Efficacy of Suvorexant on Post-operative Sleep Disturbance

NCT05823844 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: AAAU4343
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Insomnia; Postoperative Delirium

Keywords

Sleep Disturbance; Insomnia; Sleep quality; Suvorexant

Outcome Measures

Primary Outcomes (1)

• Total sleep time on day 0 (TST)

  Analysis will be adjusted for group baseline differences, including pre-existing cognitive impairment, medical co-morbidities, and the type and duration of surgery.

  Day 0 of in-hospital stay after surgery

Secondary Outcomes (4)

• Longitudinal trend of TST

  Up to Day 5 post-surgery

• Rate of attrition

  Up to Day 5 post-surgery

• Richards Campbell Self-Report Sleep Scale

  Up to Day 5 post-surgery

• Incidence of Delirium

  Up to Day 5 post-surgery

Study Arms (2)

Suvorexant administration

EXPERIMENTAL

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).

Drug: Suvorexant

Placebo administration

PLACEBO COMPARATOR

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).

Drug: Placebo

Interventions

Suvorexant DRUG

Suvorexant (Belsomra™) is an orexin receptor antagonist that will be administered as 2 tablets (10mg each) for a starting dose of 20mg. If the dose is not well tolerated (e.g., daytime sleepiness), then the dose may be decreased to 10 mg of Suvorexant.

Also known as: Belsomra

Suvorexant administration

Placebo DRUG

The placebo pill will look identical to Suvorexant and will be taken as 2 tablets.

Placebo administration

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Columbia University: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

NewYork-Presbyterian Allen Hospital/CUMC Milstein Hospital Building

New York, New York, 10032/10034, United States

RECRUITING

MeSH Terms

Conditions

Emergence Delirium; Parasomnias; Sleep Initiation and Maintenance Disorders

Interventions

suvorexant

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Paul S. Garcia, MD PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul S. Garcia, MD PhD

CONTACT

212-304-7523; pg2618@cumc.columbia.edu

Oriana Lujan, MD

CONTACT

212-3047523; ol2274@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Raters and subjects will be blinded to treatment. At the study's completion (the last subject completes) the blind will be broken, and data will be turned over for analysis. A study physician will be available on call 24 hours to monitor patient safety issues that may arise during the hospitalization and they will have access to the blind. Furthermore, the Research Pharmacy will maintain the blind.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Model Details: This study is a parallel-group, double-blind, randomized trial where 92 subjects will to randomized 1:1 to either receive 20 mg Suvorexant or placebo (two tablets) and treatment as usual.

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: April 21, 2023
• Study Start: May 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)