NCT02703220 · VA Office of Research and Development
Sleep Apnea in Elderly
What this study is about
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.
View original scientific 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
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).
Primary outcome measures
Apneic threshold- a measure of breathing instability
Time frame: 2 days to 30 days
Measures of breathing instability including: Apneic threshold: this is the end-tidal Co2 at which a central apnea closes to a hypopnea is produced.
Cerebrovascular responsiveness to carbon-dioxide
Time frame: 7 days
Cerebrovascular response to different levels of CO2: this is a measure of the response of the cerebral blood flow to changes in carbon dioxide levels and is used as a measure of ventilatory control of breathing
Ventilatory responsiveness
Time frame: 2 days to 30 days
Hypocapnic ventilatory response; this is calculated as the change in minute ventilation for corresponding changes in PETCO2 (partial pressure of end-tidal carbon dioxide).
Carbon -dioxide reserve
Time frame: 2 days to 30 days
This is a derived measure. This is calculated as the difference between the apneic threshold PETCO2 (given above) and the control PETCO2 (partial pressure of end-tidal carbon dioxide).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
- 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
Where
- Detroit, Michigan
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 21, 2026 · Source of record for eligibility and locations