Can a Standardized Sleep Bundle Reduce Sleep Disruption After Cardiac Surgery: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Recruitment Rate
研究概览
简要总结
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:
- Can eligible participants be recruited and retained in the study?
- Can participants follow the study procedures, including using sleep aids and completing daily assessments?
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients over 19 years old, undergoing non-emergent cardiac surgery with cardiopulmonary bypass at the Saint John Regional Hospital (SJRH).
排除标准
- •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).
研究组 & 干预措施
Sleep Bundle Group
Participants in this group will receive a standardized sleep management protocol combining non-pharmacological interventions and stepwise pharmacotherapy.
干预措施: Standardized Sleep Protocol (Other)
Usual Post Operative Care
Participants randomized to the control group will receive usual postoperative care.
干预措施: Usual Post Operative Care (Other)
结局指标
主要结局
Recruitment Rate
时间窗: 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.
Retention Rate
时间窗: 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.
Protocol Adherence
时间窗: 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.
Fitbit Adherence
时间窗: 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.
Time to Reach Target Sample Size
时间窗: 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.
次要结局
- 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)
研究者
Caroline.Fitzpatrick
Principle Investigator
Horizon Health Network