- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04398082
TRANslating Sleep Health Into QUaLity of Recovery (TRANQUiL) Study (TRANQUiL)
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.
Study Overview
Status
Conditions
Detailed Description
Surgery and pain may cause sleep disturbances that affect both physical and mental well-being of patients. Sleep disturbance can cause an increased risk of confusion after surgery, increased pain needing some or more medication, untoward events (heart and breathing problems), delayed recovery and increased lengths of hospital stay.
Hospitalization interferes with sleep patterns, causing poor quality sleep due to noise, light, pain, medication administration and nursing checks. The circadian rhythm, which is the "body clock" is a 24-hour cycle that tells our bodies when to sleep and rise. This in turn helps in regulating many physiological processes in the body. Sleep disruption affects the body clock, thereby changing hormone levels that may be responsible for poor wound healing. This study aims to evaluate sleep problems before disruption post-operatively and also evaluate the relation between poor sleep health and quality of recovery utilizing sleep health measurements such as sleep quality, sleep timing, and sleep efficiency.
Objectives of the study:
- To examine the associations between specific pre-operative sleep-health parameters, predicting poor sleep health, and patient-centered outcomes such as pain control, delirium, sleep-related quality of life, and quality of recovery scores in the peri-operative period.
- To estimate the association between presence of intrinsic sleep disorders and patient centric outcomes such as pain control, delirium, sleep-related quality of life and quality of recovery scores in the post-operative period.
- To validate a set of subjective and objective measures of various sleep health domains in the post-operative period.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Laurentia Enesi
- Phone Number: 2537 416-323-6400
- Email: Laurentia.Enesi@wchospital.ca
Study Contact Backup
- Name: MaryJane Salpeter
- Email: MaryJane.Salpeter@wchospital.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5S 1B2
- Recruiting
- Women's College Hospital
-
Principal Investigator:
- Mandeep Singh, MD
-
Sub-Investigator:
- Richard Brull, MD
-
Contact:
- Laurentia Enesi, M.B, B.S
- Phone Number: 2537 416-323-6400
- Email: Laurentia.Enesi@wchospital.ca
-
Contact:
- Deborah Mancini
- Phone Number: 416-323-6008
- Email: deborah.mancini@wchospital.ca
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Toronto, Ontario, Canada, M5T 2S8
- Recruiting
- Toronto Western Hospital (University Health Network)
-
Contact:
- Deborah Mancini
- Phone Number: 5269 416-603-5800
- Email: deb.mancini@uhn.ca
-
Contact:
- Laurentia Enesi, M.B, B.S
- Phone Number: 3959 416-603-5800
- Email: Laurentia.Enesi@uhnresearch.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients (>18 years).
- ASA physical status I - IV.
- Undergoing elective primary or revision lower limb joint replacement surgeries (such as total or partial hip or knee replacement).
Exclusion Criteria:
- Patients undergoing emergency surgeries; cardiac, trauma, organ transplantation or organ retrieval, obstetric or intracranial neurosurgeries.
- Pregnant or lactating patients.
- Inability to wear study-related monitoring devices per instruction or provide informed consent limiting adherence to protocol.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of recovery-15 score at 48 hrs postoperatively
Time Frame: 48 hours postoperatively
|
QoR-15 Score is a validated patient-reported outcome questionnaire that measures the quality of recovery after surgery and anesthesia.
Aggregate changes in QoR-15 scores (e.g., mean and SD) will be reported.
|
48 hours postoperatively
|
The diagnostic accuracy of each of the actigraphy derived measures
Time Frame: 48 hours postoperatively
|
The diagnostic accuracy of each of the actigraphy derived measures with reference to the standard test will be calculated using the Receiver Operating Characteristic (ROC) curve, Sensitivity, Specificity, Positive predictive value (PPV), Negative predictive value (NPV), Positive Likelihood ratio, Negative Likelihood ratios, and Diagnostic Odds Ratio (DOR).
|
48 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pittsburgh Sleep Quality Index (PSQI) Scores
Time Frame: 3 months postoperatively
|
The Pittsburgh Sleep Quality Index (PSQI) is a standardized sleep questionnaire for multiple populations.
It has seven component scores and a composite score to assess sleep health and daytime dysfunction in the past month.
|
3 months postoperatively
|
Consensus Sleep Diary (CSD) Scores
Time Frame: 7 days prior surgery, 7 days, and 3 months postoperatively
|
The Consensus Sleep Diary (CSD) is a standardized, prospective tool for tracking nightly subjective sleep.
|
7 days prior surgery, 7 days, and 3 months postoperatively
|
Functional Outcomes in Sleep Questionnaire (FOSQ)
Time Frame: 7 days prior surgery and 3 months postoperatively
|
The short-form FOSQ-10 scale has good psychometric properties with increased usability.
It is a disease-specific instrument designed to assess the sleep-related quality of life measures.
|
7 days prior surgery and 3 months postoperatively
|
Hospital Anxiety and Depression Scale (HADS)
Time Frame: Baseline and 3 months postoperatively
|
The HADS is a very brief, easy to use screening measure comprising of 14 items measuring cognitive and emotional aspects of anxiety and depression.
It has good psychometric properties for medical patients.
|
Baseline and 3 months postoperatively
|
Fluid Intake and Output
Time Frame: 48 hours
|
Postoperative assessment of the fluid intake and output.
|
48 hours
|
Visual analogue pain scores (VAS)
Time Frame: 48 hours
|
The VAS is a simple way for patients to rate the intensity of their pain.
This pain scale shows a 10-centimeter line printed on a piece of paper, with anchors at either end and marked from 0-10.
At one end is "no pain," and at the other end are "pain as bad as it could be" or "the worst imaginable pain."
|
48 hours
|
Postoperative complications
Time Frame: 48 hours and 30 days
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Assessment of the severity of the postoperative complications
|
48 hours and 30 days
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score
Time Frame: Baseline and 3 months postoperatively
|
The WOMAC questionnaire assesses the three dimensions of pain, disability and joint stiffness in knee and hip osteoarthritis using a battery of 24 questions in 5-point Likert, 100mm Visual Analogue and 11-box Numerical Rating Scale formats.
It is a valid, reliable and responsive measure of outcome, and has been used in diverse clinical and interventional environments.
|
Baseline and 3 months postoperatively
|
Epworth Sleepiness Scale (ESS)
Time Frame: Baseline and 3 months postoperatively
|
The ESS is self-administered where the subjects are asked to rate on 0-3 scales how likely they would be to doze off or fall asleep in the eight situations.
A summary score is generated where total score of >10 indicates excessive daytime sleepiness.
|
Baseline and 3 months postoperatively
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mandeep Singh, MD, MSc, Women's College Hospital and Toronto Western Hospital, University Health Network
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-0044-B
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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