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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.
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.
Endpoints of the study: Self-reported sleep health via the Pittsburgh Sleep Quality Index (PSQI; primary outcome). Other sleep health outcomes include the insomnia severity scale (ISI), STOP-BANG questionnaire, Restless Leg Syndrome Diagnostic Index, sleep diary, Global Sleep Assessment Questionnaire (GSAQ), and sleep self-efficacy scale. Clinical outcomes include hospital length of stay and surgical complications. Anthropometric and physical fitness outcomes include: body mass index, bioelectrical impedance analysis (lean mass and fat mass), waist circumference, muscular fitness, aerobic fitness, and functional capacity. Device measured outcomes include sleep, physical activity, resting heart rate, and heart rate variability via a wrist-worn activity tracker.
Analysis: Descriptive statistics will be used to characterize participant characteristics. The primary analysis will be an ANCOVA to detect significant differences in PSQI between groups at the preoperative timepoint while controlling for baseline scores. The secondary analysis will be a linear mixed effect model to derive point estimates for effectiveness markers (primary and secondary) at each timepoint, comparing between- and within- group differences at each timepoint. Means and 95% CI will be reported.
Impact: The proposed study will be the first to explore the effect of a PSP in addition to standard-of-care prehabilitation service on sleep health.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care Prehabilitation | Active Comparator | Prehabilitation at UHN's Prehabilitation Program includes assessment of patients' function followed by individualized health optimizing intervention including: exercise, nutritional support, psychosocial support, education, smoking cessation support, and/or medical care. |
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| Personalized Sleep Prehabilitation | Experimental | Sleep prehabilitation will consist of usual care prehabilitation (exercise, nutritional support, psychosocial support, education, smoking cessation support, and/or medical care) with the addition of sleep support. This support will consist of:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Personalized Sleep Prehabilitation (PSP) | Behavioral | Sleep prehabilitation will consist of usual care prehabilitation (exercise, nutritional support, psychosocial support, education, smoking cessation support, and/or medical care) with the addition of sleep support. This support will consist of:
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| Measure | Description | Time Frame |
|---|---|---|
| The Pittsburgh Sleep Quality Index (PSQI) | 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. | Administered baseline, one week before surgery, and 45 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep self-efficacy scale | Self reported questionnaire measuring confidence in one's ability to change sleep behaviour. This scale contains 13 items scored 1-5 (min: 13, max: 65). Greater scores indicate more sleep self-efficacy. | Baseline, 1 week presurgery, 45 days after surgery. |
| Sleep diary - Sleep duration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel Santa Mina, PhD | Contact | 416-978-1696 | daniel.santamina@uhn.ca | |
| Ian Randall, MD | Contact | (416) 340-5164 | ian.randall@uhn.ca |
| Name | Affiliation | Role |
|---|---|---|
| Daniel Santa Mina, PhD | University Health Network, Toronto | Principal Investigator |
| Ian Randall, MD | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Health Network | Recruiting | Toronto | Ontario | M5G 2C4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40884156 | Derived | Sibley D, Randall I, Culos-Reed SN, Slepian PM, Singh M, Mina DS. Evaluating the Effect of a Sleep Prehabilitation Intervention in Patients Awaiting Elective Surgery: Protocol for a Single-Blind Randomised Trial. J Sleep Res. 2026 Apr;35(2):e70173. doi: 10.1111/jsr.70173. Epub 2025 Aug 30. |
| Label | URL |
|---|---|
| Prehabilitation Program | View source |
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IPD that underlie results in a publication
Study protocol may be shared with publication. All other data available on reasonable request.
Stakeholders may access the data upon reasonable request. Mechanism and agreement of access will be determined at the time of the request.
