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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• Adult patients over 19 years old, undergoing non-emergent cardiac surgery with cardiopulmonary bypass at the Saint John Regional Hospital (SJRH).

Locations
Other Locations
Canada
Saint John Regional Hospital
RECRUITING
Saint John
Contact Information
Primary
Christopher W White, MD
Christopher.White@HorizonNB.ca
15066487782
Time Frame
Start Date: 2026-03-02
Estimated Completion Date: 2026-06
Participants
Target number of participants: 20
Treatments
Experimental: Sleep Bundle Group
Participants in this group will receive a standardized sleep management protocol combining non-pharmacological interventions and stepwise pharmacotherapy.
Active_comparator: Usual Post Operative Care
Participants randomized to the control group will receive usual postoperative care.
Related Therapeutic Areas
Sponsors
Leads: Horizon Health Network
Collaborators: New Brunswick Heart Centre

This content was sourced from clinicaltrials.gov