Actively Recruiting

Phase Not Applicable
Age: 19Years +
All Genders
NCT07401836

Standardized Sleep Bundle for Cardiac Surgery Patients

Led by Horizon Health Network · Updated on 2026-03-30

20

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

Sponsors

H

Horizon Health Network

Lead Sponsor

N

New Brunswick Heart Centre

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Standardized Sleep Bundle for Cardiac Surgery Patients

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients over 19 years old undergoing non-emergent cardiac surgery with cardiopulmonary bypass at Saint John Regional Hospital
Not Eligible

You will not qualify if you...

  • Emergent surgery
  • Severe kidney or liver impairment (creatinine clearance <30 mL/min, CKD stage 4 or higher, cirrhosis, ALT ≥ 3 times upper limit of normal)
  • Sleep apnea
  • Restless leg syndrome
  • Chronic insomnia with regular use of certain sleep medications prior to admission (trazodone, benzodiazepines, zopiclone, mirtazapine, quetiapine, tricyclic antidepressants)
  • Use of monoamine oxidase inhibitors in the past 14 days
  • Prolonged QT interval > 500ms or history of serious heart rhythm problems
  • History of dementia, alcohol, or opioid use disorder
  • Known intolerance to melatonin, trazodone, or quetiapine
  • Unable to provide informed consent
  • Radial artery harvest required preventing Fitbit placement
  • Prolonged intubation or sedation over 48 hours after surgery
  • Major surgical complications preventing participation (stroke, major bleeding, mechanical support, reoperation, open chest, pulmonary embolism, acute renal failure requiring dialysis)

AI-Screening

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Trial Site Locations

Total: 1 location

1

Saint John Regional Hospital

Saint John, New Brunswick, Canada, E2L 4L2

Actively Recruiting

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Research Team

C

Christopher W White, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Standardized Sleep Bundle for Cardiac Surgery Patients | DecenTrialz