Acute Coronary Syndromes (ACS)EESQ-CCUNCT07490743
Eye-Ear Sleep Band for Sleep Quality in Coronary Care Unit
A study testing Eye-Ear Sleep Band and Standard CCU Care in people with Acute Coronary Syndromes (ACS) and Sleep Quality, run by Koç University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Acute Coronary Syndromes (ACS), Sleep Quality, Sleep Deprivation
- What is being tested?
- Eye-Ear Sleep Band and Standard CCU Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2019to 1 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 25-65 years
- Admitted to the coronary care unit with a diagnosis of acute coronary syndrome
- Not receiving sedation or invasive mechanical ventilation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Eye-Ear Sleep Band, Standard CCU Care
- Keywords
- acute coronary syndrome, sleep quality, coronary care unit, non-pharmacological intervention, eye-ear sleep band, earplugs, eye mask, randomised controlled trial, crossover design
- Medical subject headings
- Acute Coronary Syndrome, Sleep Initiation and Maintenance Disorders, Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye-Ear Sleep BandOther
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Standard CCU Care |
| 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. Receives: Other: Eye-Ear Sleep Band |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 and Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start1 May 2019
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary Syndromes (ACS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meryem Ayvaz, Koç University
- Investigators
- Nuray Enç, Study chair, Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing, Istanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490743
- Sponsor's protocol ID
- 10/05/2018-171740
- Acronym
- EESQ-CCU
- Status last verified
- Mar 2026
- First submitted
- 17 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Sleep Quality in Coronary Care Unit Patients With an Eye-Ear Sleep Band: A Crossover Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07490743
- Acronym / sponsor ID
- EESQ-CCU / 10/05/2018-171740
- Keywords
- acute coronary syndrome, sleep quality, coronary care unit, non-pharmacological intervention, eye-ear sleep band, earplugs, eye mask, randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental first (Eye-ear sleep band → Standard care) | Experimental | Other: Standard CCU CareParticipants 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 | Other: Eye-Ear Sleep BandParticipants 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. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 25-65 years
- Admitted to the coronary care unit with a diagnosis of acute coronary syndrome
- Not receiving sedation or invasive mechanical ventilation
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye-Ear Sleep BandAn 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 | Control First (Standard Care → Eye-Ear Sleep Band) |
| Standard CCU CareRoutine 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. | Other | Experimental first (Eye-ear sleep band → Standard care) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nuray Enç study chair
Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing, Istanbul, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye-Ear Sleep Band and Standard CCU Care in people with Acute Coronary Syndromes (ACS) and Sleep Quality, run by Koç University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality (time frame: Day 1 and Day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.