypoxia. Two doses of 1 g of Vitamin C in 50 cc of saline IV (in the vein) before and after exposure to intermittent hypoxia.
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|---|---|---|
|
Overall Study
STARTED
|
40
|
23
|
|
Overall Study
COMPLETED
|
37
|
23
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
OSA/Healthy - Males/Females - Wake/Sleep
We plan to study 10 males and 10 females with moderate obstructive sleep apnea (OSA), and 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and "sham" intermittent hypoxia during wakefulness and sleep.
|
Arm 2
We plan to study 10 male participants with moderate obstructive sleep apnea (OSA) and 10 male control participants matched for age, race and body mass index. The OSA and control participants will be exposed to intermittent hypoxia during wakefulness and sleep following administration of an antioxidant or a placebo cocktail that will be presented in a randomized fashion.
Antioxidant cocktail: 120 mg of Coenzyme Q10 (orally), 800 mg of Superoxide Dismutase (orally), 400 IU of Vitamin E (orally) before exposure to intermittent hypoxia. Two doses of 1 g of Vitamin C in 50 cc of saline IV (in the vein) before and after exposure to intermittent hypoxia.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
Baseline Characteristics
Respiratory and Autonomic Plasticity Following Intermittent Hypoxia
Baseline characteristics by cohort
| Measure |
Aim 1 - OSA Male - Sleep/Wake - Hypoxia/Sham
n=11 Participants
We plan to study 10 OSA males. These males will be matched with 10 females with moderate obstructive sleep apnea (OSA), 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and "sham" intermittent hypoxia during wakefulness and sleep.
|
Aim 1 - OSA Female- Sleep/Wake - Hypoxia/Sham
n=7 Participants
We plan to study 10 OSA females. These females will be matched with 10 males with moderate obstructive sleep apnea (OSA), 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and "sham" intermittent hypoxia during wakefulness and sleep.
|
Aim 1 - Healthy Males- Sleep/Wake - Hypoxia/Sham
n=12 Participants
We plan to study 10 healthy males. These males will be matched with 10 OSA males and 10 OSA females with moderate obstructive sleep apnea (OSA), and 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and "sham" intermittent hypoxia during wakefulness and sleep.
|
Aim 1 - Healthy Females- Sleep/Wake - Hypoxia/Sham
n=10 Participants
We plan to study 10 males and 10 females with moderate obstructive sleep apnea (OSA), and 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and "sham" intermittent hypoxia during wakefulness and sleep.
|
Aim 2 - OSA - Hypoxia - Antioxidant/Placebo
n=13 Participants
We plan to study 10 male participants with moderate obstructive sleep apnea (OSA) and 10 male control participants matched for age, race and body mass index. The OSA and control participants will be exposed to intermittent hypoxia during wakefulness following administration of an antioxidant or a placebo cocktail that will be presented in a randomized fashion.
Antioxidant cocktail: 120 mg of Coenzyme Q10 (orally), 800 mg of Superoxide Dismutase (orally), 400 IU of Vitamin E (orally) before exposure to intermittent hypoxia. Two doses of 1 g of Vitamin C in 50 cc of saline IV (in the vein) before and after exposure to intermittent hypoxia.
|
Aim 2 - Healthy - Hypoxia - Antioxidant/Placebo
n=10 Participants
We plan to study 10 male participants with moderate obstructive sleep apnea (OSA) and 10 male control participants matched for age, race and body mass index. The OSA and control participants will be exposed to intermittent hypoxia during wakefulness following administration of an antioxidant or a placebo cocktail that will be presented in a randomized fashion.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Customized
|
24.8 years
STANDARD_DEVIATION 3.1 • n=5 Participants
|
26.6 years
STANDARD_DEVIATION 5.9 • n=7 Participants
|
25.2 years
STANDARD_DEVIATION 4.0 • n=5 Participants
|
24.8 years
STANDARD_DEVIATION 4.1 • n=4 Participants
|
31.2 years
STANDARD_DEVIATION 6.2 • n=21 Participants
|
29.1 years
STANDARD_DEVIATION 5.1 • n=10 Participants
|
26.6 years
STANDARD_DEVIATION 5.4 • n=115 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
17 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
46 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
62 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
30 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
33 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
7 participants
n=7 Participants
|
12 participants
n=5 Participants
|
10 participants
n=4 Participants
|
13 participants
n=21 Participants
|
10 participants
n=10 Participants
|
63 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Within the same experimental sessionVentilation was measured before and after exposure to intermittent hypoxia in males and females. Ventilation was measured using a pneumotachograph, which is a flow measuring device.
