The Effect of Pink Noise and the Quiet Night Intervention on Sleep Parameters in Intensive Care Unit Patients: A Single-Center Randomized Controlled Trial
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
1 other identifier
interventional
18
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2026
CompletedFirst Posted
Study publicly available on registry
February 17, 2026
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
April 22, 2026
April 1, 2026
8 months
February 4, 2026
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sleep Efficiency
Sleep efficiency will be measured using a single wrist-worn actigraphy device (smartwatch) during nighttime sleep (23:00-06:00).
Single night (23:00-06:00)
Secondary Outcomes (4)
Total Sleep Time
Single night (23:00-06:00)
Sleep Onset Latency
Single night (23:00-06:00)
Wake After Sleep Onset
Single night (23:00-06:00)
Number of Nocturnal Awakenings
Single night (23:00-06:00)
Study Arms (3)
Acoustic Noise Masking Group
EXPERIMENTALPatients receiving environmental acoustic noise masking before and during nighttime sleep.
Quiet Night Intervention Group
ACTIVE COMPARATORPatients receiving a quiet night protocol including environmental noise and light reduction supported by earplugs and eye mask.
Standard Care Control Group
NO INTERVENTIONPatients receiving routine intensive care without additional sleep-promoting interventions.
Interventions
Environmental acoustic noise masking applied before and during nighttime sleep to reduce ambient ICU noise and support sleep continuity.
A quiet night protocol including environmental noise and light reduction supported by earplugs and an eye mask.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bolu Izzet Baysal State Hospital
Bolu, Bolu, 14100, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Outcome assessors and data analysts are blinded to group allocation. Participants and care providers are not blinded due to the nature of the interventions.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 4, 2026
First Posted
February 17, 2026
Study Start
May 1, 2026
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Last Updated
April 22, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
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.