NCT07401836

Standardized Sleep Bundle for Cardiac Surgery Patients

Can a Standardized Sleep Bundle Reduce Sleep Disruption After Cardiac Surgery: A Pilot Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Horizon Health Network · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a pilot randomized controlled trial designed to evaluate the feasibility and effects of a standardized sleep bundle on sleep quality in patients undergoing cardiac surgery. Adult patients scheduled for non-emergent cardiac surgery at the Saint John Regional Hospital (SJRH) will be screened for eligibility and enrolled after providing informed consent. Participants will be randomized to either usual postoperative care or the sleep bundle group. The sleep bundle includes non-pharmacological interventions (sleep mask, ear plugs, nightly noise machine) and a stepwise pharmacological approach (melatonin, with trazodone or quetiapine added as needed). Sleep outcomes will be measured objectively using the Fitbit Inspire 3 device and subjectively using the Richards-Campbell Sleep Questionnaire (RCSQ). Feasibility will be assessed based on recruitment, retention, and adherence to the study protocol. Secondary outcomes include total sleep duration, nighttime awakenings, subjective sleep quality, incidence of postoperative delirium, and hospital length of stay. All study procedures and daily assessments will be conducted by trained research personnel, with data analysis performed by a team member blinded to group allocation. This pilot study will inform the design of a future larger-scale trial.

Conditions

• Sleep

Interventions

Type	Name	Description
OTHER	Standardized Sleep Protocol	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
OTHER	Usual Post Operative Care	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.

Timeline

• Start date: 2026-03-02
• Primary completion: 2026-05-29
• Completion: 2026-06-01
• First posted: 2026-02-11
• Last updated: 2026-03-30

Locations

1 site across 1 country: Canada