Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05823844
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2023-04-10
Brief Title:
Efficacy of Suvorexant on Post-operative Sleep Disturbance
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Improvement of Restorative Sleep and Post-surgical Insomnia Following Suvorexant Administration
Status:
RECRUITING
Status Verified Date:
2024-05
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:
The study is a parallel group double blind randomized trial Subjects will be recruited from individuals undergoing elective surgery for orthopedic abdominal urologic gynecologic or spine reasons Out of 92 subjects one experimental group of 46 subjects will receive 20 mg Suvorexant beginning the first in-hospital night day 0 and continuing for their hospital stay If the dose is not well tolerated eg daytime sleepiness then the dose may be decreased to 10 mg of Suvorexant
For blinding purposes each arm will receive two tablets two 10 mg tablets or one 10 mg tablet and a placebo The other control group of 46 subjects will receive placebo two tablets and treatment as usual
For blinding purposes each arm will receive two tablets two 10 mg tablets or one 10 mg tablet and a placebo The other control group of 46 subjects will receive placebo two tablets and treatment as usual
Detailed Description:
It is rare to get a good nights sleep in the hospital Even routine patient care including alarm systems and too much light can lead to sleep disturbance Failure to achieve enough high-quality sleep has been associated with decreased brain and heart function The investigators aim to restore usual sleep patterns in hospitalized patients to have a positive influence on patient outcomes and healthcare costs Suvorexant the tested drug in our protocol works on a different brain chemical system than most other sleep drugs which may account for its ability to restore natural sleep Suvorexant has been shown to reduce wakefulness during sleep by a reduction in long wake bouts This reduction has a positive effect on sleep quality In keeping with Suvorexants established ability to decrease insomnia in outpatient settings the investigators will assess its efficacy to improve sleep quality in the hospital environment in patients having surgery who have sleep disturbance Suvorexant will be administered beginning on the night after surgery and through the hospitalization it is estimated that stays will be 1-3 days the investigators will set a maximum of 4 days If the dose is not well tolerated eg daytime sleepiness then the dose may be decreased to 10 mg of Suvorexant The investigators aim to study the participants sleep patterns by using a self-wearable electroencephalography EEG recording device the Sleep Profiler and see patterns such as total sleep time or the stages of sleep such as rapid eye movement REM non-REM etc Additionally the investigators hope to determine if concentration attention and general cognitive performance are improved as a result of better sleep Promoting natural sleep may improve surgical recovery through the lessening of fatigue and improvements in brain health
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?:
True
Is an FDA AA801 Violation?:
None