SurgeryNCT06762639
Improving Patient Sleep Prior to Elective Surgery
A study testing Personalized Sleep Prehabilitation (PSP) in people with Surgery, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- Personalized Sleep Prehabilitation (PSP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteCanada
- Study dates
- 3 Jan 2025to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University Health Network
Toronto, Ontario, M5G 2C4
Research Manager, RN, 416-340-4800 ext. 2927, jo.carroll@uhn.ca
Clinical Coordinator, MSc, 416-340-4800 ext. 416 340 4645, darren.au@uhn.ca
About this study
Official title: Evaluating the Effect of a Sleep Prehabilitation Intervention: A Single-blind Randomized 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:
Read more
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.
Read the detailed description
Sample Size: N = 154
Study Population: Patients participating in UHN's Prehabilitation Program. Participants will be excluded if they are participating in prehabilitation entirely remotely (i.e., no in-person visits), have an existing sleep disorder, are a shift worker, have travel plans outside of usual time zone, or have a cognitive disability that limits answering questionnaires or adhering to the intervention.
Study Design: Randomized trial with outcome assessors blinded to group allocation.
Primary Objective: Measure the effect of a personalized sleep prehabilitation (PSP) in addition to standard of care prehabilitation on participant sleep health compared to standard of care prehabilitation alone.
Secondary Objective: To measure the effect of the PSP versus standard of care prehabilitation on other outcomes including clinical outcomes, patient-reported outcomes, and physical fitness.
Endpoints of the study: Self-reported sleep health via the Pittsburgh Sleep Quality Index (PSQI; primary outcome). Other sleep health outcomes include the insomnia severity scale (ISI), STOP-BANG questionnaire, Restless Leg Syndrome Diagnostic Index, sleep diary, Global Sleep Assessment Questionnaire (GSAQ), and sleep self-efficacy scale. Clinical outcomes include hospital length of stay and surgical complications. Anthropometric and physical fitness outcomes include: body mass index, bioelectrical impedance analysis (lean mass and fat mass), waist circumference, muscular fitness, aerobic fitness, and functional capacity. Device measured outcomes include sleep, physical activity, resting heart rate, and heart rate variability via a wrist-worn activity tracker.
Analysis: Descriptive statistics will be used to characterize participant characteristics. The primary analysis will be an ANCOVA to detect significant differences in PSQI between groups at the preoperative timepoint while controlling for baseline scores. The secondary analysis will be a linear mixed effect model to derive point estimates for effectiveness markers (primary and secondary) at each timepoint, comparing between- and within- group differences at each timepoint. Means and 95% CI will be reported.
Impact: The proposed study will be the first to explore the effect of a PSP in addition to standard-of-care prehabilitation service on sleep health.
- Conditions
- Surgery
- Being tested
- Personalized Sleep Prehabilitation (PSP), Standard of Care Prehabilitation
- Keywords
- Sleep, Randomized trial, Prehabilitation, Surgical recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Sleep Prehabilitation (PSP)Behavioural
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 PrehabilitationBehavioural
Exercise, nutritional support, psychosocial support, education, smoking cessation support, and/or medical care delivered by regulated health professionals included Kinesiologists, Dietitians, Clinical Psychologists, etc.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Prehabilitation | Active comparator | 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. Receives: Behavioral: Standard of Care Prehabilitation |
| Personalized Sleep Prehabilitation | Experimental | 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) Receives: Behavioral: Personalized Sleep Prehabilitation (PSP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a self-report measure of sleep quality among seven subscales including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleep medication, and daytime dysfunction. The scale's validity and reliability has been determined among clinical and older adult populations.
For reporting, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (min: 0 and max: 21). Higher scores indicate worse sleep quality.
Time to completion is 5-10 minutes.
Measured: Administered baseline, one week before surgery, and 45 days after surgery
Secondary outcomes (21)
Sleep self-efficacy scale
Self reported questionnaire measuring confidence in one's ability to change sleep behaviour.
This scale contains 13 items scored 1-5 (min: 13, max: 65). Greater scores indicate more sleep self-efficacy.
Measured: Baseline, 1 week presurgery, 45 days after surgery.
Sleep diary - Sleep duration
Self-reported by the participant in the sleep diary each day for 1 week.
