Improving Patient Sleep Prior to Elective Surgery

NCT06762639 | Recruiting

• 1 other identifier: 24-5450
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery

Keywords

Sleep; Randomized trial; Prehabilitation; Surgical recovery

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (21)

• 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

Study Arms (2)

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.

Behavioral: Standard of Care Prehabilitation

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: * Brief behavioural treatment for insomnia * Sleep hygiene * Behaviour change support (e.g., goal-setting, use of a wearable tracker to modify behaviour)

Behavioral: Personalized Sleep Prehabilitation (PSP)

Interventions

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: * Brief behavioural treatment for insomnia * Sleep hygiene * Behaviour change support (e.g., goal-setting, use of a wearable tracker to modify behaviour)

Personalized Sleep Prehabilitation

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.

Standard of Care Prehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

Related Publications (1)

• 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. 2025 Aug 30:e70173. doi: 10.1111/jsr.70173. Online ahead of print.

  PMID: 40884156 DERIVED

Related Links

• Prehabilitation Program

Study Officials

• Daniel Santa Mina, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Ian Randall, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Santa Mina, PhD

CONTACT

416-978-1696; daniel.santamina@uhn.ca

Ian Randall, MD

CONTACT

(416) 340-5164; ian.randall@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: January 7, 2025
• Study Start: January 3, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Study protocol may be shared with publication. All other data available on reasonable request.
• Access Criteria: Stakeholders may access the data upon reasonable request. Mechanism and agreement of access will be determined at the time of the request.

Locations

CA (1)