Evaluating the Effect of a Sleep Prehabilitation Intervention: a Single-blind Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 154
- 试验地点
- 2
- 主要终点
- The Pittsburgh Sleep Quality Index (PSQI)
研究概览
简要总结
The goal of this clinical trial is to learn if changing sleep behaviour can improve sleep health in patients undergoing prehabilitation before elective surgery. Prehabilitation is the use of exercise, nutrition, and psychological support before surgery to improve recovery from surgery.
The main questions it aims to answer are:
Does changing sleep behaviour improve sleep before surgery? Does changing sleep behaviour improve recovery after surgery?
Researchers will compare participants who receive sleep support with participants who do not receive sleep support to see if it improves sleep health and recovery from surgery.
Participants will be asked to attend 4 meetings with the research team to learn how they can improve their sleep. They will use questionnaires, a diary, and a wearable tracker to record their sleep.
详细描述
Sample Size: N = 154
Study Population: Patients participating in UHN's Prehabilitation Program. Participants will be excluded if they are participating in prehabilitation entirely remotely (i.e., no in-person visits), have an existing sleep disorder, are a shift worker, have travel plans outside of usual time zone, or have a cognitive disability that limits answering questionnaires or adhering to the intervention.
Study Design: Randomized trial with outcome assessors blinded to group allocation.
Primary Objective: Measure the effect of a personalized sleep prehabilitation (PSP) in addition to standard of care prehabilitation on participant sleep health compared to standard of care prehabilitation alone.
Secondary Objective: To measure the effect of the PSP versus standard of care prehabilitation on other outcomes including clinical outcomes, patient-reported outcomes, and physical fitness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •surgery date (or expected date) is ≥ 4 weeks and ≤ 12 weeks year from the time of consent
- •currently sleep < 7 hours of sleep on most nights in the past month
- •consistently have a sleep latency > 30 minutes
- •consistently wake up throughout the night
- •consistently wake up earlier than intended
- •experience daytime sleepiness
排除标准
- •have an existing diagnosed sleep disorder that is poorly managed or requires referral to a sleep clinician
- •are currently a shift worker (work schedule outside of 7am-6pm).
- •have plans to travel 3 or more hours outside of their usual time zone
- •do not have English proficiency
- •have a cognitive disability that significantly limits ability to respond to screening questions as this will impact ability to answer questionnaires and adhere to the intervention (if applicable)
结局指标
主要结局
The Pittsburgh Sleep Quality Index (PSQI)
时间窗: Administered baseline, one week before surgery, and 45 days after surgery
The PSQI is a self-report measure of sleep quality among seven subscales including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleep medication, and daytime dysfunction. The scale's validity and reliability has been determined among clinical and older adult populations. For reporting, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (min: 0 and max: 21). Higher scores indicate worse sleep quality. Time to completion is 5-10 minutes.
次要结局
- Sleep self-efficacy scale(Baseline, 1 week presurgery, 45 days after surgery.)
- Sleep diary - Sleep duration(Baseline, presurgery, 45 days after surgery)
- Sleep diary - Sleep efficiency(Baseline, presurgery, 45 days after surgery)
- Sleep diary - Sleep latency(Baseline, presurgery, 45 days after surgery)
- Sleep diary - Sleep quality(Baseline, presurgery, 45 days after surgery)
- Wrist-worn actigraphy - Sleep duration(Baseline, presurgery, 45 days after surgery)
- Wrist-worn actigraphy - Sleep latency(Baseline, presurgery, 45 days after surgery)
- Wrist-worn actigraphy - Sleep efficiency(Baseline, presurgery, 45 days after surgery)
- Wrist-worn actigraphy - Resting heart rate(Baseline, presurgery, 45 days after surgery)
- Wrist-worn actigraphy - Heart rate variability(Baseline, presurgery, 45 days after surgery)
- Wrist-worn actigraphy - Light intensity physical activity(Baseline, presurgery, 45 days after surgery)
- Wrist-worn actigraphy - Moderate-vigorous physical activity(Baseline, presurgery, 45 days after surgery)
- Physical Fitness - Body mass index(Baseline, presurgery, 45 days after surgery)
- Physical Fitness - Body fat %(Baseline, presurgery, 45 days after surgery)
- Physical Fitness - Grip strength(Baseline, presurgery, 45 days after surgery)
- Physical Fitness - Six minute walk test(Baseline, presurgery, 45 days after surgery)
- Surgical complications(Up to 45 days after surgery)
- Hospital length of stay(Up to 45 days after surgery)
- Discharge destination(Up to 45 days after surgery)
- Readmission to the hospital(Up to 45 days after surgery)
- PROMIS 29+2(Baseline, presurgery, 45 days after surgery)