Sleep Bundle for Cardiac Surgery Patients
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
* 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 Is on the Research Team?
Caroline E Fitzpatrick
Principal Investigator
Horizon Health Network
Are You a Good Fit for This Trial?
Adults over 19 years old scheduled for non-emergency heart surgery with cardiopulmonary bypass at Saint John Regional Hospital can join. The trial is testing if a 'sleep bundle' helps patients sleep better after surgery compared to usual care.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either the standardized sleep bundle or usual postoperative care
Follow-up
Participants are monitored for sleep quality and other clinical outcomes after treatment
Data Analysis
Data collected during the trial is analyzed to inform future studies
What Are the Treatments Tested in This Trial?
Interventions
- Standardized Sleep Bundle
Trial Overview
The study tests a 'sleep bundle' including sleep masks, ear plugs, noise machines, and stepwise use of sleep meds against standard post-op care. It checks if this improves sleep quality using daily questionnaires and Fitbit data.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants in this group will receive a standardized sleep management protocol combining non-pharmacological interventions and stepwise pharmacotherapy.
Participants randomized to the control group will receive usual postoperative care.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Horizon Health Network
Lead Sponsor
New Brunswick Heart Centre
Collaborator
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