Sleep DisturbanceNCT07385768
Effect of an Eye Mask-Based Blackout Protocol on Sleep Quality and Melatonin
A study testing Eye Mask-Based Blackout Protocol in people with Sleep Disturbance and Circadian Rhythm Sleep Disorders, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Sleep disturbance is a common problem among patients hospitalized in intensive care units due to continuous light exposure, noise, and frequent medical interventions. Disruption of the normal day-night cycle may reduce melatonin secretion and negatively affect sleep quality and recovery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sleep Disturbance, Circadian Rhythm Sleep Disorders, Intensive Care Unit Patients
- What is being tested?
- Eye Mask-Based Blackout Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2024to 1 Jun 2025
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 18 years and older
- Patients admitted to the intensive care unit
- Patients expected to remain in the intensive care unit for at least 24 hours
- Patients with the ability to tolerate an eye mask during nighttime sleep
- Patients or their legal representatives who provided informed consent
Who cannot join
- Patients with facial trauma, eye injury, or ophthalmologic conditions preventing eye mask use
- Patients receiving continuous deep sedation
- Patients with severe cognitive impairment or delirium preventing cooperation
- Patients with diagnosed sleep disorders prior to intensive care admission
- Patients who refused to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Atatürk University Faculty of Nursing
Erzurum, Erzurum, 25000
About this study
Official title: The Effect of an Eye Mask-Based Blackout Protocol on Patients' Sleep Quality and Melatonin Levels: A Randomised Controlled Trial
Sleep disturbance is a common problem among patients hospitalized in intensive care units due to continuous light exposure, noise, and frequent medical interventions. Disruption of the normal day-night cycle may reduce melatonin secretion and negatively affect sleep quality and recovery.
This randomized controlled study aimed to evaluate the effect of an eye mask-based blackout protocol on sleep quality and melatonin levels in patients hospitalized in a chest intensive care unit. Participants were randomly assigned to either an intervention group or a control group. Patients in the intervention group wore a lightproof eye mask during nighttime hours (11:00 p.m. to 05:00 a.m.) in addition to standard light-reduction practices, while the control group received routine intensive care.
Sleep quality was assessed using validated subjective scales, and melatonin levels were evaluated by measuring urinary 6-sulfatoxymelatonin. The study sought to determine whether reducing nighttime light exposure using a simple, non-invasive intervention could improve sleep quality and support circadian rhythm regulation in intensive care patients.
Read the detailed description
This study was designed as a randomized controlled trial to investigate the effect of an eye mask-based blackout protocol on sleep quality and melatonin levels in patients hospitalized in a chest intensive care unit.
The study was conducted at a university research hospital in Turkey. Eligible adult patients who were conscious, breathing spontaneously, and able to provide informed consent were randomly assigned to either an intervention group or a control group using a 1:1 allocation ratio. Patients receiving mechanical ventilation or using medications affecting melatonin secretion were excluded.
Participants in the intervention group wore a lightproof eye mask between 11:00 p.m. and 05:00 a.m. for two consecutive nights. In addition to eye mask use, nighttime lighting in the patient's room was minimized according to a standardized protocol. The control group received routine intensive care without any additional light-reduction intervention.
Sleep quality was evaluated using the Visual Analogue Scale for Sleep Quality and the Richard Campbell Sleep Scale. Melatonin secretion was assessed by measuring urinary 6-sulfatoxymelatonin levels collected overnight. Urine samples were stored under controlled conditions and analyzed using an enzyme-linked immunosorbent assay (ELISA).
The primary objective of the study was to determine whether the eye mask-based blackout protocol improved subjective sleep quality. A secondary objective was to assess changes in melatonin levels as a biological marker of circadian rhythm regulation.
All procedures were conducted in accordance with the Declaration of Helsinki. Ethical approval was obtained from the relevant institutional ethics committee, and written informed consent was obtained from all participants prior to enrollment.
