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NCT Number: NCT02703220

Sleep Apnea in Elderly

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.

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Key information

Age range

60 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

John D. Dingell VA Medical Center, Detroit, MI

Detroit, Michigan, 48201-1916, United States

Location status: Recruiting

Location contact

Lynn M Huber

CONTACT

[email protected]

313-576-3106

Susmita Chowdhuri, MD MS

PRINCIPAL_INVESTIGATOR

About this study

Sleep apnea-hypopnea syndrome (SAHS) has a high prevalence and is associated with adverse cardiovascular consequences in elderly Veterans. Positive airway pressure therapy is deemed cumbersome and often associated with non-adherence to therapy. This proposal will investigate whether alternative therapies can be developed by modulating specific physiologic mechanisms of ventilatory control. Specifically, the investigators will study whether interventions with sustained hyperoxia (Aim 1), finasteride (Aim 2) and acetazolamide (Aim 3) will reduce breathing instability during sleep by reducing chemoresponsiveness and/or increasing cerebrovascular reactivity (CVR) in order to alleviate sleep disordered breathing in the elderly with sleep apnea. The proposed aims will also allow us to delineate key mechanisms of breathing instability in the elderly. The investigators envision that the results obtained from this project will ultimately allow us to develop novel alternative therapies for sleep apnea in the elderly. We will also compare CVR in young vs older adults

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

Secondary outcomes

  1. Apnea hypopnea index

    Time frame: 2 days to 30 days

    Apnea hypopnea index- is a measure of severity of sleep apnea - this is calculated as the total number of apneas and hypopneas recorded during a sleep study divided by the total sleep time during the sleep study.

Study contacts

Contact information is provided by the study sponsor or research team.

Ruchi Rastogi, MS

CONTACT

[email protected]

(313) 576-4464

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Pathophysiology-Guided Therapy for Sleep Apnea in the Elderly

Important dates

Study start
2015
Primary completion
2026
Study completion
2026
First posted
Mar 9, 2016
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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