CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 63 enrolled
Drug / intervention
Antioxidant cocktaildrug
Likely dose
Antioxidant cocktail 120 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00860743
NCT00860743Early Ph 1Completed

Respiratory and Autonomic Plasticity Following Intermittent Hypoxia

VA Office of Research and Development·interventional·Posted Mar 12, 2009·Updated Nov 1, 2017

In Brief

A Early Phase 1 clinical trial evaluating Antioxidant cocktail for Sleep Apnea Syndromes. Completed, enrolled 63 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Early Ph 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 12, 2009
Enrollment StartSep 1, 2009
Primary CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 17.3 years ago

Interventions

Antioxidant cocktaildrug

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.