Standardized Sleep Bundle for Cardiac Surgery Patients
ConditionSleep
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorHorizon Health Network
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients over 19 years old, undergoing non-emergent cardiac surgery with cardiopulmonary bypass at the Saint John Regional Hospital (SJRH).
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Standardized Sleep Protocol
Other interventionNon-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
Other interventionStandard 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.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Sleep Bundle GroupExperimental treatment 1 intervention
Group B: Usual Post Operative CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From first participant enrollment until last participant enrolled (approximately 8 weeks)2
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.
Time frame
From enrollment until hospital discharge for each participant ( approximately 5 days)3
Protocol Adherence
Proportion of daily study assessments completed by participants. Reported as a percentage of completed assessments out of total expected assessments.
Time frame
Daily from Day 1 of enrollment through hospital discharge (approximately 5 days)4
Fitbit Adherence
Number of nights the Fitbit is worn ( minimum 3 scheduled nights). Reported as count and percentage of participants meeting adherence criteria.
Time frame
Each night from Day 1 of enrollment through hospital discharge (approximately 5 days)Secondary outcomes
1
Total Sleep Duration
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.
Time frame
Nightly from postoperative day 1 through postoperative day 5 or hospital discharge, whichever occurs first.2
Nighttime Awakenings
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.
Time frame
Nightly from postoperative day 1 through postoperative day 5 or until hospital discharge, whichever occurs first3
Subjective Sleep Quality
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.
Time frame
Each morning from postoperative day 1 through postoperative day 5 or until hospital discharge, whichever occurs first4
Incidence of Postoperative Delirium
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.
Time frame
Daily from postoperative day 1 through postoperative day 5 or until hospital discharge, whichever occurs first.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Horizon Health Network
Lead sponsor
New Brunswick Heart Centre
Collaborator
Source ClinicalTrials.gov