Improvement of Restorative Sleep and Post-surgical Insomnia Following Suvorexant Administration
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Total sleep time on day 0 (TST)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
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).
干预措施: Suvorexant (Drug)
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 4 days).
干预措施: Placebo (Drug)
结局指标
主要结局
Total sleep time on day 0 (TST)
时间窗: Day 0 of in-hospital stay after surgery
Analysis will be adjusted for group baseline differences, including pre-existing cognitive impairment, medical co-morbidities, and the type and duration of surgery.
Total Sleep Time on Day 0 (TST)
时间窗: Day 0 of in-hospital stay after surgery
次要结局
- 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)
- Longitudinal Trend of TST(Up to Day 4 post-surgery)
- Rate of Attrition(Up to Day 4 post-surgery)
- Richards Campbell Self-Report Sleep Scale(Up to Day 4 post-surgery)
- Number of Participants With Incidence of Delirium(Up to Day 4 post-surgery)
- Sleep Rescue Medication(Enrollment to end of hospital stay)
研究者
Paul Garcia
Associate Professor of Anesthesiology
Columbia University