Respiratory and Autonomic Plasticity Following Intermittent Hypoxia (RAP-IH)
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|ClinicalTrials.gov Identifier: NCT00860743|
Recruitment Status : Completed
First Posted : March 12, 2009
Results First Posted : February 25, 2015
Last Update Posted : November 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea Syndromes||Drug: Antioxidant cocktail||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Respiratory and Autonomic Plasticity Following Intermittent Hypoxia|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
No Intervention: Arm 1
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.
Experimental: ANTIOXIDANT COCKTAIL
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.
Drug: 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.
- Ventilation (Aim 1) [ Time Frame: Within the same experimental session ]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.
- Heart Rate Variability (Aim 2) [ Time Frame: Within the same experimental session ]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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00860743
|United States, Michigan|
|John D. Dingell VA Medical Center, Detroit|
|Detroit, Michigan, United States, 48201|
|Principal Investigator:||Jason H Mateika, PhD MS BS||John D. Dingell VA Medical Center, Detroit|