Recruiting

Sleep Bundle

Sponsor:

Horizon Health Network

Code:

NCT07401836

Conditions

Sleep

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Standardized Sleep Protocol

Usual Post Operative Care

Study Details

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.

Conditions

Sleep

Study ID

NCT07401836

Start date

Mar 2, 2026

Status verified date

Mar, 2026

Completion date

Jun, 2026

Anticipated

Primary completion date

May 29, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Sleep Bundle Group

Participants in this group will receive a standardized sleep management protocol combining non-pharmacological interventions and stepwise pharmacotherapy.

active comparator: Usual Post Operative Care

Participants randomized to the control group will receive usual postoperative care.

Interventions

Standardized Sleep Protocol

Non-Pharmacological Sleep Aids

  • All participants will be encouraged to wear a sleep mask and ear plugs nightly. In addition, a noise machine will be provided each night, the content and volume of which will be decided by the patient.
  • Stepwise Pharmacotherapy Approach

Step 1: Melatonin

\- Melatonin 6 mg orally at bedtime will be initiated for all participants in the sleep bundle group.

Step 2: Adjunctive Therapy (Trazodone)

  • If the participants daily RCSQ score is below 63.4 or the participant reports inadequate sleep despite melatonin, trazodone will be scheduled orally at bedtime.
  • Trazodone will start at 25 mg and may be increased in 25 mg increments up to 100 mg orally at bedtime, based on participant response and tolerability.

Step 3: Escalation for Delirium (Quetiapine)

  • If the participant has documented postoperative delirium, quetiapine 12.5 mg immediate release oral tablet will be scheduled at bedtime.
  • Dose may be increased in 12.5 mg increments up to 100 mg as cli

Usual Post Operative Care

Standard postoperative care without the structured sleep bundle. This includes routine clinical management of sleep without non-pharmacological interventions or protocolized pharmacological sleep aid. Any sleep medications administered will be at the discretion of the care team, without a standardized approach, reflecting standard practice.

Primary outcome measure

  • Recruitment Rate [ Time Frame: From first participant enrollment until last participant enrolled (approximately 8 weeks) ]
  • Retention Rate [ Time Frame: From enrollment until hospital discharge for each participant ( approximately 5 days) ]
  • Protocol Adherence [ Time Frame: Daily from Day 1 of enrollment through hospital discharge (approximately 5 days) ]
  • Fitbit Adherence [ Time Frame: Each night from Day 1 of enrollment through hospital discharge (approximately 5 days) ]
  • Time to Reach Target Sample Size [ Time Frame: From first participant enrolment to enrolment of the 20th participant ( approximately 8 weeks) ]

Central Contacts and Locations

Central contacts

Christopher W White, MD

15066487782Christopher.White@HorizonNB.ca

Locations

Saint John Regional Hospital

Recruiting

Saint John, New Brunswick, Canada, E2L 4L2

More Information

Sponsor

Horizon Health Network

Last update posted

Mar 30, 2026

Last verified

Mar, 2026

Keywords

  • cardiovascular surgery
  • sleep

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Horizon Health Network on 2026-03-30.