NCT05823844 Efficacy of Suvorexant on Post-operative Sleep Disturbance
| NCT ID | NCT05823844 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Columbia University |
| Condition | Postoperative Insomnia |
| Study Type | INTERVENTIONAL |
| Enrollment | 92 participants |
| Start Date | 2023-05-01 |
| Primary Completion | 2025-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 92 participants in total. It began in 2023-05-01 with a primary completion date of 2025-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 (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 Criteria
Inclusion criteria: * 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. Exclusion criteria: * Patients who undergo surgery and then are admitted to intensive care. * Coronary artery bypass graft (CABG) or other cardiac surgeries. * Intra-cranial surgery. * Patients taking more than 60 mg of oxycodone or it's equivalent as outpatient * Circadian rhythm disorders. * High score in the Geriatric Depression Scale (GDS) * Moderate to severe dementia (failed t-MoCa) * Severe obstructive sleep apnea (OSA) (Apnea-hypopnea index (AHI)\>30 and/or screen high risk) * Patients receiving Cytochrome P-450 (CYP3) inhibitors or inducers (Inhibitors: clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole, ritonavir, verapamil, goldenseal, and grapefruit. Inducers: phenobarbital, phenytoin, rifampicin, St. John's Wort, and glucocorticoids). * Vulnerable populations (i.e., children, pregnant women).
Contact & Investigator
Paul S. Garcia, MD PhD
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT05823844 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 90 Years, studying Postoperative Insomnia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05823844 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05823844 currently recruiting?
Yes, NCT05823844 is actively recruiting participants. Contact the research team at pg2618@cumc.columbia.edu for enrollment information.
Where is the NCT05823844 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT05823844 clinical trial?
NCT05823844 is sponsored by Columbia University. The principal investigator is Paul S. Garcia, MD PhD at Columbia University. The trial plans to enroll 92 participants.
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