Sleep Apnea in Elderly
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|ClinicalTrials.gov Identifier: NCT02703220|
Recruitment Status : Recruiting
First Posted : March 9, 2016
Last Update Posted : April 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea Elderly Adults||Other: Hyperoxia/oxygen Drug: Acetazolamide Drug: Finasteride||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Pathophysiology-Guided Therapy for Sleep Apnea in the Elderly|
|Actual Study Start Date :||July 3, 2015|
|Estimated Primary Completion Date :||December 2, 2019|
|Estimated Study Completion Date :||December 30, 2019|
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.
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
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.
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.
Determine the effect of oral finasteride therapy vs placebo for 1 month on SDB and the AT and chemosensitivity during NREM sleep.
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).
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02703220
|Contact: Ruchi Rastogi, MSc||(313) firstname.lastname@example.org|
|United States, Michigan|
|John D. Dingell VA Medical Center, Detroit, MI||Recruiting|
|Detroit, Michigan, United States, 48201|
|Contact: Erin Olgren, PhD MS 313-576-4448 email@example.com|
|Principal Investigator: Susmita Chowdhuri, MD|
|Principal Investigator:||Susmita Chowdhuri, MD||John D. Dingell VA Medical Center, Detroit, MI|