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Completed

NCT Number: NCT07490743

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

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.

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Key information

Conditions

Acute Coronary Syndromes (ACS) Acute Coronary Syndrome Cardiovascular Diseases Dyssomnias Heart Diseases Mental Disorders Myocardial Ischemia Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Deprivation Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Quality Sleep Wake Disorders Vascular Diseases

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Koç University

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 25-65 years
  • Admitted to the coronary care unit with a diagnosis of acute coronary syndrome
  • Not receiving sedation or invasive mechanical ventilation

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Sleep Quality

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Koç University

Other

Registry information

Official study title

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

Acronym: EESQ-CCU

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 24, 2026
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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