Standardized sleep bundle for adults having cardiac surgery

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

This test sees if giving a standard set of non-drug sleep aids plus a stepwise sleep medication plan helps adults recover better sleep while in the hospital after non-emergency cardiac surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Horizon Health Network (Academic / other)
• Locations: 1 site (Saint John, New Brunswick)
• Trial ID: NCT07401836 on ClinicalTrials.gov

What this trial studies

This pilot randomized controlled trial enrolls adults undergoing non-emergency cardiac surgery at Saint John Regional Hospital and randomizes them to a standardized sleep bundle or usual postoperative care. The sleep bundle combines non-pharmacological items (sleep mask, ear plugs, nightly noise machine) with a stepwise medication approach beginning with melatonin and adding trazodone or quetiapine if needed. Participants wear a Fitbit at night and complete the Richards-Campbell Sleep Questionnaire daily while research staff collect feasibility measures on recruitment, retention, and protocol adherence. Secondary outcomes include total sleep duration, nighttime awakenings, subjective sleep quality, postoperative delirium, and hospital length of stay, with analysis performed by a team member blinded to group allocation.

Who should consider this trial

Good fit: Adults aged 19 and over scheduled for non-emergent cardiac surgery with cardiopulmonary bypass at Saint John Regional Hospital who do not have excluded sleep disorders or significant organ dysfunction are the intended participants.

Not a fit: Patients with sleep apnea, restless leg syndrome, chronic preoperative use of pharmacologic sleep aids, severe kidney or liver impairment, dementia, substance use disorders, or prolonged QTc are excluded and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the bundle could help patients sleep better after surgery and might lower the risk of delirium and shorten hospital stays.

How similar studies have performed: Multicomponent sleep-bundle approaches in hospitalized and ICU patients have shown mixed but sometimes promising results for improving sleep and reducing delirium, while this particular protocol in cardiac surgery patients is being piloted.

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).

Where this trial is running

Saint John, New Brunswick

• Saint John Regional Hospital — Saint John, New Brunswick, Canada (Recruiting)

Study contacts

• Principal investigator: Caroline E Fitzpatrick — Horizon Health Network
• Study coordinator: Christopher W White, MD

Conditions Sleep; cardiovascular surgery; sleep