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| Standard of Care Prehabilitation | Behavioral | Exercise, nutritional support, psychosocial support, education, smoking cessation support, and/or medical care delivered by regulated health professionals included Kinesiologists, Dietitians, Clinical Psychologists, etc. |
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Self-reported by the participant in the sleep diary each day for 1 week. |
| Baseline, presurgery, 45 days after surgery |
| Sleep diary - Sleep efficiency | Time in bed and sleep duration are self-reported by the participant in the sleep diary each day for 1 week. Sleep efficiency is calculated as sleep duration/time in bed and expressed as a percentage. | Baseline, presurgery, 45 days after surgery |
| Sleep diary - Sleep latency | Self-reported by the participant in the sleep diary each day for 1 week. | Baseline, presurgery, 45 days after surgery |
| Sleep diary - Sleep quality | Self-reported by the participant in the sleep diary each day for 1 week using a 5-pt Likert scale ranging from "Very poor" to "Very good" (scored 0-4). Higher scores indicate better quality sleep. | Baseline, presurgery, 45 days after surgery |
| Wrist-worn actigraphy - Sleep duration | All participants will be provided with a Fitbit Inspire 3, a small non-intrusive and waterproof device that uses actigraphy to measure orientation and movement and uses photoplethysmography (PPG) to detect periodic changes in blood flow beneath the sensor; thereby measuring changes in heart rate. This device is worn like a wrist-watch. The activity tracker measures sleep-wake activity to measure sleep duration expressed in minutes. | Baseline, presurgery, 45 days after surgery |
| Wrist-worn actigraphy - Sleep latency | All participants will be provided with a Fitbit Inspire 3, a small non-intrusive and waterproof device that uses actigraphy to measure orientation and movement and uses photoplethysmography (PPG) to detect periodic changes in blood flow beneath the sensor; thereby measuring changes in heart rate. This device is worn like a wrist-watch. The activity tracker measures sleep-wake activity to measure sleep latency expressed in minutes. | Baseline, presurgery, 45 days after surgery |
| Wrist-worn actigraphy - Sleep efficiency | All participants will be provided with a Fitbit Inspire 3, a small non-intrusive and waterproof device that uses actigraphy to measure orientation and movement and uses photoplethysmography (PPG) to detect periodic changes in blood flow beneath the sensor; thereby measuring changes in heart rate. This device is worn like a wrist-watch. The activity tracker measures sleep-wake activity to measure time in bed and time spent sleeping to compute sleep efficiency expressed as a percentage. | Baseline, presurgery, 45 days after surgery |
| Wrist-worn actigraphy - Resting heart rate | All participants will be provided with a Fitbit Inspire 3, a small non-intrusive and waterproof device that uses actigraphy to measure orientation and movement and uses photoplethysmography (PPG) to detect periodic changes in blood flow beneath the sensor; thereby measuring changes in heart rate. This device is worn like a wrist-watch. The heart rate monitor will measure resting heart rate (bpm) a metric of overall fitness and autonomic nervous system function. Participants will be provided with setup instructions at their baseline appointment and receive ongoing support for the use of their tracker. | Baseline, presurgery, 45 days after surgery |
| Wrist-worn actigraphy - Heart rate variability | All participants will be provided with a Fitbit Inspire 3, a small non-intrusive and waterproof device that uses actigraphy to measure orientation and movement and uses photoplethysmography (PPG) to detect periodic changes in blood flow beneath the sensor; thereby measuring changes in heart rate. This device is worn like a wrist-watch. The heart rate monitor will measure heart rate variability, a metric of overall fitness and autonomic nervous system function. Participants will be provided with setup instructions at their baseline appointment and receive ongoing support for the use of their tracker. | Baseline, presurgery, 45 days after surgery |
| Wrist-worn actigraphy - Light intensity physical activity | All participants will be provided with a Fitbit Inspire 3, a small non-intrusive and waterproof device that uses actigraphy to measure orientation and movement and uses photoplethysmography (PPG) to detect periodic changes in blood flow beneath the sensor; thereby measuring changes in heart rate. This device is worn like a wrist-watch. The actigraphy will measure light intensity physical activity reported in minutes. | Baseline, presurgery, 45 days after surgery |
| Wrist-worn actigraphy - Moderate-vigorous physical activity | All participants will be provided with a Fitbit Inspire 3, a small non-intrusive and waterproof device that uses actigraphy to measure orientation and movement and uses photoplethysmography (PPG) to detect periodic changes in blood flow beneath the sensor; thereby measuring changes in heart rate. This device is worn like a wrist-watch. The actigraphy will measure moderate-vigorous intensity physical activity reported in minutes. | Baseline, presurgery, 45 days after surgery |
| Physical Fitness - Body mass index | A kinesiologist will measure height and weight to calculate body mass index expressed in in kg/m^2 | Baseline, presurgery, 45 days after surgery |
| Physical Fitness - Body fat % | A kinesiologist will measure body fat percentage with a mBCA 514 (Seca, Hamburg, Germany) | Baseline, presurgery, 45 days after surgery |
| Physical Fitness - Grip strength | A kinesiologist will measure grip strength using a handgrip dynamometer | Baseline, presurgery, 45 days after surgery |
| Physical Fitness - Six minute walk test | A kinesiologist will measure aerobic fitness using a six-minute walk test on a 60m track. | Baseline, presurgery, 45 days after surgery |
| Surgical complications | Surgical complications will be extracted from participant medical records. | Up to 45 days after surgery |
| Hospital length of stay | Hospital length of stay will be extracted from participant medical records. | Up to 45 days after surgery |
| Discharge destination | Discharge destination will be extracted from participant medical records. | Up to 45 days after surgery |
| Readmission to the hospital | Readmissions will be extracted from participant medical records | Up to 45 days after surgery |
| PROMIS 29+2 | The Patient-Reported Outcomes Measurement Information System (PROMIS) is a set of person-centred measures that evaluates physical, mental, and social health. The PROMIS 29+2 Profile v2.1 (PROPr) will be administered. The PROMIS instruments have been used and validated extensively in clinical There are 31 questions answered using a Likert scale from 1-5. Each domain (physical function, anxiety, depression, cognitive function, sleep disturbance, fatigue, social activity, and pain) has 2-4 items. Higher score is more of that concept. Raw scores are converted into T scores. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Time to completion: 5-10 minutes | Baseline, presurgery, 45 days after surgery |