The Effect of Pink Noise and the Quiet Night Intervention on Sleep Parameters in Intensive Care Unit Patients: A Single-Center Randomized Controlled Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbant Izzet Baysal University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Acoustic Noise Masking Intervention

    Behavioral

    Environmental acoustic noise masking applied before and during nighttime sleep to reduce ambient ICU noise and support sleep continuity.

  • Quiet Night Intervention

    Behavioral

    A quiet night protocol including environmental noise and light reduction supported by earplugs and an eye mask.

Treatment groups

18 Participants
are divided into 3 treatment groups
Group A: Acoustic Noise Masking GroupExperimental treatment 1 intervention
Group B: Quiet Night Intervention GroupActive comparator 1 intervention
Group C: Standard Care Control GroupNo intervention 0 interventions

Trial outcomes

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).

Time frame
Single night (23:00-06:00)

Secondary outcomes

1

Total Sleep Time

Total sleep time will be measured using the same single wrist-worn actigraphy device (smartwatch) during nighttime sleep.

Time frame
Single night (23:00-06:00)
2

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).

Time frame
Single night (23:00-06:00)
3

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).

Time frame
Single night (23:00-06:00)
4

Number of Nocturnal Awakenings

The number of nocturnal awakenings will be measured using the same single wrist-worn actigraphy device (smartwatch) during nighttime sleep.

Time frame
Single night (23:00-06:00)

Other outcomes

Sponsors and contacts

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