Skip to content

Sleep Quality in Critical Care

Sleep Quality in Critical Care: Effect of overnight use of ear plugs on sleep quality in intensive care unit (ICU) patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624001307594
Enrollment
18
Registered
2024-10-28
Start date
2024-04-17
Completion date
2025-12-29
Last updated
2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of this study is to investigate whether the use of earplugs at night will improve our patients sleep and reduce the numbers of patients who develop delirium (a sudden change in your health condition that may include confused thinking or unsettled behaviour) while in ICU.

Interventions

Intervention arm: Use of ear plugs overnight by eligible ICU patients The intervention group will be supplied with foam earplugs (3M Classic foam earplug) to be used from 22:00 to 06:00 hours, for 2 nights. Participants will be asked to complete the Richards Campbell Sleep Questionnaire (RSCQ) on the morning of the 3rd day. Hours of ear plug use will be recorded, with ICU nurse to monitor for ear plugs being in situ during regular overnight observations Hours of sleep/wake will be recorded, with

Intervention arm: Use of ear plugs overnight by eligible ICU patients The intervention group will be supplied with foam earplugs (3M Classic foam earplug) to be used from 22:00 to 06:00 hours, for 2 nights. Participants will be asked to complete the Richards Campbell Sleep Questionnaire (RSCQ) on the morning of the 3rd day. Hours of ear plug use will be recorded, with ICU nurse to monitor for ear plugs being in situ during regular overnight observations Hours of sleep/wake will be recorded, with ICU nurse to monitor for sleep / wake during regular overnight observations Participants will be screened twice daily by ICU trained nurses using the validated Confusion Assessment Method (CAM). Staff conducting CAM assessments are not blinded. CAM assessment once per shift is standard care.

Sponsors

Dr Anas Naeem
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. adults aged 18 years and over; 2. expected length of stay in the ICU of more than 48 hours; 3. ability of patients to communicate verbally and understand the sleep questionnaire; and 4. able to provide informed consent.

Exclusion criteria

1. Mechanically ventilated and sedated patients; 2. pre-existing cognitive impairment in the medical record; 3. contraindications for use of ear plugs e.g acute brain injury as ICU admission diagnosis, use of hearing aids; and 4. prior enrolment.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026