- Being tested
- Eye Mask-Based Blackout Protocol
- Keywords
- Eye mask, Light exposure, Melatonin, Sleep quality, Intensive care unit
- Medical subject headings
- Parasomnias, Sleep Disorders, Circadian Rhythm, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye Mask-Based Blackout ProtocolOther
A non-pharmacological nursing intervention involving the use of an eye mask during nighttime sleep to reduce light exposure and support circadian rhythm regulation in intensive care unit patients.
| Study group | Role | What they receive |
|---|---|---|
| Eye Mask Intervention Group | Experimental | Participants received a nighttime eye mask-based blackout protocol during sleep hours in the intensive care unit in addition to routine care. Receives: Other: Eye Mask-Based Blackout Protocol |
| Control Group | No intervention | Participants received routine intensive care without the use of an eye mask. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep quality (Richard-Campbell Sleep Questionnaire [RCSQ] total score)
Change in sleep quality assessed using the Richard-Campbell Sleep Questionnaire (6 items, 0-100 VAS each; higher scores indicate better sleep). The total score is calculated as the mean of all item scores.
Measured: Measured twice: (1) baseline-morning of ICU day 2 (after the first night, 23:00-05:00), and (2) post-intervention-morning of ICU day 3 (after the blackout night with eye mask from 23:00 to 05:00).
Secondary outcomes (2)
Sleep quality (Visual Analogue Scale [VAS], 1-10)
Self-reported sleep quality rated on a 1-10 scale (1 = worst sleep quality, 10 = best sleep quality).
Measured: Measured twice: (1) baseline-morning of ICU day 2 (after the first night, 23:00-05:00), and (2) post-intervention-morning of ICU day 3 (after the blackout night with eye mask from 23:00 to 05:00).
Urinary 6-sulfatoxymelatonin (aMT6s) level (ng/mg creatinine)
Change in melatonin secretion assessed by urinary 6-sulfatoxymelatonin (aMT6s) measured by ELISA and normalized to urinary creatinine (ng/mg creatinine). Urine was collected via Foley catheter drainage.
Measured: Measured twice using overnight urine collection: (1) baseline-urine accumulated from 23:00 to 05:00 on the first night (ICU day 2 morning sample), and (2) post-intervention-urine accumulated from 23:00 to 05:00 on the blackout night with eye mask (ICU da
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start1 Aug 2024
- Primary completion1 May 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to either an intervention group or a control group and followed in parallel throughout the study period.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahar Ciftci, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07385768
- Sponsor's protocol ID
- ATAUNI-SLEEP-ICU-01
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akpinar RB, Koc G, Kutlu Z, Ciftci B, Elis T. The effect of an eye mask-based blackout protocol on patients' sleep quality and melatonin levels: a randomised controlled trial. BMC Nurs. 2026 Jul 30;25(1):1024. doi: 10.1186/s12912-026-04995-0.
PubMed 42934636
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Eye Mask-Based Blackout Protocol on Patients' Sleep Quality and Melatonin Levels: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07385768
- Acronym / sponsor ID
- ATAUNI-SLEEP-ICU-01
- Keywords
- Eye mask, Light exposure, Melatonin, Sleep quality, Intensive care unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 4 Feb 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 disturbance is a common problem among patients hospitalized in intensive care units due to continuous light exposure, noise, and frequent medical interventions. Disruption of the normal day-night cycle may reduce melatonin secretion and negatively affect sleep quality and recovery.
This randomized controlled study aimed to evaluate the effect of an eye mask-based blackout protocol on sleep quality and melatonin levels in patients hospitalized in a chest intensive care unit. Participants were randomly assigned to either an intervention group or a control group. Patients in the intervention group wore a lightproof eye mask during nighttime hours (11:00 p.m. to 05:00 a.m.) in addition to standard light-reduction practices, while the control group received routine intensive care.
Sleep quality was assessed using validated subjective scales, and melatonin levels were evaluated by measuring urinary 6-sulfatoxymelatonin. The study sought to determine whether reducing nighttime light exposure using a simple, non-invasive intervention could improve sleep quality and support circadian rhythm regulation in intensive care patients.
Detailed description
This study was designed as a randomized controlled trial to investigate the effect of an eye mask-based blackout protocol on sleep quality and melatonin levels in patients hospitalized in a chest intensive care unit.
The study was conducted at a university research hospital in Turkey. Eligible adult patients who were conscious, breathing spontaneously, and able to provide informed consent were randomly assigned to either an intervention group or a control group using a 1:1 allocation ratio. Patients receiving mechanical ventilation or using medications affecting melatonin secretion were excluded.
