NCT00860743|CompletedEarly Phase 1ResultsDMC
Respiratory and Autonomic Plasticity Following Intermittent Hypoxia
RAP-IH
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Sponsor study identifier
Secondary identifiers
OTHER_GRANT · VA Merit
interventional
63
1 country
1
Study Start
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2013
Actual (reported)Study Completion
September 2013
Actual (reported)The prevalence of obstructive sleep apnea is high in the Veteran population. If not treated promptly, sleep apnea may result in daytime fatigue which may lead to increased prevalence of accidents while driving or in the workplace. Recent large scale epidemiological studies have shown that the prevalence of excessive daytime sleepiness increases in individuals who suffer from obstructive sleep apnea. Obstructive sleep apnea may also result in the development of hypertension and other cardiovascular disorders. Previous findings have shown that subjects with sleep apnea have a greater risk for developing coronary vascular disease compared to individuals that do not suffer from sleep apnea Thus, a significant amount of evidence suggests that sleep apnea is a major health concern in the Veteran population. Consequently, determining the mechanisms that may impact on the severity of sleep apnea and increase the prevalence of cardiovascular incidents associated with this disorder is important, as is discovering novel treatments.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2013
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 10, 2009
Actual (reported)March 12, 2009
Actual (reported)September 2009
Date type not reportedThis date has not been verified as actual or estimated.
September 2013
Actual (reported)September 2013
Actual (reported)February 25, 2015
Actual (reported)Ventilation (Aim 1)
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.
Within the same experimental session
Heart Rate Variability (Aim 2)
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.
Within the same experimental session
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.
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
John D. Dingell VA Medical Center, Detroit
Detroit, Michigan, 48201, United States
Mateika JH, Syed Z. Intermittent hypoxia, respiratory plasticity and sleep apnea in humans: present knowledge and future investigations. Respir Physiol Neurobiol. 2013 Sep 15;188(3):289-300. doi: 10.1016/j.resp.2013.04.010. Epub 2013 Apr 12.
Syed Z, Lin HS, Mateika JH. The impact of arousal state, sex, and sleep apnea on the magnitude of progressive augmentation and ventilatory long-term facilitation. J Appl Physiol (1985). 2013 Jan 1;114(1):52-65. doi: 10.1152/japplphysiol.00985.2012. Epub 2012 Nov 8.
The primary limitation of this trial was the number of participants that required screening to recruit the participants that met the inclusion criteria for the study. However, once the participants were recruited few withdrew.
Jason H Mateika, PhD MS BS
John D. Dingell VA Medical Center, Detroit
63 participants (actual enrollment reported by the registry).
First Submitted
March 10, 2009
First Posted
March 12, 2009
Study Start
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
Using Telemedicine to Improve Veteran Sleep Apnea Care
Enabling Sleep Apnea Patient-Centered Care Via an Internet Intervention
Contact the study team to confirm eligibility.
Primary Completion
September 2013
Actual (reported)Study Completion
September 2013
Actual (reported)Last Updated
November 1, 2017
Results First Posted
February 25, 2015
Record last verified: 2017-09
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Source: ClinicalTrials.gov.
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