TRANslating Sleep Health Into QUaLity of Recovery (TRANQUiL) Study

Sleep Disturbance Clinical Trial

— TRANQUiL  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04398082
• Other study ID #: 2019-0044-B
• Status: Recruiting
• Start date: March 10, 2021
• Est. completion date: July 2025

Study information

• Verified date: April 2024
• Source: Women's College Hospital
• Contact: Laurentia Enesi
• Phone: 416-323-6400
• Email: Laurentia.Enesi[@]wchospital.ca
• Is FDA regulated: No
• Study type: Observational

Clinical 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 outcomes may be achieved.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: July 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Sleep Disorder
• Sleep Disturbance
• Sleep Wake Disorders

Locations

Country	Name	City	State
Canada	Toronto Western Hospital (University Health Network)	Toronto	Ontario
Canada	Women's College Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Women's College Hospital	University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	3 months postoperatively
Secondary	Consensus Sleep Diary (CSD) Scores	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
Secondary	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.	7 days prior surgery and 3 months postoperatively
Secondary	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.	Baseline and 3 months postoperatively
Secondary	Fluid Intake and Output	Postoperative assessment of the fluid intake and output.	48 hours
Secondary	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."	48 hours
Secondary	Postoperative complications	Assessment of the severity of the postoperative complications	48 hours and 30 days
Secondary	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.	Baseline and 3 months postoperatively
Secondary	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.	Baseline and 3 months postoperatively