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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental first (Eye-ear sleep band → Standard care) | Experimental | Participants received the eye-ear sleep band on Night 1 followed by standard CCU care on Night 2. The eye-ear sleep band is an integrated, adjustable, antibacterial product combining an eye mask and earplugs in a single unit, applied by the principal investigator at 22:00. |
|
| Control First (Standard Care → Eye-Ear Sleep Band) | Active Comparator | Participants received standard CCU care on Night 1 followed by the eye-ear sleep band on Night 2. Standard care consisted of routine nursing care without any sleep-promoting product. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eye-Ear Sleep Band | Other | An integrated, adjustable, antibacterial product combining an eye mask and earplugs in a single unit, designed to block both light and noise simultaneously. The band was designed by the principal investigator. It was applied by the principal investigator at 22:00 on the intervention night and worn until spontaneous awakening. Compliance was monitored via video recording throughout the night. |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Quality | 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. | Day 1 and Day 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nuray Enç | Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing, Istanbul, Turkey | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Koç University | Istanbul | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D012892 | Sleep Deprivation |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Standard CCU Care | Other | Routine nursing care provided in the coronary care unit, including continuous cardiac monitoring, vital sign assessment, and medication administration as clinically indicated. No sleep-promoting product, eye mask, or earplugs were used. The sleep period was standardised to commence at 22:00, consistent with the intervention night. |
|
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |