Using Suvorexant to Improve Sleep After Surgery
Improvement of Restorative Sleep and Post-surgical Insomnia Following Suvorexant Administration
This study is testing if a sleep medication called Suvorexant can help people sleep better after having surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 50 Years to 90 Years |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05823844 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of Suvorexant in improving sleep quality for patients recovering from elective surgeries. It is a double-blind, randomized study involving 92 participants who will be divided into two groups: one receiving Suvorexant and the other receiving a placebo. The treatment will begin on the first night after surgery and continue throughout the hospital stay, with sleep patterns monitored using a wearable EEG device. The goal is to assess whether Suvorexant can enhance sleep quality and, consequently, patient outcomes during hospitalization.
Who should consider this trial
Good fit: Ideal candidates are adults aged 50 to 90 undergoing elective surgeries with a projected hospital stay of 24 hours or longer and experiencing insomnia.
Not a fit: Patients undergoing intensive care, cardiac surgeries, or those with severe sleep disorders or cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve sleep quality for postoperative patients, leading to better recovery outcomes.
How similar studies have performed: Previous studies have shown that Suvorexant is effective in treating insomnia in outpatient settings, suggesting potential for success in this novel inpatient application.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
New York, New York
- NewYork-Presbyterian Allen Hospital/CUMC Milstein Hospital Building — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Paul S. Garcia, MD PhD — Columbia University
- Study coordinator: Paul S. Garcia, MD PhD
- Email: pg2618@cumc.columbia.edu
- Phone: 212-304-7523
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.