Sleep DisturbanceNCT07412964
The Effect of Pink Noise and the Quiet Night Intervention on Sleep Parameters in Intensive Care Unit Patients: A Single-Center Randomized Controlled Trial
A study testing Acoustic Noise Masking Intervention and Quiet Night Intervention in people with Sleep Disturbance and Intensive Care Units, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
Sleep disruption is common in adult intensive care unit (ICU) patients and is often worsened by environmental noise and nighttime care activities. Poor sleep may negatively affect recovery and well-being. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disturbance, Intensive Care Units
- What is being tested?
- Acoustic Noise Masking Intervention and Quiet Night Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2026to 20 Sep 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years and older
- Patients admitted to the adult intensive care unit
- Expected ICU stay of at least one night
- Ability to tolerate non-invasive sleep-related interventions (earplugs, eye mask, or acoustic masking)
- Informed consent obtained from the patient or legally authorized representative
Who cannot join
- Severe hearing impairment preventing use of acoustic interventions
- Severe cognitive impairment or coma preventing sleep assessment
- Use of continuous deep sedation
- Diagnosed sleep disorders requiring pharmacological treatment
- Skin conditions preventing use of wrist-worn actigraphy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu Izzet Baysal State Hospital
Bolu, Bolu, 14100
About this study
Official title: The Effect of Pink-Brown Noise and the Quiet Time Intervention on Sleep Parameters in Intensive Care Unit Patients: A Single-Center, Randomized Controlled Trial
Sleep disruption is common in adult intensive care unit (ICU) patients and is often worsened by environmental noise and nighttime care activities. Poor sleep may negatively affect recovery and well-being.
This single-center, three-arm randomized controlled trial will evaluate the short-term effects of two non-pharmacological interventions-(1) pink-brown noise masking and (2) a quiet time intervention-on objective sleep parameters in adult ICU patients, compared with standard care.
Sleep outcomes will be measured using actigraphy-based wearable monitoring, including total sleep time, sleep efficiency, sleep onset latency, wake after sleep onset, and number of awakenings. Results are expected to support evidence-based nursing approaches to improve sleep in ICU patients.
Read the detailed description
This study is designed as a single-center, three-arm, parallel-group randomized controlled clinical trial to evaluate the short-term effects of environmental acoustic masking and a quiet night intervention on objective sleep parameters in adult intensive care unit (ICU) patients.
Sleep disturbance is highly prevalent among critically ill patients due to environmental factors such as excessive noise, continuous light exposure, frequent nursing interventions, alarm sounds, mechanical ventilation, pain, anxiety, and disease-related physiological stress. These factors lead to fragmented and superficial sleep, disruption of the sleep-wake cycle, and are associated with adverse clinical outcomes including delirium, immune dysfunction, hemodynamic instability, prolonged ICU stay, and increased morbidity.
The study includes three groups:
- an acoustic masking intervention group,
- a quiet night intervention group, and
- a standard care control group.
The acoustic masking group will receive low-frequency, nature-based sound exposure prior to sleep onset, followed by earplug use throughout the night. The quiet night group will receive environmental noise and light reduction measures supported by earplugs and an eye mask. The control group will receive standard ICU care without additional sleep-promoting interventions.
Objective sleep parameters will be measured using wrist-worn actigraphy over a single night (23:00-06:00). Primary sleep outcomes include total sleep time, sleep efficiency, sleep onset latency, wake after sleep onset, and number of nocturnal awakenings. Actigraphy is selected as a feasible, non-invasive, and validated method for sleep assessment in critically ill populations.
Prior to the main trial, a pilot phase will be conducted to assess the feasibility of the study procedures, the applicability of the interventions, the functionality of data collection methods, and the variability of outcome measures required for sample size estimation. The pilot phase will include all three study arms and will follow the same methodology, eligibility criteria, intervention protocols, and outcome assessments as the main trial. Participants enrolled in the pilot phase will constitute an independent sample and will not be included in the final analysis of the main trial.
Data obtained from the pilot phase will be used solely for methodological refinement and sample size calculation. Findings from the pilot phase may be disseminated separately.
The study aims to generate evidence for low-cost, non-invasive, nurse-led environmental interventions that can be integrated into routine ICU care to improve sleep quality in critically ill patients.
