Sleep Prehabilitation for Surgery

Overseen By Daniel Santa Mina, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Sleep disorder, Shift worker, Travel plans, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

154 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on improving sleep behavior before surgery.

What data supports the effectiveness of the treatment Personalized Sleep Prehabilitation (PSP) for surgery?

Research shows that sleep disturbances are common before surgery and can negatively impact recovery. Addressing these sleep issues with treatments like Personalized Sleep Prehabilitation may help improve postoperative outcomes by reducing complications related to poor sleep. ^{1 2 3 4 5}

How is the Personalized Sleep Prehabilitation (PSP) treatment different from other treatments for sleep issues before surgery?

The Personalized Sleep Prehabilitation (PSP) treatment is unique because it focuses on preparing patients for surgery by enhancing their sleep quality through a tailored approach, which may include exercise, nutrition, and psychological support. This is different from standard treatments that typically address sleep issues after surgery rather than before. ^{6 7 8 9 10}

What is the purpose of this trial?

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.

Research Team

Daniel Santa Mina, PhD

Principal Investigator

University Health Network, Toronto

Ian Randall, MD

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

This trial is for patients preparing for elective surgery who want to improve their sleep health. Participants should be interested in prehabilitation, which includes exercise, nutrition, and psychological support. They must commit to attending four meetings with researchers and tracking their sleep using questionnaires, a diary, and a wearable device.

Inclusion Criteria

My surgery is scheduled between 4 to 12 weeks from now.

I often feel sleepy during the day.

Currently sleep less than 7 hours on most nights in the past month

Exclusion Criteria

I am not proficient in English.

I do not have a cognitive disability that affects my ability to answer questions or follow treatment plans.

Currently a shift worker (work schedule outside of 7am-6pm)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants receive prehabilitation including exercise, nutritional support, and sleep support

4 weeks

4 meetings with the research team

Follow-up

Participants are monitored for sleep health and recovery after surgery

6 weeks

Treatment Details

Interventions

• Personalized Sleep Prehabilitation (PSP)
• Standard of Care Prehabilitation

Trial Overview The study tests whether Personalized Sleep Prehabilitation (PSP) can enhance sleep before surgery and aid recovery afterwards compared to the Standard of Care Prehabilitation. It involves learning about better sleep habits and possibly using tools or techniques designed to improve sleep quality.

Participant Groups

Group I: Personalized Sleep Prehabilitation Experimental Treatment 1 Intervention

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)

Group II: Standard of Care Prehabilitation Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Findings from Research

In a study of 112 patients scheduled for colorectal surgery, a simpler regimen of walking and breathing exercises led to a greater improvement in functional walking capacity compared to a structured regimen of stationary cycling and strengthening exercises.

At the end of the prehabilitation period, 47% of patients in the walking group showed improvement in walking capacity, compared to only 22% in the cycling group, highlighting the unexpected effectiveness of the simpler approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized clinical trial of prehabilitation in colorectal surgery. Carli, F., Charlebois, P., Stein, B., et al.[2022]

References

1. Japan pubmed.ncbi.nlm.nih.gov

Preoperative sleep disruption and postoperative functional disability in lung surgery patients: a prospective observational study. [2020]

2. England pubmed.ncbi.nlm.nih.gov

The prevalence and risk factors of sleep disturbances in surgical patients: A systematic review and meta-analysis. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Sleep Loss the night before surgery and incidence of postoperative delirium in adults 65-95 years of age. [2023]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Development and Validation of Nomogram Prediction Model for Postoperative Sleep Disturbance in Patients Undergoing Non-Cardiac Surgery: A Prospective Cohort Study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Exploration of Perioperative Sleep Disturbance in 208 Patients Undergoing Non-Cardiac Surgery: Protocol for a Prospective Cohort Study. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Exercise intervention in cancer patients with sleep disturbances scheduled for elective surgery: Systematic review. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Contemporary Opportunity for Prehabilitation as Part of an Enhanced Recovery after Surgery Pathway in Colorectal Surgery. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Tailoring prehabilitation to address the multifactorial nature of functional capacity for surgery. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Randomized clinical trial of prehabilitation in colorectal surgery. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Multi-modal prehabilitation: addressing the why, when, what, how, who and where next? [2019]