TRANslating Sleep Health Into QUaLity of Recovery (TRANQUiL) Study (TRANQUiL)

April 24, 2023 updated by: Women's College Hospital

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 is a novel observational study with the overarching aim of evaluating the association between poor sleep health and poor quality of recovery in a surgical setting. It hopes to assess and optimize the perioperative sleep health of patients so significant improvements in their quality of recovery and health outcomes may be achieved.

Study Overview

Status

Recruiting

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:

  1. 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.
  2. 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.
  3. To validate a set of subjective and objective measures of various sleep health domains in the post-operative period.

Study Type

Observational

Enrollment (Anticipated)

260

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M5S 1B2
        • Recruiting
        • Women's College Hospital
        • Principal Investigator:
          • Mandeep Singh, MD
        • Sub-Investigator:
          • Richard Brull, MD
        • Contact:
        • Contact:
      • Toronto, Ontario, Canada, M5T 2S8
        • Recruiting
        • Toronto Western Hospital (University Health Network)
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

260 patients will be recruited from the preoperative clinics at major academic centers: Women's College Hospital (WCH) - Coordinating center, Toronto Western Hospital (TWH) - University Health Network (UHN); and St. Michaels Hospital (SMH), Toronto, Ontario.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mandeep Singh, MD, MSc, Women's College Hospital and Toronto Western Hospital, University Health Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2021

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

July 1, 2024

Study Registration Dates

First Submitted

October 24, 2019

First Submitted That Met QC Criteria

May 20, 2020

First Posted (Actual)

May 21, 2020

Study Record Updates

Last Update Posted (Actual)

April 26, 2023

Last Update Submitted That Met QC Criteria

April 24, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2019-0044-B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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