Standardized Sleep Bundle for Cardiac Surgery Patients

NCT07401836 | Recruiting

• 1 other identifier: 102398
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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:

• 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

Keywords

cardiovascular surgery; sleep

Outcome Measures

Primary Outcomes (5)

• Recruitment Rate

  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

  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

  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

  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

  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 Outcomes (5)

• Total Sleep Duration

  Nightly from postoperative day 1 through postoperative day 5 or hospital discharge, whichever occurs first.

• Nighttime Awakenings

  Nightly from postoperative day 1 through postoperative day 5 or until hospital discharge, whichever occurs first

• Subjective Sleep Quality

  Each morning from postoperative day 1 through postoperative day 5 or until hospital discharge, whichever occurs first

• Incidence of Postoperative Delirium

  Daily from postoperative day 1 through postoperative day 5 or until hospital discharge, whichever occurs first.

• Hospital Length of Stay

  From day of surgery (postoperative day 0) through postoperative day 5 or until hospital discharge, whichever occurs first

Study Arms (2)

Sleep Bundle Group

EXPERIMENTAL

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

Other: Standardized Sleep Protocol

Usual Post Operative Care

ACTIVE COMPARATOR

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

Other: Usual Post Operative Care

Interventions

Standardized Sleep Protocol OTHER

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

Sleep Bundle Group

Usual Post Operative Care OTHER

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.

Usual Post Operative Care

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients over 19 years old, undergoing non-emergent cardiac surgery with cardiopulmonary bypass at the Saint John Regional Hospital (SJRH).

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Horizon Health Network: lead
• New Brunswick Heart Centre: collaborator

Study Sites (1)

Saint John Regional Hospital

Saint John, New Brunswick, E2L 4L2, Canada

RECRUITING

Related Publications (8)

• Elliott R, Axelin A, Richards KC, Vahlberg T, Ritmala-Castren M. Sensitivity and specificity of proposed Richards-Campbell Sleep Questionnaire cut-off scores for good quality sleep during an ICU stay. J Clin Nurs. 2023 Jun;32(11-12):2700-2708. doi: 10.1111/jocn.16348. Epub 2022 May 15.

  PMID: 35570380 BACKGROUND

• Haghayegh S, Khoshnevis S, Smolensky MH, Diller KR, Castriotta RJ. Accuracy of Wristband Fitbit Models in Assessing Sleep: Systematic Review and Meta-Analysis. J Med Internet Res. 2019 Nov 28;21(11):e16273. doi: 10.2196/16273.

  PMID: 31778122 BACKGROUND

• Soh PQP, Wong WHT, Roy T, Tam WWS. Effectiveness of non-pharmacological interventions in improving sleep quality after cardiac surgery: A systematic review and meta-analysis. J Clin Nurs. 2024 Jun;33(6):2084-2098. doi: 10.1111/jocn.17115. Epub 2024 Mar 13.

  PMID: 38477050 BACKGROUND

• Mahran GS, Leach MJ, Abbas MS, Abbas AM, Ghoneim AM. Effect of Eye Masks on Pain and Sleep Quality in Patients Undergoing Cardiac Surgery: A Randomized Controlled Trial. Crit Care Nurse. 2020 Feb 1;40(1):27-35. doi: 10.4037/ccn2020709.

  PMID: 32006033 BACKGROUND

• Liao WC, Huang CY, Huang TY, Hwang SL. A systematic review of sleep patterns and factors that disturb sleep after heart surgery. J Nurs Res. 2011 Dec;19(4):275-88. doi: 10.1097/JNR.0b013e318236cf68.

  PMID: 22089653 BACKGROUND

• Simeone S, Pucciarelli G, Perrone M, Teresa R, Gargiulo G, Guillari A, Castellano G, Tommaso LD, Niola M, Iannelli G. Delirium in ICU patients following cardiac surgery: An observational study. J Clin Nurs. 2018 May;27(9-10):1994-2002. doi: 10.1111/jocn.14324. Epub 2018 Apr 25.

  PMID: 29493837 BACKGROUND

• Zhang WY, Wu WL, Gu JJ, Sun Y, Ye XF, Qiu WJ, Su CQ, Zhang SQ, Ye WQ. Risk factors for postoperative delirium in patients after coronary artery bypass grafting: A prospective cohort study. J Crit Care. 2015 Jun;30(3):606-12. doi: 10.1016/j.jcrc.2015.02.003. Epub 2015 Feb 7.

  PMID: 25708120 BACKGROUND

• Caruana N, McKinley S, Elliott R, Gholizadeh L. Sleep Quality During and After Cardiothoracic Intensive Care and Psychological Health During Recovery. J Cardiovasc Nurs. 2018 Jul/Aug;33(4):E40-E49. doi: 10.1097/JCN.0000000000000499.

  PMID: 29771744 BACKGROUND

Study Officials

• Caroline E Fitzpatrick

  Horizon Health Network

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher W White, MD

CONTACT

15066487782; Christopher.White@HorizonNB.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Prospective pilot randomized controlled study with a parallel group design comparing a sleep bundle intervention to usual postoperative care, with feasibility as the primary outcome.

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: February 11, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): May 29, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

CA (1)