Clinical trial NCT05823844: Efficacy of Suvorexant on Post-operative Sleep Disturbance
Official title: Improvement of Restorative Sleep and Post-surgical Insomnia Following Suvorexant Administration
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Postoperative Insomnia
Postoperative Delirium
Keywords: Sleep Disturbance
Insomnia
Sleep quality
Suvorexant
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2023-04-21
Enrollment: 92
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: It is rare to get a good night's sleep in the hospital. Even routine patient care, including alarm systems, and too much light can lead to sleep disturbance. Failure to achieve enough high-quality sleep has been associated with decreased brain and heart function. The investigators aim to restore usual sleep patterns in hospitalized patients to have a positive influence on patient outcomes and healthcare costs. Suvorexant, the tested drug in our protocol, works on a different brain chemical system than most other sleep drugs, which may account for its ability to restore natural sleep. Suvorexant has been shown to reduce wakefulness during sleep by a reduction in long wake bouts. This reduction has a positive effect on sleep quality. In keeping with Suvorexant's established ability to decrease insomnia in outpatient settings, the investigators will assess its efficacy to improve sleep quality in the hospital environment in patients having surgery who have sleep disturbance. Suvorexant will be administered beginning on the night after surgery and through the hospitalization (it is estimated that stays will be 1-3 days; the investigators will set a maximum of 4 days). If the dose is not well tolerated (e.g., daytime sleepiness), then the dose may be decreased to 10 mg of Suvorexant. The investigators aim to study the participant's sleep patterns by using a self-wearable electroencephalography (EEG) recording device, the Sleep Profiler, and see patterns such as total sleep time or the stages of sleep such as rapid eye movement (REM), non-REM, etc. Additionally, the investigators hope to determine if concentration, attention, and general cognitive performance are improved as a result of better sleep. Promoting "natural sleep" may improve surgical recovery through the lessening of fatigue and improvements in brain health.

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).

Primary outcomes:
measure: Total sleep time on day 0 (TST)
timeFrame: Day 0 of in-hospital stay after surgery
Secondary outcomes:
measure: Longitudinal trend of TST
timeFrame: Up to Day 5 post-surgery
measure: Rate of attrition
timeFrame: Up to Day 5 post-surgery
measure: Richards Campbell Self-Report Sleep Scale
timeFrame: Up to Day 5 post-surgery
measure: Incidence of Delirium
timeFrame: Up to Day 5 post-surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: NewYork-Presbyterian Allen Hospital/CUMC Milstein Hospital Building
state: New York
Study officials:
affiliation: Columbia University
name: Paul S. Garcia, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: