TRANslating Sleep Health Into QUaLity of Recovery (TRANQUiL) Study

NCT04398082 | Completed

• 1 other identifier: 2019-0044-B
• Study Type: observational
• Target: 174
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Sleep Disorder; Sleep Disturbance

Keywords

sleep

Outcome Measures

Primary Outcomes (2)

• Quality of recovery-15 score at 48 hrs 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

  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 Outcomes (9)

• Pittsburgh Sleep Quality Index (PSQI) Scores

  3 months postoperatively

• Consensus Sleep Diary (CSD) Scores

  7 days prior surgery, 7 days, and 3 months postoperatively

• Functional Outcomes in Sleep Questionnaire (FOSQ)

  7 days prior surgery and 3 months postoperatively

• Hospital Anxiety and Depression Scale (HADS)

  Baseline and 3 months postoperatively

• Fluid Intake and Output

  48 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Women's College Hospital: lead
• University Health Network, Toronto: collaborator

Study Sites (2)

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

Toronto Western Hospital (University Health Network)

Toronto, Ontario, M5T 2S8, Canada

Location

MeSH Terms

Conditions

Sleep Wake Disorders; Parasomnias

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Mandeep Singh, MD, MSc

  Women's College Hospital and Toronto Western Hospital, University Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: May 21, 2020
• Study Start: March 10, 2021
• Primary Completion: August 31, 2024
• Study Completion: January 1, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

CA (2)