About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Acoustic Noise Masking Intervention
BehavioralEnvironmental acoustic noise masking applied before and during nighttime sleep to reduce ambient ICU noise and support sleep continuity.
Quiet Night Intervention
BehavioralA quiet night protocol including environmental noise and light reduction supported by earplugs and an eye mask.
Treatment groups
Trial outcomes
Primary outcomes
Sleep Efficiency
Sleep efficiency will be measured using a single wrist-worn actigraphy device (smartwatch) during nighttime sleep (23:00-06:00).
Secondary outcomes
Total Sleep Time
Total sleep time will be measured using the same single wrist-worn actigraphy device (smartwatch) during nighttime sleep.
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).
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).
Number of Nocturnal Awakenings
The number of nocturnal awakenings will be measured using the same single wrist-worn actigraphy device (smartwatch) during nighttime sleep.
Sponsors and contacts
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