Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06286189
Status:
RECRUITING
Last Update Posted:
2024-02-29
First Post:
2024-02-22
Brief Title:
Trazodone on OSA Endotypes
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Effect of Trazodone on Obstructive Sleep Apnea Endotypes and Severity
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None