Improving Patient Sleep Prior to Elective Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Personalized Sleep Prehabilitation (PSP), Standard of Care Prehabilitation.
- Who it may be relevant to
- Registry conditions: Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluating the Effect of a Sleep Prehabilitation Intervention: A Single-blind Randomized Trial
Overview
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.
Detailed description
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.
Interventions
- Behavioral Personalized Sleep Prehabilitation (PSP)
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: * Brief behavioural treatment for insomnia * Sleep hygiene * Behaviour change support (e.g., goal-setting, use of a wearable tracker to modify behaviour) - Behavioral Standard of Care Prehabilitation
Exercise, nutritional support, psychosocial support, education, smoking cessation support, and/or medical care delivered by regulated health professionals included Kinesiologists, Dietitians, Clinical Psychologists, etc.
Primary outcome measures
- The Pittsburgh Sleep Quality Index (PSQI) [Time frame: Administered baseline, one week before surgery, and 45 days after surgery]
Secondary outcome measures (12)
- Sleep self-efficacy scale [Time frame: Baseline, 1 week presurgery, 45 days after surgery.]
- Sleep diary - Sleep duration [Time frame: Baseline, presurgery, 45 days after surgery]
- Sleep diary - Sleep efficiency [Time frame: Baseline, presurgery, 45 days after surgery]
- Sleep diary - Sleep latency [Time frame: Baseline, presurgery, 45 days after surgery]
- Sleep diary - Sleep quality [Time frame: Baseline, presurgery, 45 days after surgery]
- Wrist-worn actigraphy - Sleep duration [Time frame: Baseline, presurgery, 45 days after surgery]
- Wrist-worn actigraphy - Sleep latency [Time frame: Baseline, presurgery, 45 days after surgery]
- Wrist-worn actigraphy - Sleep efficiency [Time frame: Baseline, presurgery, 45 days after surgery]
- Wrist-worn actigraphy - Resting heart rate [Time frame: Baseline, presurgery, 45 days after surgery]
- Wrist-worn actigraphy - Heart rate variability [Time frame: Baseline, presurgery, 45 days after surgery]
- Wrist-worn actigraphy - Light intensity physical activity [Time frame: Baseline, presurgery, 45 days after surgery]
- Wrist-worn actigraphy - Moderate-vigorous physical activity [Time frame: Baseline, presurgery, 45 days after surgery]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Canada · 1 center
- University Health Network — Toronto
Publications
- 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. PMID 40884156
Identifiers
NCT: NCT06762639 · 24-5450