Evaluating the impact of sleep health on recovery after surgery
TRANslating Sleep Health Into QUaLity of Recovery (TRANQUiL) Study: A Multi-center Prospective Cohort Study of Sleep Health and Activity Measures Predicting Meaningful and Patient-centric Outcomes Following Non-cardiac Surgeries.
This study is testing how poor sleep affects recovery for people having joint replacement surgeries to see if better sleep can lead to less pain and fewer complications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 260 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Women's College Hospital Academic / other |
| Locations | 2 sites (Toronto, Ontario and 1 other locations) |
| Trial ID | NCT04398082 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the relationship between poor sleep health and the quality of recovery in patients undergoing elective lower limb joint replacement surgeries. It will evaluate pre-operative sleep health parameters and their association with patient-centered outcomes such as pain control and delirium. The study will utilize various sleep health measurements to understand how sleep disturbances affect recovery and overall health outcomes in a surgical setting.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients over 18 years old undergoing elective primary or revision lower limb joint replacement surgeries.
Not a fit: Patients undergoing emergency surgeries or those with specific exclusions such as pregnancy or inability to comply with monitoring requirements may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery outcomes for surgical patients by optimizing their sleep health.
How similar studies have performed: Other studies have shown promising results in improving recovery outcomes through better management of sleep health, indicating that this approach has potential.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult patients (\>18 years). 2. ASA physical status I - IV. 3. Undergoing elective primary or revision lower limb joint replacement surgeries (such as total or partial hip or knee replacement). Exclusion Criteria: 1. Patients undergoing emergency surgeries; cardiac, trauma, organ transplantation or organ retrieval, obstetric or intracranial neurosurgeries. 2. Pregnant or lactating patients. 3. Inability to wear study-related monitoring devices per instruction or provide informed consent limiting adherence to protocol.
Where this trial is running
Toronto, Ontario and 1 other locations
- Women's College Hospital — Toronto, Ontario, Canada (Recruiting)
- Toronto Western Hospital (University Health Network) — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Mandeep Singh, MD, MSc — Women's College Hospital and Toronto Western Hospital, University Health Network
- Study coordinator: Laurentia Enesi
- Email: Laurentia.Enesi@wchospital.ca
- Phone: 416-323-6400
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.