- Conditions
- Sleep Disturbance, Intensive Care Units
- Being tested
- Acoustic Noise Masking Intervention, Quiet Night Intervention
- Keywords
- Intensive Care Units, Noise, Sound Masking, Actigraphy, Sleep Disturbance
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acoustic Noise Masking InterventionBehavioural
Environmental acoustic noise masking applied before and during nighttime sleep to reduce ambient ICU noise and support sleep continuity.
Quiet Night InterventionBehavioural
A quiet night protocol including environmental noise and light reduction supported by earplugs and an eye mask.
| Study group | Role | What they receive |
|---|---|---|
| Acoustic Noise Masking Group | Experimental | Patients receiving environmental acoustic noise masking before and during nighttime sleep. Receives: Behavioral: Acoustic Noise Masking Intervention |
| Quiet Night Intervention Group | Active comparator | Patients receiving a quiet night protocol including environmental noise and light reduction supported by earplugs and eye mask. Receives: Behavioral: Quiet Night Intervention |
| Standard Care Control Group | No intervention | Patients receiving routine intensive care without additional sleep-promoting interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Efficiency
Sleep efficiency will be measured using a single wrist-worn actigraphy device (smartwatch) during nighttime sleep (23:00-06:00).
Measured: Single night (23:00-06:00)
Secondary outcomes (4)
Total Sleep Time
Total sleep time will be measured using the same single wrist-worn actigraphy device (smartwatch) during nighttime sleep.
Measured: Single night (23:00-06:00)
Sleep Onset Latency
Sleep onset latency will be calculated as the time from lights-off to sleep onset using the same single wrist-worn actigraphy device (smartwatch).
Measured: Single night (23:00-06:00)
Wake After Sleep Onset
Wake after sleep onset will be measured as the total duration of wakefulness after sleep onset using the same single wrist-worn actigraphy device (smartwatch).
Measured: Single night (23:00-06:00)
Number of Nocturnal Awakenings
The number of nocturnal awakenings will be measured using the same single wrist-worn actigraphy device (smartwatch) during nighttime sleep.
Measured: Single night (23:00-06:00)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start30 Jun 2026
- Primary completion20 Sep 2026
- Study completion20 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-center, three-arm, parallel-group randomized controlled trial. Participants are randomly assigned to one of three groups: an acoustic noise-masking intervention group, a quiet night intervention group, or a standard care control group. Each participant receives only the assigned intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saadet Can Çiçek, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07412964
- Sponsor's protocol ID
- AIBU-SBF-NSS-2026
- Status last verified
- Oct 2026
- First submitted
- 4 Feb 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly. De-identified data may be made available upon reasonable request to the corresponding investigator, subject to ethical approval and institutional regulations.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pink-Brown Noise and the Quiet Time Intervention on Sleep Parameters in Intensive Care Unit Patients: A Single-Center, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07412964
- Acronym / sponsor ID
- AIBU-SBF-NSS-2026
- Conditions
- Sleep Disturbance, Intensive Care Units
- Keywords
- Intensive Care Units, Noise, Sound Masking, Actigraphy, Sleep Disturbance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- 20 Sep 2026 (actual)
- Study completion
- 20 Sep 2026 (actual)
- First posted
- 17 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 disruption is common in adult intensive care unit (ICU) patients and is often worsened by environmental noise and nighttime care activities. Poor sleep may negatively affect recovery and well-being.
This single-center, three-arm randomized controlled trial will evaluate the short-term effects of two non-pharmacological interventions-(1) pink-brown noise masking and (2) a quiet time intervention-on objective sleep parameters in adult ICU patients, compared with standard care.
Sleep outcomes will be measured using actigraphy-based wearable monitoring, including total sleep time, sleep efficiency, sleep onset latency, wake after sleep onset, and number of awakenings. Results are expected to support evidence-based nursing approaches to improve sleep in ICU patients.
Detailed description
This study is designed as a single-center, three-arm, parallel-group randomized controlled clinical trial to evaluate the short-term effects of environmental acoustic masking and a quiet night intervention on objective sleep parameters in adult intensive care unit (ICU) patients.
Sleep disturbance is highly prevalent among critically ill patients due to environmental factors such as excessive noise, continuous light exposure, frequent nursing interventions, alarm sounds, mechanical ventilation, pain, anxiety, and disease-related physiological stress. These factors lead to fragmented and superficial sleep, disruption of the sleep-wake cycle, and are associated with adverse clinical outcomes including delirium, immune dysfunction, hemodynamic instability, prolonged ICU stay, and increased morbidity.
