RECRUITING Phase 4 ClinicalTrials.gov

Sleep Apnea in Elderly

Sponsor: VA Office of Research and Development • ClinicalTrials.gov ID: NCT02703220

Registry updated: 2026-08-21

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Description

Sleep-disordered breathing (SDB or sleep apnea) is very common among elderly Veterans and leads to increased morbidity and mortality in this population. The proposal aims to identity whether oxygen, finasteride and acetazolamide can be effective in reducing unstable breathing and eliminating sleep apnea in the elderly via different mechanisms. This proposal will enhance the investigators' understanding of the pathways that contribute to the development of sleep apnea in the elderly. The investigators expect that the results obtained from this study will positively impact the health of Veterans by identifying new treatment modalities for sleep apnea. A cumulative effect of the investigators' research will fulfill the long-term goal of improving the quality of life of elderly Veterans suffering from sleep apnea and its potential life-threatening complications.

Interventions

Hyperoxia/oxygen (Other)
The ventilatory effects of brief hyperoxia will be assessed by analyzing control breaths on room air immediately preceding the hyperoxic exposure, and comparing with the primary end-point, nadir minute ventilation breath, immediately following the brief hyperoxic exposure
Acetazolamide (Drug)
Participants with sleep apnea will ingest capsules containing either placebo or acetazolamide 500 mg twice a day for 5 days. On the final 2 consecutive nights while still on ACZ, the investigators will perform i) physiology tests and ii) in-lab follow-up PSG.
Finasteride (Drug)
Elderly males with sleep apnea and adequate testosterone levels will ingest placebo vs finasteride, at 5 mg a day for 1 month (mo). After 1 mo, while still on the drug, on the final 2 consecutive nights, the investigators will perform i) physiology tests and ii) in-lab follow-up PSG. Blood tests will be performed to check sex hormone levels. A washout period of 1 month prior to cross-over to the alternate arm (placebo).

Eligibility criteria

Inclusion Criteria: * Adults with mild to moderate sleep apnea with Apnea-Hypopnea Index (AHI)\>/=5 to 20/hour with central, obstructive, mixed apneas and hypopneas * For the finasteride protocol elderly men with above criteria will be enrolled Exclusion Criteria: * Patients with severe sleep apnea (Apnea-Hypopnea Index (AHI)\>20/hour) * Patients with history of prostate cancer * Males with hypogonadism * History of cardiac disease, including myocardial infarction * Bypass surgery * Atrial and ventricular tachy-bradycardias * Systolic congestive heart failure and Cheyne-Stokes respiration * Current unstable angina * Stroke * Schizophrenia * Untreated hypothyroidism * Seizure disorder * Preexisting renal failure and liver disorders * Failure to give informed consent. * Patients with significant pulmonary diseases by history and abnormal pulmonary function testing, including moderate obstructive/restrictive lung/chest wall disorders with resting oxygen saturation of \<96% or on supplemental oxygen * Patients on certain medications including: * study drugs * sympathomimetics/parasympathomimetics or their respective blockers * narcotics * antidepressants * anti-psychotic agents * other central nervous system (CNS) altering medications * current alcohol, tobacco or recreational drug use * Patients with Body mass index (BMI)\>34 kilograms per square meter (kg/m2) will be excluded to avoid the effects of morbid obesity on pulmonary mechanics and ventilatory control * Elderly with unstable gait or mobility issues that may preclude safe participation * Individuals with allergy to finasteride or acetazolamide will be excluded from the specific protocol * Pregnant women

Conditions

Sleep Apnea Elderly Adults

Locations

John D. Dingell VA Medical Center, Detroit, MI — Detroit, Michigan, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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