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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if improving sleep habits can enhance sleep quality and aid recovery for patients preparing for elective surgery. Participants will be divided into two groups: one will receive Personalized Sleep Prehabilitation (PSP), which includes personalized sleep support alongside standard pre-surgery care, while the other will receive standard care alone. Ideal candidates typically sleep less than 7 hours a night and experience issues such as trouble falling asleep, frequent awakenings, or daytime sleepiness. Participants will learn techniques to improve their sleep and track their progress using tools like a sleep diary and wearable tracker. As an unphased trial, this study offers participants the opportunity to improve their sleep and recovery before surgery with personalized support.

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 prior data suggests that this sleep prehabilitation protocol is safe for patients undergoing surgery?

Research has shown that improving sleep habits before surgery, known as sleep prehabilitation, is generally safe for participants. Studies indicate that personalized sleep prehabilitation involves activities like practicing good sleep habits and receiving support to change behaviors, such as setting sleep goals and using wearable sleep trackers. These methods are non-invasive and have not been linked to any major negative effects.

Moreover, combining sleep improvement with other health strategies, known as multimodal prehabilitation, has reduced complications after surgery and aided recovery. Since the personalized sleep prehabilitation in this trial adds to standard methods, it is expected to be well-tolerated and safe.

Overall, the trial's approach is designed to help participants, making it a safe option for those considering joining. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Personalized Sleep Prehabilitation (PSP) because it tackles surgical recovery in a new way by adding sleep support to the usual prehabilitation routine. Traditional prehabilitation focuses on exercise, nutrition, and psychosocial support, but PSP goes further by addressing sleep issues with techniques like behavioral treatment for insomnia and sleep hygiene education. This approach could enhance overall health optimization before surgery, potentially improving recovery outcomes by ensuring patients get quality rest.

What evidence suggests that changing sleep behavior could improve recovery from surgery?

Studies have shown that poor sleep can harm wound healing and thinking skills, leading to worse results after surgery. Research suggests that improving sleep before surgery can aid recovery. In this trial, participants may receive Personalized Sleep Prehabilitation (PSP), which includes methods like short treatments for insomnia and tips for better sleep habits. These approaches have effectively improved sleep before surgery. Early findings suggest that better sleep can enhance both sleep quality and overall recovery from surgery. ^{1 2 3 6 7}

Who Is on the Research Team?

Ian Randall, MD

Principal Investigator

University Health Network, Toronto

Daniel Santa Mina, PhD

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jsr.70173?af=R

Evaluating the Effect of a Sleep Prehabilitation Intervention ... Disrupted sleep can impede wound healing and cognitive performance and contribute to poor surgical outcomes. Preoperative intervention aimed at ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06762639

Improving Patient Sleep Prior to Elective Surgery The goal of this clinical trial is to learn if changing sleep behaviour can improve sleep health in patients undergoing prehabilitation before elective ...

3. withpower.com withpower.com/trial/sleep-prehabilitation-for-surgery-eeb30

Sleep Prehabilitation for Surgery Trial Overview The study tests whether Personalized Sleep Prehabilitation (PSP) can enhance sleep before surgery and aid recovery afterwards compared to the ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8424868/

Impact of prehabilitation on objectively measured physical ... Data from single-arm studies tended to suggest that prehabilitation was effective for increasing PA levels across the intervention period (three out of four).

5. sciencedirect.com sciencedirect.com/science/article/pii/S2161831325000286

Prehabilitation Strategies: Enhancing Surgical Resilience ... Relaxation techniques, such as guided imagery and mindfulness training, have proven effective in reducing anxiety levels and improving focus on prehabilitation ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8059351/

Prehabilitation, making patients fit for surgery – a new ... High-level evidence that multimodal prehabilitation will reduce complications and improve outcome must come from randomized studies. The research group of Dr. G ...

7. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0303829

Multimodal prehabilitation (Fit4Surgery) in high-impact ... Multimodal prehabilitation has demonstrated a reduction in postoperative complications and enhanced functional recovery, mainly in abdominal cancer surgery.