Sleep Apnea in Elderly

NCT02703220 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: PULM-008-14F
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Apneic threshold- a measure of breathing instability

  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 days to 30 days

• Cerebrovascular responsiveness to carbon-dioxide

  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

  7 days

• Ventilatory responsiveness

  Hypocapnic ventilatory response; this is calculated as the change in minute ventilation for corresponding changes in PETCO2.

  2 days to 30 days

• Carbon -dioxide reserve

  This is a derived measure. This is calculated as the difference between the apneic threshold PETCO2 (given above) and the control PETCO2.

  2 days to 30 days

Secondary Outcomes (1)

• Apnea hypopnea index

  2 days to 30 days

Study Arms (3)

Hyperoxia

EXPERIMENTAL

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.

Other: Hyperoxia/oxygen

Acetazolamide (ACZ)

EXPERIMENTAL

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.

Drug: Acetazolamide

Finasteride

EXPERIMENTAL

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

Drug: Finasteride

Interventions

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

Hyperoxia

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.

Acetazolamide (ACZ)

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).

Finasteride

Eligibility Criteria

• Age: 60 Years - 89 Years
• Gender Eligibility Details: The Finasteride arm of the study is only applicable for male gender.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

John D. Dingell VA Medical Center, Detroit, MI

Detroit, Michigan, 48201-1916, United States

RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes; Hyperoxia

Interventions

Oxygen; Acetazolamide; Finasteride

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases; Thiadiazoles; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Azasteroids; Steroids, Heterocyclic

Study Officials

• Susmita Chowdhuri, MD MS

  John D. Dingell VA Medical Center, Detroit, MI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruchi Rastogi, MS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2016
• First Posted: March 9, 2016
• Study Start: July 3, 2015
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)