Improving sleep health before elective surgery
Evaluating the Effect of a Sleep Prehabilitation Intervention: A Single-blind Randomized Trial
This study is testing if helping people improve their sleep before elective surgery can lead to better sleep quality and recovery compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 154 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06762639 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine if modifying sleep behavior can enhance sleep quality in patients preparing for elective surgery through a prehabilitation program. Participants will be randomly assigned to receive personalized sleep support or standard prehabilitation care, with their sleep health and recovery outcomes compared. The study involves four meetings with the research team, where participants will learn strategies to improve their sleep, and their progress will be monitored using questionnaires and wearable sleep trackers. The primary focus is on assessing the impact of personalized sleep prehabilitation on sleep health and surgical recovery.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for elective surgery who struggle with sleep and are participating in a prehabilitation program.
Not a fit: Patients with existing sleep disorders, shift workers, or those traveling outside their time zone may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved sleep quality and faster recovery for patients undergoing elective surgery.
How similar studies have performed: While the specific approach of personalized sleep prehabilitation is novel, similar studies have shown that improving sleep can positively impact surgical recovery.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Toronto, Ontario
- University Health Network — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Daniel Santa Mina, PhD — University Health Network, Toronto
- Study coordinator: Daniel Santa Mina, PhD
- Email: daniel.santamina@uhn.ca
- Phone: 416-978-1696
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.