Recruiting

Observational Study

Sponsor:

VA Office of Research and Development

Code:

NCT02703220

Conditions

Sleep Apnea

Elderly Adults

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Accepted

Interventions

Hyperoxia/oxygen

Acetazolamide

Finasteride

Study Details

Brief summary:

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.

Conditions

Sleep Apnea

Elderly Adults

Study ID

NCT02703220

Start date

Jul 3, 2015

Status verified date

Aug, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jul 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Hyperoxia

Determine the effect of sustained hyperoxia overnight vs room air overnight on ventilatory control during sleep, including the apneic threshold, carbon-dioxide reserve and chemosensitivity measured via pressure support ventilation (PSV) during (non-rapid eye movement sleep) NREM sleep.

experimental: Acetazolamide (ACZ)

Determine the effect of acetazolamide on cerebrovascular responsiveness to CO2 during wake and sleep. Participants will receive oral ACZ therapy for 7 days prior to the experimental night, on the night of the study and the subsequent night when polysomnography (PSG) will be performed.

experimental: Finasteride

Determine the effect of oral finasteride therapy vs placebo for 1 month on SDB and the AT and chemosensitivity during NREM sleep.

Interventions

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

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.

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).

Primary outcome measure

  • Apneic threshold- a measure of breathing instability [ Time Frame: 2 days to 30 days ]
  • Cerebrovascular responsiveness to carbon-dioxide [ Time Frame: 7 days ]
  • Ventilatory responsiveness [ Time Frame: 2 days to 30 days ]
  • Carbon -dioxide reserve [ Time Frame: 2 days to 30 days ]

Central Contacts and Locations

Central contacts

Ruchi Rastogi, MS

(313) 576-4464ruchi.rastogi@va.gov

Locations

John D. Dingell VA Medical Center, Detroit, MI

Recruiting

Detroit, Michigan, United States, 48201-1916

Contacts

Lynn M Huber

(313) 576-3106lynn.huber@va.gov

Principal Investigator:

Susmita Chowdhuri, MD MS

More Information

Sponsor

VA Office of Research and Development

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Keywords

  • sleep apnea
  • chemoresponsiveness
  • cerebrovascular response
  • hyperoxia
  • acetazolamide
  • finasteride
  • apneic threshold
  • carbon-dioxide reserve

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-08-21.