NCT07401836 Standardized Sleep Bundle for Cardiac Surgery Patients
| NCT ID | NCT07401836 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Horizon Health Network |
| Condition | Sleep |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-03-02 |
| Primary Completion | 2026-05-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2026-03-02 with a primary completion date of 2026-05-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * Adult patients over 19 years old, undergoing non-emergent cardiac surgery with cardiopulmonary bypass at the Saint John Regional Hospital (SJRH). Exclusion Criteria: * 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). * Insomnia with chronic use of pharmacological sleep aids prior to admission (trazodone, benzodiazepines, zopiclone, mirtazapine, quetiapine, tricyclic antidepressants \[nortriptyline, amitriptyline, doxepin\]). * Prior use of a monoamine oxidase inhibitor in the past 14 days. * Corrected QT Interval (QTc) \> 500ms / history of prolonged QTc, Torsade de points or ventricular tachycardia. * History of dementia, alcohol, or opioid use disorder. * Documented or previous intolerance to melatonin, trazodone, or quetiapine. Unable to provide informed consent. Run-in Period Exclusions: After enrolment and before randomization, participants will be monitored for specific postoperative criteria. Those meeting any of the following criteria will be withdrawn prior to randomization. * Radial artery harvest required (unable to place Fitbit device on the wrist contralateral to the arterial monitoring line). * Prolonged intubation or sedation (\> 48 hours) post-surgery. * Major intra- or early postoperative complications (stroke, transient ischemic attach (TIA), major bleeding, need for mechanical/circulatory support, reoperation, open chest, pulmonary embolism, acute renal failure requiring dialysis or other major surgical complications that would inhibit ability to participate).
Contact & Investigator
Caroline E Fitzpatrick
PRINCIPAL INVESTIGATOR
Horizon Health Network
Frequently Asked Questions
Who can join the NCT07401836 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Sleep. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07401836 currently recruiting?
Yes, NCT07401836 is actively recruiting participants. Contact the research team at Christopher.White@HorizonNB.ca for enrollment information.
Where is the NCT07401836 trial being conducted?
This trial is being conducted at Saint John, Canada.
Who is sponsoring the NCT07401836 clinical trial?
NCT07401836 is sponsored by Horizon Health Network. The principal investigator is Caroline E Fitzpatrick at Horizon Health Network. The trial plans to enroll 20 participants.