Clinical Trial

Standardized Sleep Bundle for Cardiac Surgery Patients

Recruiting
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Record status
This record was last updated March 30, 2026 (before its estimated May 29, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 changes
critical Recruitment opened 2026-03-31
notable Primary completion pushed: 2026-04-17 -> 2026-05-29 2026-03-31
Trial Details
NCT Number NCT07401836
Lead Sponsor Horizon Health Network
Collaborators: New Brunswick Heart Centre
Conditions Sleep
Enrollment 20 participants
Start Date 2026-03-02
Primary Completion 2026-05-29 (estimated)
Study Completion 2026-06 (estimated)
Updated on ClinicalTrials.gov 2026-03-30