Early Phase 1
N=63
Respiratory and Autonomic Plasticity Following Intermittent Hypoxia
Sleep Apnea Syndromes
Bottom Line
View on ClinicalTrials.gov: NCT00860743 ↗Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcome: Primary: Ventilation (Aim 1) — 1.19; 1.14; 1.35; 1.16 fraction of baseline — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Antioxidant cocktail (Drug)
- Age
- Adult · 20+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ventilation (Aim 1) |
1.19; 1.14; 1.35; 1.16; 1.19; 1.09 | 0.001 sig |
| PRIMARY Heart Rate Variability (Aim 2) |
3766.1; 2944.9; 3810.5; 2516.3; 2737.7; 2289.1 | 0.2 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
Characteristics of OSA subject population:
- Body mass index apnea/hypopnea index >10 events per hour - average nocturnal oxygen saturation > 90%).
- Not pregnant.
- Free of any other known medical conditions.
- Not taking any medication.
- Non-smokers with normal lung function.
- Minimal alcohol consumption (i.e. no more than the equivalent of a glass of wine/day).
Characteristics of control group population:
- Body mass index < 30 kg/m2.
- 20 to 40 years old.
- Apnea/hypopnea index < 5 events per hour.
- Not pregnant.
- Free of any known medical conditions.
- Not taking any medication.
- Non-smokers with normal lung function.
- Minimal alcohol consumption (i.e. no more than the equivalent of a glass of wine/day).
Exclusion Criteria
- Anything not in inclusion criteria.
Data sourced from ClinicalTrials.gov (NCT00860743). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.