Improving Sleep Quality in Coronary Care Unit Patients With an Eye-Ear Sleep Band: A Crossover Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Sleep Quality
研究概览
简要总结
Sleep disturbances are common in patients admitted to the coronary care unit (CCU), where continuous light, noise, and monitoring equipment disrupt normal sleep. Poor sleep in CCU patients can worsen heart function and increase the risk of delirium.
This study tested whether wearing an eye-ear sleep band, a single, adjustable product that blocks both light and noise, could improve sleep quality in CCU patients compared to standard care alone.
One hundred adults admitted to the CCU with acute coronary syndrome were enrolled. Using a crossover design, each participant spent one night wearing the eye-ear sleep band and one night receiving standard CCU care, in a randomly assigned order. Sleep quality was measured each morning using a validated questionnaire (Richards-Campbell Sleep Questionnaire).
The eye-ear sleep band is a simple, low-cost, non-pharmacological tool that may help improve sleep in CCU patients.
详细描述
This crossover randomised controlled trial was conducted between May and November 2019 in the 12-bed coronary care unit (CCU) of a university-affiliated hospital in Istanbul, Turkey.
Eligible patients were adults admitted with acute coronary syndrome who were haemodynamically stable and expected to remain in the CCU for at least two consecutive nights. Patients with a known sleep disorder, high risk for obstructive sleep apnoea (Berlin Questionnaire), or current use of pharmacological sleep aids were excluded.
Participants were randomised into two sequence groups: Group 1 (n=53) received the eye-ear sleep band on Night 1 and standard care on Night 2; Group 2 (n=47) received standard care on Night 1 and the eye-ear sleep band on Night 2. The eye-ear sleep band is an integrated, adjustable, antibacterial material combining an eye mask and earplugs in a single unit. It was applied by the principal investigator at 22:00 on the intervention night. Compliance was verified via video recording.
Sleep quality was assessed each morning upon spontaneous awakening using the Richards-Campbell Sleep Questionnaire (RCSQ), a validated visual analogue scale instrument. Single masking was applied at the outcome assessment level. Period and carryover effects were examined prior to primary analysis; neither was statistically significant. Data were analysed using within-group and between-group comparisons, and a multiple regression model was used to identify predictors of sleep quality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 25-65 years
- •Admitted to the coronary care unit with a diagnosis of acute coronary syndrome
- •Not receiving sedation or invasive mechanical ventilation
排除标准
- •Pre-existing sleep disorder
- •High risk for obstructive sleep apnoea, indicated by a positive score on two or more categories of the Berlin Questionnaire
- •Current use of pharmacological sleep aids
- •Habitual use of an eye mask during sleep
- •Baseline pain score of 7 or above on the Visual Analogue Scale (VAS)
- •Documented hearing or visual impairment, or current use of a hearing aid
- •Requirement for invasive mechanical ventilation
- •Receipt of general anaesthesia within the preceding 12 hours
结局指标
主要结局
Sleep Quality
时间窗: Day 1 and Day 2
Sleep quality was assessed using the Richards-Campbell Sleep Questionnaire (RCSQ), a validated self-report instrument comprising five visual analogue scale items (sleep depth, falling asleep, awakening frequency, returning to sleep, and overall sleep quality). Each item is scored from 0 to 100; a total score below 50 indicates poor sleep quality.
次要结局
未报告次要终点
研究者
Meryem Ayvaz
Assistant Professor
Koç University