Standardized Sleep Bundle for Cardiac Surgery Patients
Can a Standardized Sleep Bundle Reduce Sleep Disruption After Cardiac Surgery: A Pilot Randomized Controlled Trial
Horizon Health Network
20 participants
Mar 2, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria1
- Adult patients over 19 years old, undergoing non-emergent cardiac surgery with cardiopulmonary bypass at the Saint John Regional Hospital (SJRH).
Exclusion Criteria14
- 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 ischemic attach (TIA), major bleeding, need for mechanical/circulatory support, reoperation, open chest, pulmonary embolism, acute renal failure requiring dialysis or other major surgical complications that would inhibit ability to participate).
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Interventions
Non-Pharmacological Sleep Aids * All participants will be encouraged to wear a sleep mask and ear plugs nightly. In addition, a noise machine will be provided each night, the content and volume of which will be decided by the patient. * Stepwise Pharmacotherapy Approach Step 1: Melatonin \- Melatonin 6 mg orally at bedtime will be initiated for all participants in the sleep bundle group. Step 2: Adjunctive Therapy (Trazodone) * If the participants daily RCSQ score is below 63.4 or the participant reports inadequate sleep despite melatonin, trazodone will be scheduled orally at bedtime. * Trazodone will start at 25 mg and may be increased in 25 mg increments up to 100 mg orally at bedtime, based on participant response and tolerability. Step 3: Escalation for Delirium (Quetiapine) * If the participant has documented postoperative delirium, quetiapine 12.5 mg immediate release oral tablet will be scheduled at bedtime. * Dose may be increased in 12.5 mg increments up to 100 mg as cli
Standard postoperative care without the structured sleep bundle. This includes routine clinical management of sleep without non-pharmacological interventions or protocolized pharmacological sleep aid. Any sleep medications administered will be at the discretion of the care team, without a standardized approach, reflecting standard practice.
Locations(1)
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NCT07401836