Standardized Sleep Bundle for Cardiac Surgery Patients

ConditionSleep
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorHorizon Health Network

About 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 (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 criteria

Qualifiers

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

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Standardized Sleep Protocol
  • Usual Post Operative Care

Treatment groups

20 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Horizon Health Network

Lead sponsor

New Brunswick Heart Centre

Collaborator