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NCT Number: NCT04398082

TRANslating Sleep Health Into QUaLity of Recovery (TRANQUiL) Study

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.

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Key information

Conditions

Sleep Disorder Mental Disorders Nervous System Diseases Neurologic Manifestations Parasomnias Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disturbance Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Toronto Western Hospital (University Health Network), Toronto, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Fluid Intake and Output

    Time frame: 48 hours

    Postoperative assessment of the fluid intake and output.

  6. 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."

  7. Postoperative complications

    Time frame: 48 hours and 30 days

    Assessment of the severity of the postoperative complications

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

Women's College Hospital

Other

Collaborators

  • University Health Network, Toronto

Registry information

Official study 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.

Acronym: TRANQUiL

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
May 21, 2020
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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