Participants in the intervention group wore a lightproof eye mask between 11:00 p.m. and 05:00 a.m. for two consecutive nights. In addition to eye mask use, nighttime lighting in the patient's room was minimized according to a standardized protocol. The control group received routine intensive care without any additional light-reduction intervention.
Sleep quality was evaluated using the Visual Analogue Scale for Sleep Quality and the Richard Campbell Sleep Scale. Melatonin secretion was assessed by measuring urinary 6-sulfatoxymelatonin levels collected overnight. Urine samples were stored under controlled conditions and analyzed using an enzyme-linked immunosorbent assay (ELISA).
The primary objective of the study was to determine whether the eye mask-based blackout protocol improved subjective sleep quality. A secondary objective was to assess changes in melatonin levels as a biological marker of circadian rhythm regulation.
All procedures were conducted in accordance with the Declaration of Helsinki. Ethical approval was obtained from the relevant institutional ethics committee, and written informed consent was obtained from all participants prior to enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to either an intervention group or a control group and followed in parallel throughout the study period.
| Arm | Type | Receives |
|---|---|---|
| Eye Mask Intervention Group | Experimental | Other: Eye Mask-Based Blackout ProtocolParticipants received a nighttime eye mask-based blackout protocol during sleep hours in the intensive care unit in addition to routine care. |
| Control Group | No intervention | –Participants received routine intensive care without the use of an eye mask. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients aged 18 years and older
- Patients admitted to the intensive care unit
- Patients expected to remain in the intensive care unit for at least 24 hours
- Patients with the ability to tolerate an eye mask during nighttime sleep
- Patients or their legal representatives who provided informed consent
Key exclusion criteria (5 listed)
- Patients with facial trauma, eye injury, or ophthalmologic conditions preventing eye mask use
- Patients receiving continuous deep sedation
- Patients with severe cognitive impairment or delirium preventing cooperation
- Patients with diagnosed sleep disorders prior to intensive care admission
- Patients who refused to participate in the study
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 Mask-Based Blackout ProtocolA non-pharmacological nursing intervention involving the use of an eye mask during nighttime sleep to reduce light exposure and support circadian rhythm regulation in intensive care unit patients. | Other | Eye Mask Intervention Group |
Primary outcome
Sleep quality (Richard-Campbell Sleep Questionnaire [RCSQ] total score)
Time frame: Measured twice: (1) baseline-morning of ICU day 2 (after the first night, 23:00-05:00), and (2) post-intervention-morning of ICU day 3 (after the blackout night with eye mask from 23:00 to 05:00).
Change in sleep quality assessed using the Richard-Campbell Sleep Questionnaire (6 items, 0-100 VAS each; higher scores indicate better sleep). The total score is calculated as the mean of all item scores.
2 secondary outcomes
Sleep quality (Visual Analogue Scale [VAS], 1-10)
Time frame: Measured twice: (1) baseline-morning of ICU day 2 (after the first night, 23:00-05:00), and (2) post-intervention-morning of ICU day 3 (after the blackout night with eye mask from 23:00 to 05:00).
Urinary 6-sulfatoxymelatonin (aMT6s) level (ng/mg creatinine)
Time frame: Measured twice using overnight urine collection: (1) baseline-urine accumulated from 23:00 to 05:00 on the first night (ICU day 2 morning sample), and (2) post-intervention-urine accumulated from 23:00 to 05:00 on the blackout night with eye mask (ICU da
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 4 Feb 2026.
- Derived from this study: PubMed 42934636Akpinar RB, Koc G, Kutlu Z, Ciftci B, Elis T. The effect of an eye mask-based blackout protocol on patients' sleep quality and melatonin levels: a randomised controlled trial. BMC Nurs. 2026 Jul 30;25(1):1024. doi: 10.1186/s12912-026-04995-0.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Mask-Based Blackout Protocol in people with Sleep Disturbance and Circadian Rhythm Sleep Disorders, run by Ataturk 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 5 inclusion and 5 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 4 Feb 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 (Richard-Campbell Sleep Questionnaire [RCSQ] total score) (time frame: Measured twice: (1) baseline-morning of ICU day 2 (after the first night, 23:00-05:00), and (2) post-intervention-morning of ICU day 3 (after the blackout night with eye mask from 23:00 to 05:00).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07385768, which also lists 1 linked publication.
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 4 Feb 2026.