Sleep Apnea in Elderly

Part of paid clinical trials in Detroit, Michigan.

Sponsor
VA Office of Research and Development
Study ID
NCT02703220
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - 89 Years
Healthy Volunteers
Accepted

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
  • 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).

Study Details

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.

Key Dates

Start date
Jul 3, 2015
Status verified
Sep 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

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.

Primary Outcome Measure

Apneic threshold- a measure of breathing instability [ Time Frame: 2 days to 30 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
John D. Dingell VA Medical Center, Detroit, MIDetroitMichigan48201-1916
Lynn M Huber
[email protected]
313-576-3106
Susmita Chowdhuri, MD MS (PRINCIPAL_INVESTIGATOR)

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By research site
John D. Dingell VA Medical Center, Detroit, MI· Detroit, MI

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