Standardized Sleep Bundle for Cardiac Surgery Patients

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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 parti
• Другое 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.

Первичные конечные точки

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

Вторичные конечные точки (5)

• Total Sleep Duration [Срок оценки: Nightly from postoperative day 1 through postoperative day 5 or hospital discharge, whichever occurs first.]
• Nighttime Awakenings [Срок оценки: Nightly from postoperative day 1 through postoperative day 5 or until hospital discharge, whichever occurs first]
• Subjective Sleep Quality [Срок оценки: Each morning from postoperative day 1 through postoperative day 5 or until hospital discharge, whichever occurs first]
• Incidence of Postoperative Delirium [Срок оценки: Daily from postoperative day 1 through postoperative day 5 or until hospital discharge, whichever occurs first.]
• Hospital Length of Stay [Срок оценки: From day of surgery (postoperative day 0) through postoperative day 5 or until hospital discharge, whichever occurs first]

Критерии участия

Критерии включения

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

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Канада · 1 центр

• Saint John Regional Hospital — Saint John

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07401836 · 102398

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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