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Sleep DisorderTRANQUiLNCT04398082

TRANslating Sleep Health Into QUaLity of Recovery (TRANQUiL) Study

An observational study of Sleep Disorder and Sleep Disturbance, run by Women's College Hospital at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sleep Disorder, Sleep Disturbance
How many people
174 participants
Where
2 sitesCanada
Study dates
10 Mar 2021to 1 Jan 2026
Phase
Observational
Are there results?
None posted in the registry

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

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.

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • Women's College Hospital

    Toronto, Ontario, M5S 1B2

  • Toronto Western Hospital (University Health Network)

    Toronto, Ontario, M5T 2S8

Other trials in Canada

About this study

Official title: 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.

Read the 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.
Keywords
sleep
Medical subject headings
Sleep Wake Disorders, Parasomnias

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 48 hours postoperatively

  2. 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).

    Measured: 48 hours postoperatively

Secondary outcomes (9)

  1. Pittsburgh Sleep Quality Index (PSQI) Scores

    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.

    Measured: 3 months postoperatively

  2. Consensus Sleep Diary (CSD) Scores

    The Consensus Sleep Diary (CSD) is a standardized, prospective tool for tracking nightly subjective sleep.

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

  3. Functional Outcomes in Sleep Questionnaire (FOSQ)

    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.

    Measured: 7 days prior surgery and 3 months postoperatively

  4. Hospital Anxiety and Depression Scale (HADS)

    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.

    Measured: Baseline and 3 months postoperatively

  5. Fluid Intake and Output

    Postoperative assessment of the fluid intake and output.

    Measured: 48 hours

  6. Visual analogue pain scores (VAS)

    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."

    Measured: 48 hours

  7. Postoperative complications

    Assessment of the severity of the postoperative complications

    Measured: 48 hours and 30 days

  8. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score

    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.

    Measured: Baseline and 3 months postoperatively

  9. Epworth Sleepiness Scale (ESS)

    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.

    Measured: Baseline and 3 months postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2020
  2. Study start10 Mar 2021
  3. Primary completion31 Aug 2024
  4. Study completion1 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
174 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04398082
Sponsor's protocol ID
2019-0044-B
Acronym
TRANQUiL
Status last verified
Apr 2026
First submitted
24 Oct 2019
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Sleep Disorder and Sleep Disturbance, run by Women's College Hospital at 2 sites 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of recovery-15 score at 48 hrs postoperatively (time frame: 48 hours postoperatively). The study lists 2 primary outcomes in all. 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 NCT04398082.

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 23 Apr 2026.

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