Outcome measures
| Measure |
OSA/HEALTHY - MALES/FEMALES - WAKE/SLEEP
n=37 Participants
We plan to study 10 males and 10 females with moderate obstructive sleep apnea (OSA), and 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and "sham" intermittent hypoxia during wakefulness and sleep.
|
|---|---|
|
Ventilation (Aim 1)
Healthy female during wakefulness
|
1.26 fraction of baseline
Standard Error 0.06
|
|
Ventilation (Aim 1)
Healthy female during sleep
|
1.08 fraction of baseline
Standard Error 0.04
|
|
Ventilation (Aim 1)
OSA male during wakefulness
|
1.19 fraction of baseline
Standard Error 0.03
|
|
Ventilation (Aim 1)
OSA male during sleep
|
1.14 fraction of baseline
Standard Error 0.03
|
|
Ventilation (Aim 1)
OSA female during wakefulness
|
1.35 fraction of baseline
Standard Error 0.03
|
|
Ventilation (Aim 1)
OSA female during sleep
|
1.16 fraction of baseline
Standard Error 0.05
|
|
Ventilation (Aim 1)
Healthy male during wakefulness
|
1.19 fraction of baseline
Standard Error 0.03
|
|
Ventilation (Aim 1)
Healthy male during sleep
|
1.09 fraction of baseline
Standard Error 0.03
|
PRIMARY outcome
Timeframe: Within the same experimental sessionPopulation: Measurements were made before and after intermittent hypoxia following administration of a placebo or antioxidant cocktail. Please note that analysis of the heart rate variability measures for the healthy group have not been completed to date.
Heart rate variability (HRV) was measured before and after exposure to intermittent hypoxia following administration of a placebo or antioxidant cocktail. Heart rate variability refers to beat-to-beat alterations in heart rate. Under resting conditions, the electrocardiogram of healthy individuals reveals periodic variation in R-R intervals. To measure HRV, R-R interval data are presented in a graph, in which the y-axis plots the R-R intervals (ms2), and the x-axis the total number of beats. Spectral analysis of the graph transforms the signal from time to frequency on the x-axis (Hz), by representing the signal as a combination of sine and cosine waves, with different amplitudes and frequencies. The approach uses Fourier transforms. The heart rate spectrum contains a high frequency (0.15-0.4 Hz) component, which is synchronous with respiration and a low frequency (0.04 to 0.15 Hz) component that appears to be mediated by both the vagus and cardiac sympathetic nerves.
Outcome measures
| Measure |
OSA/HEALTHY - MALES/FEMALES - WAKE/SLEEP
n=13 Participants
We plan to study 10 males and 10 females with moderate obstructive sleep apnea (OSA), and 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and "sham" intermittent hypoxia during wakefulness and sleep.
|
|---|---|
|
Heart Rate Variability (Aim 2)
OSA before intermittent hypoxia placebo (HF)
|
3766.1 ms2/Hz
Standard Error 1129.859
|
|
Heart Rate Variability (Aim 2)
OSA after intermittent hypoxia placebo (HF)
|
2944.9 ms2/Hz
Standard Error 935.0
|
|
Heart Rate Variability (Aim 2)
OSA before intermittent hypoxia antioxidant (HF)
|
3810.5 ms2/Hz
Standard Error 1712.2
|
|
Heart Rate Variability (Aim 2)
OSA after intermittent hypoxia antioxidant (HF)
|
2516.3 ms2/Hz
Standard Error 835.8
|
|
Heart Rate Variability (Aim 2)
OSA before intermittent hypoxia placebo (LF)
|
2737.7 ms2/Hz
Standard Error 573.1
|
|
Heart Rate Variability (Aim 2)
OSA after intermittent hypoxia placebo (LF)
|
2289.1 ms2/Hz
Standard Error 568.1
|
|
Heart Rate Variability (Aim 2)
OSA before intermittent hypoxia antioxidant (LF)
|
2761.6 ms2/Hz
Standard Error 629.1
|
|
Heart Rate Variability (Aim 2)
OSA after intermittent hypoxia antioxidant (LF)
|
1889.9 ms2/Hz
Standard Error 336.3
|
Adverse Events
Arm 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2
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 |
Arm 1
n=40 participants at risk
We plan to study 10 males and 10 females with moderate obstructive sleep apnea (OSA), and 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and "sham" intermittent hypoxia during wakefulness and sleep.
|
Arm 2
n=23 participants at risk
We plan to study 10 male participants with moderate obstructive sleep apnea (OSA) and 10 male control participants matched for age, race and body mass index. The OSA and control participants will be exposed to intermittent hypoxia during wakefulness and sleep following administration of an antioxidant or a placebo cocktail that will be presented in a randomized fashion.
Antioxidant cocktail: 120 mg of Coenzyme Q10 (orally), 800 mg of Superoxide Dismutase (orally), 400 IU of Vitamin E (orally) before exposure to intermittent hypoxia. Two doses of 1 g of Vitamin C in 50 cc of saline IV (in the vein) before and after exposure to intermittent hypoxia.
|
|---|---|---|
|
Cardiac disorders
premature ventricular contraction
|
0.00%
0/40 • 4 years
|
0.00%
0/23 • 4 years
|
Additional Information
Jason H. Mateika
Wayne State University and John D. Dingell VA Medical Center
Phone: 313-576-4481
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place