Actively Recruiting
Efficacy of Suvorexant on Post-operative Sleep Disturbance
Led by Columbia University · Updated on 2024-05-22
92
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 (e.g., 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.
CONDITIONS
Official Title
Efficacy of Suvorexant on Post-operative Sleep Disturbance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 50 years to 90 years old.
- Scheduled for elective orthopedic, abdominal, urologic, gynecologic, or spine surgery with a planned hospital stay of at least 24 hours.
- Experiencing insomnia with trouble falling asleep, early morning awakening, or difficulty maintaining sleep three or more times per week for at least three months.
You will not qualify if you...
- Patients admitted to intensive care after surgery.
- Undergoing coronary artery bypass graft or other cardiac surgeries.
- Having intra-cranial surgery.
- Taking more than 60 mg oxycodone or equivalent as outpatient.
- Having circadian rhythm disorders.
- High scores on the Geriatric Depression Scale.
- Moderate to severe dementia (failed t-MoCa test).
- Severe obstructive sleep apnea (Apnea-hypopnea index over 30 or high risk on screening).
- Using Cytochrome P-450 inhibitors or inducers (such as clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole, ritonavir, verapamil, goldenseal, grapefruit, phenobarbital, phenytoin, rifampicin, St. John's Wort, or glucocorticoids).
- Vulnerable populations including children and pregnant women.
AI-Screening
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Trial Site Locations
Total: 1 location
1
NewYork-Presbyterian Allen Hospital/CUMC Milstein Hospital Building
New York, New York, United States, 10032/10034
Actively Recruiting
Research Team
P
Paul S. Garcia, MD PhD
CONTACT
O
Oriana Lujan, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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