Sleep Apnea in Elderly

NCT ID: NCT02703220

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-03
• Study Completion Date: 2026-07-31

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.

Detailed Description

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

Conditions

Sleep Apnea; Elderly Adults

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Hyperoxia/oxygen

Intervention Type: 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 (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.

Group Type: EXPERIMENTAL

Acetazolamide

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Finasteride

Intervention Type: 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).

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

Intervention Type: OTHER

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.

Intervention Type: 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).

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susmita Chowdhuri, MD MS

Role: PRINCIPAL_INVESTIGATOR

John D. Dingell VA Medical Center, Detroit, MI

Locations

John D. Dingell VA Medical Center, Detroit, MI

Detroit, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ruchi Rastogi, MS

Role: CONTACT

ruchi.rastogi@va.gov

(313) 576-4464

Facility Contacts

Lynn M Huber

Role: primary

lynn.huber@va.gov

313-576-3106

Other Identifiers

PULM-008-14F

Identifier Type: -

Identifier Source: org_study_id