Recruiting

Observational Study

Sponsor:

University Health Network, Toronto

Code:

NCT06762639

Conditions

Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Personalized Sleep Prehabilitation (PSP)

Standard of Care Prehabilitation

Study Details

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

Study ID

NCT06762639

Start date

Jan 3, 2025

Status verified date

Mar, 2025

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

154 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Standard of Care Prehabilitation

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.

experimental: Personalized Sleep Prehabilitation

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)

Interventions

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)

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 measure

  • The Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Administered baseline, one week before surgery, and 45 days after surgery ]

Central Contacts and Locations

Central contacts

Daniel Santa Mina, PhD

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

Ian Randall, MD

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

Locations

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Research Manager, RN

416-340-4800jo.carroll@uhn.ca

Clinical Coordinator, MSc

416-340-4800darren.au@uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Mar 25, 2025

Last verified

Mar, 2025

Keywords

  • Sleep
  • Randomized trial
  • Prehabilitation
  • Surgical recovery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2025-03-25.