Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Location status: Recruiting
NCT Number: NCT06286189
Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. Some OSA patients with low arousal threshold wake up prematurely during an obstructive event and do not have time for spontaneous upper airway (UA) dilator muscle recruitment. As a consequence they are exposed to apnea and hypopnea cycling. In this protocol the investigators will test the effect of trazodone administered before sleep on OSA traits and OSA severity during sleep.
Interested in participating?
Request Info21 year–70 year
All sexes
Interventional
Phase 1 / Phase 2
Boston, Massachusetts, 02115, United States
Location status: Recruiting
Two overnight home sleep studies will be performed: a drug night and a placebo night. The patient will breath spontaneously (without CPAP) for both nights. On the study nights, subjects be instrumented with a full polygraphy for monitoring sleep, and respiratory events. Trazodone 100 mg will be given 30 min before lights out. At least four hours of sleep with high quality signal acquisition will be required for a study to be judged adequate. After the first overnight study is completed, there will be a one-week washout period prior to crossing over to the other treatment.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Placebo capsule taken 30 min before sleep
Trazodone 100 mg 30 min before sleep
Time frame: 1 night
Arousal threshold will be calculated non invasively from the home sleep test flow signal
Time frame: 1 night
Apnea hypopnea index will be calculated from the home sleep test
Contact information is provided by the study sponsor or research team.
Brigham and Women's Hospital
Other
Effect of Trazodone on Obstructive Sleep Apnea Endotypes and Severity
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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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