The Effect of Pink Noise and the Quiet Night Intervention on Sleep Parameters in Intensive Care U… (NCT07412964) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Effect of Pink Noise and the Quiet Night Intervention on Sleep Parameters in Intensive Care Unit Patients: A Single-Center Randomized Controlled Trial
Turkey (Türkiye)18 participantsStarted 2026-05
Plain-language 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.
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Inclusion Criteria:
* 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
Exclusion Criteria:
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.