Measured: Baseline, presurgery, 45 days after surgery
Sleep diary - Sleep efficiency
Time in bed and sleep duration are self-reported by the participant in the sleep diary each day for 1 week. Sleep efficiency is calculated as sleep duration/time in bed and expressed as a percentage.
Measured: Baseline, presurgery, 45 days after surgery
Sleep diary - Sleep latency
Self-reported by the participant in the sleep diary each day for 1 week.
Measured: Baseline, presurgery, 45 days after surgery
Sleep diary - Sleep quality
Self-reported by the participant in the sleep diary each day for 1 week using a 5-pt Likert scale ranging from "Very poor" to "Very good" (scored 0-4). Higher scores indicate better quality sleep.
Measured: Baseline, presurgery, 45 days after surgery
Wrist-worn actigraphy - Sleep duration
All participants will be provided with a Fitbit Inspire 3, a small non-intrusive and waterproof device that uses actigraphy to measure orientation and movement and uses photoplethysmography (PPG) to detect periodic changes in blood flow beneath the sensor; thereby measuring changes in heart rate. This device is worn like a wrist-watch. The activity tracker measures sleep-wake activity to measure sleep duration expressed in minutes.
Measured: Baseline, presurgery, 45 days after surgery
Wrist-worn actigraphy - Sleep latency
All participants will be provided with a Fitbit Inspire 3, a small non-intrusive and waterproof device that uses actigraphy to measure orientation and movement and uses photoplethysmography (PPG) to detect periodic changes in blood flow beneath the sensor; thereby measuring changes in heart rate. This device is worn like a wrist-watch. The activity tracker measures sleep-wake activity to measure sleep latency expressed in minutes.
Measured: Baseline, presurgery, 45 days after surgery
Wrist-worn actigraphy - Sleep efficiency
All participants will be provided with a Fitbit Inspire 3, a small non-intrusive and waterproof device that uses actigraphy to measure orientation and movement and uses photoplethysmography (PPG) to detect periodic changes in blood flow beneath the sensor; thereby measuring changes in heart rate. This device is worn like a wrist-watch. The activity tracker measures sleep-wake activity to measure time in bed and time spent sleeping to compute sleep efficiency expressed as a percentage.
Measured: Baseline, presurgery, 45 days after surgery
Wrist-worn actigraphy - Resting heart rate
All participants will be provided with a Fitbit Inspire 3, a small non-intrusive and waterproof device that uses actigraphy to measure orientation and movement and uses photoplethysmography (PPG) to detect periodic changes in blood flow beneath the sensor; thereby measuring changes in heart rate. This device is worn like a wrist-watch. The heart rate monitor will measure resting heart rate (bpm) a metric of overall fitness and autonomic nervous system function. Participants will be provided with setup instructions at their baseline appointment and receive ongoing support for the use of their tracker.
Measured: Baseline, presurgery, 45 days after surgery
Wrist-worn actigraphy - Heart rate variability
All participants will be provided with a Fitbit Inspire 3, a small non-intrusive and waterproof device that uses actigraphy to measure orientation and movement and uses photoplethysmography (PPG) to detect periodic changes in blood flow beneath the sensor; thereby measuring changes in heart rate. This device is worn like a wrist-watch. The heart rate monitor will measure heart rate variability, a metric of overall fitness and autonomic nervous system function. Participants will be provided with setup instructions at their baseline appointment and receive ongoing support for the use of their tracker.
Measured: Baseline, presurgery, 45 days after surgery
Wrist-worn actigraphy - Light intensity physical activity
All participants will be provided with a Fitbit Inspire 3, a small non-intrusive and waterproof device that uses actigraphy to measure orientation and movement and uses photoplethysmography (PPG) to detect periodic changes in blood flow beneath the sensor; thereby measuring changes in heart rate. This device is worn like a wrist-watch. The actigraphy will measure light intensity physical activity reported in minutes.
Measured: Baseline, presurgery, 45 days after surgery
Wrist-worn actigraphy - Moderate-vigorous physical activity
All participants will be provided with a Fitbit Inspire 3, a small non-intrusive and waterproof device that uses actigraphy to measure orientation and movement and uses photoplethysmography (PPG) to detect periodic changes in blood flow beneath the sensor; thereby measuring changes in heart rate. This device is worn like a wrist-watch. The actigraphy will measure moderate-vigorous intensity physical activity reported in minutes.