The study includes three groups:
- an acoustic masking intervention group,
- a quiet night intervention group, and
- a standard care control group.
The acoustic masking group will receive low-frequency, nature-based sound exposure prior to sleep onset, followed by earplug use throughout the night. The quiet night group will receive environmental noise and light reduction measures supported by earplugs and an eye mask. The control group will receive standard ICU care without additional sleep-promoting interventions.
Objective sleep parameters will be measured using wrist-worn actigraphy over a single night (23:00-06:00). Primary sleep outcomes include total sleep time, sleep efficiency, sleep onset latency, wake after sleep onset, and number of nocturnal awakenings. Actigraphy is selected as a feasible, non-invasive, and validated method for sleep assessment in critically ill populations.
Prior to the main trial, a pilot phase will be conducted to assess the feasibility of the study procedures, the applicability of the interventions, the functionality of data collection methods, and the variability of outcome measures required for sample size estimation. The pilot phase will include all three study arms and will follow the same methodology, eligibility criteria, intervention protocols, and outcome assessments as the main trial. Participants enrolled in the pilot phase will constitute an independent sample and will not be included in the final analysis of the main trial.
Data obtained from the pilot phase will be used solely for methodological refinement and sample size calculation. Findings from the pilot phase may be disseminated separately.
The study aims to generate evidence for low-cost, non-invasive, nurse-led environmental interventions that can be integrated into routine ICU care to improve sleep quality in critically ill patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This is a single-center, three-arm, parallel-group randomized controlled trial. Participants are randomly assigned to one of three groups: an acoustic noise-masking intervention group, a quiet night intervention group, or a standard care control group. Each participant receives only the assigned intervention.
| Arm | Type | Receives |
|---|---|---|
| Acoustic Noise Masking Group | Experimental | Behavioral: Acoustic Noise Masking InterventionPatients receiving environmental acoustic noise masking before and during nighttime sleep. |
| Quiet Night Intervention Group | Active comparator | Behavioral: Quiet Night InterventionPatients receiving a quiet night protocol including environmental noise and light reduction supported by earplugs and eye mask. |
| Standard Care Control Group | No intervention | –Patients receiving routine intensive care without additional sleep-promoting interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 years and older
- Patients admitted to the adult intensive care unit
- Expected ICU stay of at least one night
- Ability to tolerate non-invasive sleep-related interventions (earplugs, eye mask, or acoustic masking)
- Informed consent obtained from the patient or legally authorized representative
Key exclusion criteria (5 listed)
- Severe hearing impairment preventing use of acoustic interventions
- Severe cognitive impairment or coma preventing sleep assessment
- Use of continuous deep sedation
- Diagnosed sleep disorders requiring pharmacological treatment
- Skin conditions preventing use of wrist-worn actigraphy
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 |
|---|---|---|
| Acoustic Noise Masking InterventionEnvironmental acoustic noise masking applied before and during nighttime sleep to reduce ambient ICU noise and support sleep continuity. | Behavioural | Acoustic Noise Masking Group |
| Quiet Night InterventionA quiet night protocol including environmental noise and light reduction supported by earplugs and an eye mask. | Behavioural | Quiet Night Intervention Group |
Primary outcome
Sleep Efficiency
Time frame: Single night (23:00-06:00)
Sleep efficiency will be measured using a single wrist-worn actigraphy device (smartwatch) during nighttime sleep (23:00-06:00).
4 secondary outcomes
Total Sleep Time
Time frame: Single night (23:00-06:00)
Sleep Onset Latency
Time frame: Single night (23:00-06:00)
Wake After Sleep Onset
Time frame: Single night (23:00-06:00)
Number of Nocturnal Awakenings
Time frame: Single night (23:00-06:00)
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 28 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly. De-identified data may be made available upon reasonable request to the corresponding investigator, subject to ethical approval and institutional regulations.
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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 Acoustic Noise Masking Intervention and Quiet Night Intervention in people with Sleep Disturbance and Intensive Care Units, run by Abant Izzet Baysal 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 28 Oct 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 Efficiency (time frame: Single night (23:00-06:00)). 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 28 Oct 2026.