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Personalized Sleep Prehabilitation Impact on Sleep Health and Clinical Outcomes

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Study Aim

This study aims to prevent sleep issues by evaluating the impact of personalized sleep prehabilitation on your sleep health, using the Pittsburgh Sleep Quality Index (PSQI) as a measure of sleep quality, duration, efficiency, and daytime dysfunction.

What is being tested

Personalized Sleep Prehabilitation (PSP)

+ Standard of Care Prehabilitation

Behavioral
Who is being recruted

Over 18 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: January 2025
See protocol details

Summary

Principal SponsorUniversity Health Network, Toronto
Study ContactDaniel Santa Mina, PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 3, 2025

Actual date on which the first participant was enrolled.

The study aims to understand how a personalized sleep program can improve sleep health for patients involved in prehabilitation programs before surgery. The focus is on those who attend in-person sessions and do not have pre-existing sleep disorders or other factors that might affect sleep patterns, like shift work or travel across time zones. Improving sleep health in this group is crucial as it may lead to better recovery outcomes, reduced hospital stays, and overall enhanced physical fitness. Participants will engage in a personalized sleep intervention along with their standard prehabilitation care. The study evaluates sleep improvements using self-reported measures like the Pittsburgh Sleep Quality Index and other sleep-related questionnaires. Clinical outcomes such as hospital stay duration and surgical complications will also be monitored. Physical health is assessed through measurements like body mass index and fitness tests, while a wrist-worn tracker records sleep and activity data. The study's results could provide valuable insights into the benefits of tailored sleep programs in surgical recovery.

Official TitleEvaluating the Effect of a Sleep Prehabilitation Intervention: A Single-blind Randomized Trial
NCT06762639
Principal SponsorUniversity Health Network, Toronto
Study ContactDaniel Santa Mina, PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

154 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

6 inclusion criteria required to participate
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
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5 exclusion criteria prevent from participating
have an existing diagnosed sleep disorder that is poorly managed or requires referral to a sleep clinician
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)
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants in this group receive usual care such as exercise, nutrition support, and medical care, with added sleep support. This includes brief insomnia treatment, sleep hygiene tips, and behavior change support using wearable trackers and goal-setting.

Group II

Active Comparator
Participants receive personalized health improvement interventions, including exercise, nutrition support, psychological assistance, education, smoking cessation aid, and medical care from professionals like Kinesiologists, Dietitians, Clinical Psychologists, etc.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

University Health Network

Toronto, CanadaOpen University Health Network in Google Maps
Recruiting
One Study Center