Measured: Baseline, presurgery, 45 days after surgery
Physical Fitness - Body mass index
A kinesiologist will measure height and weight to calculate body mass index expressed in in kg/m^2
Measured: Baseline, presurgery, 45 days after surgery
Physical Fitness - Body fat %
A kinesiologist will measure body fat percentage with a mBCA 514 (Seca, Hamburg, Germany)
Measured: Baseline, presurgery, 45 days after surgery
Physical Fitness - Grip strength
A kinesiologist will measure grip strength using a handgrip dynamometer
Measured: Baseline, presurgery, 45 days after surgery
Physical Fitness - Six minute walk test
A kinesiologist will measure aerobic fitness using a six-minute walk test on a 60m track.
Measured: Baseline, presurgery, 45 days after surgery
Surgical complications
Surgical complications will be extracted from participant medical records.
Measured: Up to 45 days after surgery
Hospital length of stay
Hospital length of stay will be extracted from participant medical records.
Measured: Up to 45 days after surgery
Discharge destination
Discharge destination will be extracted from participant medical records.
Measured: Up to 45 days after surgery
Readmission to the hospital
Readmissions will be extracted from participant medical records
Measured: Up to 45 days after surgery
PROMIS 29+2
The Patient-Reported Outcomes Measurement Information System (PROMIS) is a set of person-centred measures that evaluates physical, mental, and social health. The PROMIS 29+2 Profile v2.1 (PROPr) will be administered. The PROMIS instruments have been used and validated extensively in clinical
There are 31 questions answered using a Likert scale from 1-5. Each domain (physical function, anxiety, depression, cognitive function, sleep disturbance, fatigue, social activity, and pain) has 2-4 items. Higher score is more of that concept. Raw scores are converted into T scores. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10.
Time to completion: 5-10 minutes
Measured: Baseline, presurgery, 45 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start3 Jan 2025
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Santa Mina, PhD, Principal investigator, University Health Network, TorontoIan Randall, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06762639
- Sponsor's protocol ID
- 24-5450
- Status last verified
- Mar 2025
- First submitted
- 19 Dec 2024
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD that underlie results in a publication
Publications
Sibley D, Randall I, Culos-Reed SN, Slepian PM, Singh M, Mina DS. Evaluating the Effect of a Sleep Prehabilitation Intervention in Patients Awaiting Elective Surgery: Protocol for a Single-Blind Randomised Trial. J Sleep Res. 2026 Apr;35(2):e70173. doi: 10.1111/jsr.70173. Epub 2025 Aug 30.
PubMed 40884156
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of a Sleep Prehabilitation Intervention: A Single-blind Randomized Trial
- ClinicalTrials.gov ID
- NCT06762639
- Acronym / sponsor ID
- 24-5450
- Conditions
- Surgery
- Keywords
- Sleep, Randomized trial, Prehabilitation, Surgical recovery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 3 Jan 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Sample Size: N = 154
Study Population: Patients participating in UHN's Prehabilitation Program. Participants will be excluded if they are participating in prehabilitation entirely remotely (i.e., no in-person visits), have an existing sleep disorder, are a shift worker, have travel plans outside of usual time zone, or have a cognitive disability that limits answering questionnaires or adhering to the intervention.
Study Design: Randomized trial with outcome assessors blinded to group allocation.
Primary Objective: Measure the effect of a personalized sleep prehabilitation (PSP) in addition to standard of care prehabilitation on participant sleep health compared to standard of care prehabilitation alone.
Secondary Objective: To measure the effect of the PSP versus standard of care prehabilitation on other outcomes including clinical outcomes, patient-reported outcomes, and physical fitness.
Endpoints of the study: Self-reported sleep health via the Pittsburgh Sleep Quality Index (PSQI; primary outcome). Other sleep health outcomes include the insomnia severity scale (ISI), STOP-BANG questionnaire, Restless Leg Syndrome Diagnostic Index, sleep diary, Global Sleep Assessment Questionnaire (GSAQ), and sleep self-efficacy scale. Clinical outcomes include hospital length of stay and surgical complications. Anthropometric and physical fitness outcomes include: body mass index, bioelectrical impedance analysis (lean mass and fat mass), waist circumference, muscular fitness, aerobic fitness, and functional capacity. Device measured outcomes include sleep, physical activity, resting heart rate, and heart rate variability via a wrist-worn activity tracker.
