Clinical trial NCT04398082: TRANslating Sleep Health Into QUaLity of Recovery (TRANQUiL) 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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sleep Disorder
Sleep Disturbance
Keywords: sleep
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
Collaborators: name: University Health Network, Toronto
First posted: 2020-05-21
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Quality of recovery-15 score at 48 hrs postoperatively
timeFrame: 48 hours postoperatively
measure: The diagnostic accuracy of each of the actigraphy derived measures
timeFrame: 48 hours postoperatively
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI) Scores
timeFrame: 3 months postoperatively
measure: Consensus Sleep Diary (CSD) Scores
timeFrame: 7 days prior surgery, 7 days, and 3 months postoperatively
measure: Functional Outcomes in Sleep Questionnaire (FOSQ)
timeFrame: 7 days prior surgery and 3 months postoperatively
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline and 3 months postoperatively
measure: Fluid Intake and Output
timeFrame: 48 hours
measure: Visual analogue pain scores (VAS)
timeFrame: 48 hours
measure: Postoperative complications
timeFrame: 48 hours and 30 days
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score
timeFrame: Baseline and 3 months postoperatively
measure: Epworth Sleepiness Scale (ESS)
timeFrame: Baseline and 3 months postoperatively
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital (University Health Network)
state: Ontario
Study officials:
affiliation: Women's College Hospital and Toronto Western Hospital, University Health Network
name: Mandeep Singh, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: