Sleep Apnea in Elderly

Pathophysiology-Guided Therapy for Sleep Apnea in the Elderly

Sleep Apnea in Elderly (NCT02703220) is a Phase 4 interventional studying Sleep Apnea and Elderly Adults, sponsored by VA Office of Research and Development. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 100 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Sleep Apnea subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Adults who are 60 years old and older, with mild to moderate sleep apnea with AHI \>/=5 to 20/hr with central, obstructive, mixed apneas and hypopneas. - For the finasteride protocol elderly men with above criteria will be enrolled. Who Should NOT Join This Trial: - Patients with severe sleep apnea (AHI\>20/hr) - 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 willing to sign a consent form. - 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 BMI\>34kg/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 Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Adults who are 60 years old and older, with mild to moderate sleep apnea with AHI \>/=5 to 20/hr 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 (AHI\>20/hr) * 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 BMI\>34kg/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

Treatments Being Tested

OTHER

Hyperoxia/oxygen

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

DRUG

Acetazolamide

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.

DRUG

Finasteride

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).

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

John D. Dingell VA Medical Center, Detroit, MI

Detroit, Michigan, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT02703220), the sponsor (VA Office of Research and Development), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT02703220 clinical trial studying?

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… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT02703220?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT02703220?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT02703220. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT02703220. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.