Analysis: Descriptive statistics will be used to characterize participant characteristics. The primary analysis will be an ANCOVA to detect significant differences in PSQI between groups at the preoperative timepoint while controlling for baseline scores. The secondary analysis will be a linear mixed effect model to derive point estimates for effectiveness markers (primary and secondary) at each timepoint, comparing between- and within- group differences at each timepoint. Means and 95% CI will be reported.
Impact: The proposed study will be the first to explore the effect of a PSP in addition to standard-of-care prehabilitation service on sleep health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Prehabilitation | Active comparator | Behavioral: Standard of Care PrehabilitationPrehabilitation 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. |
| Personalized Sleep Prehabilitation | Experimental | Behavioral: 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Behavioural | Personalized Sleep Prehabilitation |
| Standard of Care PrehabilitationExercise, nutritional support, psychosocial support, education, smoking cessation support, and/or medical care delivered by regulated health professionals included Kinesiologists, Dietitians, Clinical Psychologists, etc. | Behavioural | Standard of Care Prehabilitation |
Primary outcome
The Pittsburgh Sleep Quality Index (PSQI)
Time frame: Administered baseline, one week before surgery, and 45 days after surgery
The PSQI is a self-report measure of sleep quality among seven subscales including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleep medication, and daytime dysfunction. The scale's validity and reliability has been determined among clinical and older adult populations. For reporting, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (min: 0 and max: 21). Higher scores indicate worse sleep quality. Time to completion is 5-10 minutes.
21 secondary outcomes
Sleep self-efficacy scale
Time frame: Baseline, 1 week presurgery, 45 days after surgery.
Sleep diary - Sleep duration
Time frame: Baseline, presurgery, 45 days after surgery
Sleep diary - Sleep efficiency
Time frame: Baseline, presurgery, 45 days after surgery
Sleep diary - Sleep latency
Time frame: Baseline, presurgery, 45 days after surgery
Sleep diary - Sleep quality
Time frame: Baseline, presurgery, 45 days after surgery
Wrist-worn actigraphy - Sleep duration
Time frame: Baseline, presurgery, 45 days after surgery
Wrist-worn actigraphy - Sleep latency
Time frame: Baseline, presurgery, 45 days after surgery
Wrist-worn actigraphy - Sleep efficiency
Time frame: Baseline, presurgery, 45 days after surgery
Wrist-worn actigraphy - Resting heart rate
Time frame: Baseline, presurgery, 45 days after surgery
Wrist-worn actigraphy - Heart rate variability
Time frame: Baseline, presurgery, 45 days after surgery
Wrist-worn actigraphy - Light intensity physical activity
Time frame: Baseline, presurgery, 45 days after surgery
Wrist-worn actigraphy - Moderate-vigorous physical activity
Time frame: Baseline, presurgery, 45 days after surgery
Physical Fitness - Body mass index
Time frame: Baseline, presurgery, 45 days after surgery
Physical Fitness - Body fat %
Time frame: Baseline, presurgery, 45 days after surgery
Physical Fitness - Grip strength
Time frame: Baseline, presurgery, 45 days after surgery
Physical Fitness - Six minute walk test
Time frame: Baseline, presurgery, 45 days after surgery
Surgical complications
Time frame: Up to 45 days after surgery
Hospital length of stay
Time frame: Up to 45 days after surgery
Discharge destination
Time frame: Up to 45 days after surgery
Readmission to the hospital
Time frame: Up to 45 days after surgery
PROMIS 29+2
Time frame: Baseline, presurgery, 45 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Derived from this study: PubMed 40884156Sibley D, Randall I, Culos-Reed SN, Slepian PM, Singh M, Mina DS. Evaluating the Effect of a Sleep Prehabilitation Intervention in Patients Awaiting Elective Surgery: Protocol for a Single-Blind Randomised Trial. J Sleep Res. 2026 Apr;35(2):e70173. doi: 10.1111/jsr.70173. Epub 2025 Aug 30.
- Prehabilitation ProgramLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Santa Mina, PhD principal investigator
University Health Network, Toronto
Ian Randall, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Sleep Prehabilitation (PSP) in people with Surgery, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Santa Mina, PhD (416-978-1696, daniel.santamina@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Pittsburgh Sleep Quality Index (PSQI) (time frame: Administered baseline, one week before surgery, and 45 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06762639, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.