RecruitingNot Applicable

Standardized Sleep Bundle for Cardiac Surgery Patients

Canada20 participantsStarted 2026-03-02

Plain-language summary

The goal of this clinical trial is to evaluate the feasibility of using a standardized sleep bundle in adults undergoing cardiac surgery. The main questions it aims to answer are: 1. Can eligible participants be recruited and retained in the study? 2. Can participants follow the study procedures, including using sleep aids and completing daily assessments? 3. Can sleep and other clinical data be reliably collected during the hospital stay? Researchers will compare participants who receive the sleep bundle to participants who receive usual postoperative care. Participants will: * Use non-drug sleep aids, including a sleep mask, ear plugs, and a noise machine (sleep bundle group only). * Take sleep medications if needed, following a stepwise protocol (sleep bundle group only). * Complete daily sleep assessments using the Richards-Campbell Sleep Questionnaire (RCSQ). * Wear a Fitbit device at night to track sleep. * Follow usual postoperative care routines (control group) The study will also collect and describe data on sleep duration, nighttime awakenings, subjective sleep quality, incidence of postoperative delirium, and hospital length of stay to inform the design of a future larger trial.

Who can participate

Age range19 Years

SexALL

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Inclusion Criteria: * Adult patients over 19 years old, undergoing non-emergent cardiac surgery with cardiopulmonary bypass at the Saint John Regional Hospital (SJRH). Exclusion Criteria: * Emergent surgery. * Severe renal or hepatic impairment (creatinine clearance (CrCl) \<30 mL/min, Chronic Kidney Disease (CKD) stage ≥4, cirrhosis, Alanine Transaminase (ALT) ≥ 3 × upper limit of normal (ULN)). * Sleep apnea. * Restless leg syndrome (RLS). * Insomnia with chronic use of pharmacological sleep aids prior to admission (trazodone, benzodiazepines, zopiclone, mirtazapine, quetiapine, tricyclic antidepressants \[nortriptyline, amitriptyline, doxepin\]). * Prior use of a monoamine oxidase inhibitor in the past 14 days. * Corrected QT Interval (QTc) \> 500ms / history of prolonged QTc, Torsade de points or ventricular tachycardia. * History of dementia, alcohol, or opioid use disorder. * Documented or previous intolerance to melatonin, trazodone, or quetiapine. Unable to provide informed consent. Run-in Period Exclusions: After enrolment and before randomization, participants will be monitored for specific postoperative criteria. Those meeting any of the following criteria will be withdrawn prior to randomization. * Radial artery harvest required (unable to place Fitbit device on the wrist contralateral to the arterial monitoring line). * Prolonged intubation or sedation (\> 48 hours) post-surgery. * Major intra- or early postoperative complications (stroke, transient ischemi…

What they're measuring

Recruitment Rate

Timeframe: From first participant enrollment until last participant enrolled (approximately 8 weeks)

Retention Rate

Timeframe: From enrollment until hospital discharge for each participant ( approximately 5 days)

Protocol Adherence

Timeframe: Daily from Day 1 of enrollment through hospital discharge (approximately 5 days)

Fitbit Adherence

Timeframe: Each night from Day 1 of enrollment through hospital discharge (approximately 5 days)

Time to Reach Target Sample Size

Timeframe: From first participant enrolment to enrolment of the 20th participant ( approximately 8 weeks)

Trial details

NCT IDNCT07401836

SponsorHorizon Health Network

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-29

Contact for this trial

Christopher W White, MD

15066487782 Christopher.White@HorizonNB.ca

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