Eye-Ear Sleep Band for Sleep Quality in Coronary Care Unit (EESQ-CCU)

March 22, 2026 updated by: Meryem Ayvaz, Koç University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental first (Eye-ear sleep band → Standard care)
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.
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.
Active Comparator: Control First (Standard Care → Eye-Ear Sleep Band)
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1 and Day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Koç University

Investigators

  • Study Chair: Nuray Enç, Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing, Istanbul, Turkey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2019

Primary Completion (Actual)

November 1, 2019

Study Completion (Actual)

November 1, 2019

Study Registration Dates

First Submitted

March 17, 2026

First Submitted That Met QC Criteria

March 22, 2026

First Posted (Actual)

March 24, 2026

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 22, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10/05/2018-171740

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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