Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2025-12-17 @ 5:03 PM
Study NCT ID:
NCT06286189
Status:
None
Last Update Posted:
2025-02-06 00:00:00
First Post:
2024-02-22 00:00:00
Brief Title:
Trazodone on OSA Endotypes
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Women's Hospital
Study Overview
Official Title:
Effect of Trazodone on Obstructive Sleep Apnea Endotypes and Severity
Status:
None
Status Verified Date:
2025-02
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:
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.
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