Clinical trial NCT06762639: Improving Patient Sleep Prior to Elective Surgery
Official title: Evaluating the Effect of a Sleep Prehabilitation Intervention: A Single-blind Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Surgery
Keywords: Sleep
Randomized trial
Prehabilitation
Surgical recovery
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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)

Primary outcomes:
measure: The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Administered baseline, one week before surgery, and 45 days after surgery
Secondary outcomes:
measure: Sleep self-efficacy scale
timeFrame: Baseline, 1 week presurgery, 45 days after surgery.
measure: Sleep diary - Sleep duration
timeFrame: Baseline, presurgery, 45 days after surgery
measure: Sleep diary - Sleep efficiency
timeFrame: Baseline, presurgery, 45 days after surgery
measure: Sleep diary - Sleep latency
timeFrame: Baseline, presurgery, 45 days after surgery
measure: Sleep diary - Sleep quality
timeFrame: Baseline, presurgery, 45 days after surgery
measure: Wrist-worn actigraphy - Sleep duration
timeFrame: Baseline, presurgery, 45 days after surgery
measure: Wrist-worn actigraphy - Sleep latency
timeFrame: Baseline, presurgery, 45 days after surgery
measure: Wrist-worn actigraphy - Sleep efficiency
timeFrame: Baseline, presurgery, 45 days after surgery
measure: Wrist-worn actigraphy - Resting heart rate
timeFrame: Baseline, presurgery, 45 days after surgery
measure: Wrist-worn actigraphy - Heart rate variability
timeFrame: Baseline, presurgery, 45 days after surgery
measure: Wrist-worn actigraphy - Light intensity physical activity
timeFrame: Baseline, presurgery, 45 days after surgery
measure: Wrist-worn actigraphy - Moderate-vigorous physical activity
timeFrame: Baseline, presurgery, 45 days after surgery
measure: Physical Fitness - Body mass index
timeFrame: Baseline, presurgery, 45 days after surgery
measure: Physical Fitness - Body fat %
timeFrame: Baseline, presurgery, 45 days after surgery
measure: Physical Fitness - Grip strength
timeFrame: Baseline, presurgery, 45 days after surgery
measure: Physical Fitness - Six minute walk test
timeFrame: Baseline, presurgery, 45 days after surgery
measure: Surgical complications
timeFrame: Up to 45 days after surgery
measure: Hospital length of stay
timeFrame: Up to 45 days after surgery
measure: Discharge destination
timeFrame: Up to 45 days after surgery
measure: Readmission to the hospital
timeFrame: Up to 45 days after surgery
measure: PROMIS 29+2
timeFrame: Baseline, presurgery, 45 days after surgery
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Daniel Santa Mina, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network, Toronto
name: Ian Randall, MD
role: PRINCIPAL_INVESTIGATOR
References: