NCT07490743

Eye-Ear Sleep Band for Sleep Quality in Coronary Care Unit

Improving Sleep Quality in Coronary Care Unit Patients With an Eye-Ear Sleep Band: A Crossover Randomised Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Koç University · Academic / Other
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Acute Coronary Syndromes (ACS)
• Sleep Quality
• Sleep Deprivation

Interventions

Type	Name	Description
OTHER	Eye-Ear Sleep Band	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.
OTHER	Standard CCU Care	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.

Timeline

• Start date: 2019-05-01
• Primary completion: 2019-11-01
• Completion: 2019-11-01
• First posted: 2026-03-24
• Last updated: 2026-03-24

Locations

1 site across 1 country: Turkey (Türkiye)