Standardized Sleep Bundle for Cardiac Surgery Patients

March 27, 2026 updated by: Caroline.Fitzpatrick, Horizon Health Network

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a pilot randomized controlled trial designed to evaluate the feasibility and effects of a standardized sleep bundle on sleep quality in patients undergoing cardiac surgery. Adult patients scheduled for non-emergent cardiac surgery at the Saint John Regional Hospital (SJRH) will be screened for eligibility and enrolled after providing informed consent. Participants will be randomized to either usual postoperative care or the sleep bundle group.

The sleep bundle includes non-pharmacological interventions (sleep mask, ear plugs, nightly noise machine) and a stepwise pharmacological approach (melatonin, with trazodone or quetiapine added as needed). Sleep outcomes will be measured objectively using the Fitbit Inspire 3 device and subjectively using the Richards-Campbell Sleep Questionnaire (RCSQ). Feasibility will be assessed based on recruitment, retention, and adherence to the study protocol. Secondary outcomes include total sleep duration, nighttime awakenings, subjective sleep quality, incidence of postoperative delirium, and hospital length of stay.

All study procedures and daily assessments will be conducted by trained research personnel, with data analysis performed by a team member blinded to group allocation. This pilot study will inform the design of a future larger-scale trial.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L2
        • Recruiting
        • Saint John Regional Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sleep Bundle Group
Participants in this group will receive a standardized sleep management protocol combining non-pharmacological interventions and stepwise pharmacotherapy.
Other: 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
Active Comparator: Usual Post Operative Care
Participants randomized to the control group will receive usual postoperative care.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment Rate
Time Frame: From first participant enrollment until last participant enrolled (approximately 8 weeks)
Proportion of eligible patients who consent to participate in the study. Recruitment success is defined as greater than 50% of eligible patients enrolled. Reported as a percentage.
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)
Proportion of participants who complete the study. Retention success is defined as greater than 80% of participants completing the study. Reported as a percentage.
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)
Proportion of daily study assessments completed by participants. Reported as a percentage of completed assessments out of total expected assessments.
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)
Number of nights the Fitbit is worn ( minimum 3 scheduled nights). Reported as count and percentage of participants meeting adherence criteria.
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)
Number of days required to enroll the target sample size of 20 participants. Reported in days.
From first participant enrolment to enrolment of the 20th participant ( approximately 8 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Sleep Duration
Time Frame: Nightly from postoperative day 1 through postoperative day 5 or hospital discharge, whichever occurs first.
Objective sleep duration will be measured using the Fitbit Inspire 3 device, worn on the wrist contralateral to the radial arterial line. The device records total sleep time nightly between 9:00 PM and 9:00 AM. Data will be summarized using daily means, standard deviations, medians, and interquartile ranges.
Nightly from postoperative day 1 through postoperative day 5 or hospital discharge, whichever occurs first.
Nighttime Awakenings
Time Frame: Nightly from postoperative day 1 through postoperative day 5 or until hospital discharge, whichever occurs first
Objective nighttime awakenings will be measured using the Fitbit Inspire 3 device, recorded nightly between 9:00 PM and 9:00 AM. Daily counts of awakenings will be summarized using means, standard deviations, medians, and interquartile ranges.
Nightly from postoperative day 1 through postoperative day 5 or until hospital discharge, whichever occurs first
Subjective Sleep Quality
Time Frame: Each morning from postoperative day 1 through postoperative day 5 or until hospital discharge, whichever occurs first
Subjective sleep quality will be assessed each morning using the Richards-Campbell Sleep Questionnaire (RCSQ), a validated 0-100 mm visual analog scale evaluating sleep depth, latency, awakenings, efficiency, and overall quality. Scores will be averaged across the five domains. Daily scores will be summarized using descriptive statistics.
Each morning from postoperative day 1 through postoperative day 5 or until hospital discharge, whichever occurs first
Incidence of Postoperative Delirium
Time Frame: Daily from postoperative day 1 through postoperative day 5 or until hospital discharge, whichever occurs first.
Incidence of delirium will be recorded based on daily assessments documented by the care team in patient charts. Counts and percentages of participants experiencing delirium will be reported.
Daily from postoperative day 1 through postoperative day 5 or until hospital discharge, whichever occurs first.
Hospital Length of Stay
Time Frame: From day of surgery (postoperative day 0) through postoperative day 5 or until hospital discharge, whichever occurs first
Length of stay will be recorded in days from the date of surgery to the date of discharge, as documented in the patient's medical record. Data will be summarized using descriptive statistics.
From day of surgery (postoperative day 0) through postoperative day 5 or until hospital discharge, whichever occurs first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Horizon Health Network

Collaborators

New Brunswick Heart Centre

Investigators

  • Principal Investigator: Caroline E Fitzpatrick, Horizon Health Network

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2026

Primary Completion (Estimated)

May 29, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

January 19, 2026

First Submitted That Met QC Criteria

February 6, 2026

First Posted (Actual)

February 11, 2026

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 102398

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The decision to share individual participant data has not yet been determined. Plans for data sharing will be considered once the feasibility and outcomes of the pilot study are evaluated.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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