NCT Number: NCT06762639
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Toronto, Ontario, M5G 2C4, Canada
Location status: Recruiting
Clinical Coordinator, MSc
CONTACT
416-340-4800 ext. 416 340 4645
Daniel Sibley, MSc
SUB_INVESTIGATOR
Mandeep Singh, MD
SUB_INVESTIGATOR
Max Slepian, PhD
SUB_INVESTIGATOR
Research Manager, RN
CONTACT
416-340-4800 ext. 2927
S.Nicole Culos-Reed, PhD
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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:
Exercise, nutritional support, psychosocial support, education, smoking cessation support, and/or medical care delivered by regulated health professionals included Kinesiologists, Dietitians, Clinical Psychologists, etc.
Time frame: 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.
Time frame: Baseline, 1 week presurgery, 45 days after surgery.
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.
Time frame: Baseline, presurgery, 45 days after surgery
Self-reported by the participant in the sleep diary each day for 1 week.
Time frame: Baseline, presurgery, 45 days after surgery
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.
Time frame: Baseline, presurgery, 45 days after surgery
Self-reported by the participant in the sleep diary each day for 1 week.
Time frame: Baseline, presurgery, 45 days after surgery
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.
Time frame: Baseline, presurgery, 45 days after surgery
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.
Time frame: Baseline, presurgery, 45 days after surgery
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.
Time frame: Baseline, presurgery, 45 days after surgery
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.
Time frame: Baseline, presurgery, 45 days after surgery
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.
Time frame: Baseline, presurgery, 45 days after surgery
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.
Time frame: Baseline, presurgery, 45 days after surgery
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.
Time frame: Baseline, presurgery, 45 days after surgery
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.
Time frame: Baseline, presurgery, 45 days after surgery
A kinesiologist will measure height and weight to calculate body mass index expressed in in kg/m^2
Time frame: Baseline, presurgery, 45 days after surgery
A kinesiologist will measure body fat percentage with a mBCA 514 (Seca, Hamburg, Germany)
Time frame: Baseline, presurgery, 45 days after surgery
A kinesiologist will measure grip strength using a handgrip dynamometer
Time frame: Baseline, presurgery, 45 days after surgery
A kinesiologist will measure aerobic fitness using a six-minute walk test on a 60m track.
Time frame: Up to 45 days after surgery
Surgical complications will be extracted from participant medical records.
Time frame: Up to 45 days after surgery
Hospital length of stay will be extracted from participant medical records.
Time frame: Up to 45 days after surgery
Discharge destination will be extracted from participant medical records.
Time frame: Up to 45 days after surgery
Readmissions will be extracted from participant medical records
Time frame: Baseline, presurgery, 45 days after surgery
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
Contact information is provided by the study sponsor or research team.
Daniel Santa Mina, PhD
CONTACT
Ian Randall, MD
CONTACT
University Health Network, Toronto
Other
Evaluating the Effect of a Sleep Prehabilitation Intervention: A Single-blind Randomized Trial
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