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Improvement of Restorative Sleep and Post-surgical Insomnia Following Suvorexant Administration

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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 (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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 90
Healthy Volunteers: f
View:

• Aged 50 years to 90 years old.

• Patients getting elective surgeries for orthopedic reasons (e.g., hip or knee replacement), abdominal surgery (e.g., hernia repair, renal cancer), urologic or gynecologic surgery, and spine surgery with a projected inpatient stay of 24 hours or longer.

• Patients experiencing insomnia characterized by difficulties with sleep onset, early morning awakening, and/or sleep maintenance three or more times weekly over a three-month period for eligibility.

Locations
United States
New York
NewYork-Presbyterian Allen Hospital/CUMC Milstein Hospital Building
RECRUITING
New York
Contact Information
Primary
Paul S. Garcia, MD PhD
pg2618@cumc.columbia.edu
212-304-7523
Backup
Oriana Lujan, MD
ol2274@cumc.columbia.edu
212-3047523
Time Frame
Start Date: 2023-05-01
Estimated Completion Date: 2025-05
Participants
Target number of participants: 92
Treatments
Experimental: Suvorexant administration
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). Suvorexant will be administered beginning on the night after surgery and through the hospitalization period (it is estimated that stays will be 1-3 days; subjects will be followed for a maximum of 5 days).
Placebo_comparator: Placebo administration
Subjects will receive a placebo (two tablets) and treatment as usual. The placebo will be administered beginning on the night after surgery and through the hospitalization period (it is estimated that stays will be 1-3 days; subjects will be followed for a maximum of 5 days).
Related Therapeutic Areas
Sponsors
Leads: Columbia University
Collaborators: Merck Sharp & Dohme LLC

This content was sourced from clinicaltrials.gov