Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001292369
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
7/10/2026
Date registered
Help: Date registered
28/10/2026
Date last updated
Help: Date last updated
28/10/2026
Date data sharing statement initially provided
Help: Data sharing statement date
28/10/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
WHISPER-ICU: A study evaluating the effect of white noise on total sleep time in non-ventilated patients in the Intensive Care Unit
Scientific title
WHISPER-ICU: A randomised controlled cross over study evaluating the effect of white noise on total sleep time in non-ventilated patients in the Intensive Care Unit
Additional trial identifiers [1] 318590 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Sleep disturbance 343794 0
Condition category
Condition code
Neurological 339928 339928 0 0
Other neurological disorders
Public Health 340013 340013 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
White noise delivered by a dedicated white noise machine during the hours of 2200 and 0600 at the bedside of non-ventilated patients in the intensive care unit.
The white noise intervention will be delivered to participants by a sound machine, positioned in a standardised location near the head of the participant’s bed and controlled by the bedside nurse and/or patient at set times. When allocated to the white noise intervention, participants will be able to select from one of 30 non-looping nature sounds, which will play from 2200-0600h. The sound machine also has an optional adaptive mode where the machine will automatically adjust the volume to mask out unwanted noises.
The sleep promotion bundle will be administered by the bedside nurse and includes lighting adjustments, noise reduction, temperature control, comfort and positioning, cluster care activities, and pain management considerations. The sleep bundle will be administered at the same time as the intervention.
The intervention will be randomised to night 1 or night 2 after consent to participate in the trial.

Night 1 and night 2 are consecutive nights (i.e. there is no washout period), The decision for no washout has been made as white noise has no pharmacological half-life, the direct auditory masking effect ceases when the intervention stops, and sleep quality is assessed separately each night. A washout night would also increase the study duration and potentially reduce feasibility in ICU patients.

Intervention code [1] 335499 0
Treatment: Devices
Description of the comparator or control
Standard environmental exposure without a dedicate white noise machine
Control group
Active

Outcomes
Primary outcome [1] 347095 0
The effect of white noise on total sleep time in non-ventilated ICU patients
Timepoint [1] 347095 0
22:00-06:00 Night 1 22:00-06:00 Night 2 Patients will be randomised to white noise or standard care on night 1, and recieve the alternative treatment on night 2.
Secondary outcome [1] 468912 0
Measures of Sleep Quality including wake after sleep onset, sleep latency, sleep depth, ability to return to sleep, and subjective noise rating. This is a composite score between 0 and 100
Timepoint [1] 468912 0
Within 24hrs of completion of study, that includes exposure to both the intervention and standard of care on subsequent nights.
Secondary outcome [2] 468913 0
Sleep Fragmentation
Timepoint [2] 468913 0
Assessed from 22:00-0:600 on subsequent nights
Secondary outcome [3] 468914 0
Sleep efficiency
Timepoint [3] 468914 0
From 22:00 to 0:600 on subsequent nights, randomised to intervention on night one or night two
Secondary outcome [4] 469305 0
Sleep latency
Timepoint [4] 469305 0
At end of each study period (22:00 to 0:600)
Secondary outcome [5] 469306 0
Wake after sleep onset
Timepoint [5] 469306 0
At end of each study period (22:00 to 0:600)

Eligibility
Key inclusion criteria
The study will be conducted in critically ill adult patients (18 years or older) admitted to a tertiary hospital ICU, who are not receiving invasive mechanical ventilation at the time of sleep monitoring. Participants will include both medical and surgical ICU patients with a range of acute conditions including sepsis, trauma, neurological, and respiratory disease not requiring invasive ventilation, as well as participants admitted to ICU post-surgery for monitoring.

Other key inclusion criteria include: predicted admission to ICU for over 48 hours, ability to communicate in writing, and an absence of a hearing impairment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
• Age <18 years
• Ventilated patients (invasive or non-invasive)
• Predicted admission to ICU for <48 hours
• Richmond Agitation and Sedation Scale (RASS) 2 or -2
• Continuous sedative infusions
• Pre-existing sleep disorders e.g. severe Obstructive Sleep Apnoea (Apnoea-Hypopnoea Index 30/hour), narcolepsy
• Patients admitted for palliation or end of life
• Agitated delirium
• Inability to provide informed consent or absence of Person Responsible
• Unable to read or independently complete the Richards-Campbell Sleep Questionnaire due to significant visual impairment
• Not fluent in English, where a professional interpreter is not available to support the consent discussion
• Contraindication to the wrist-worn actigraphy device:
• Skin integrity at device site (burns, open wounds, skin infection)
• Limb injury (casts, dressings) or immobilisation preventing device application
• Medical equipment (intravenous or arterial line)
• Severe agitated delirium
• Unable to fit to wrist due to body habitus or underlying disease (e.g. oedema)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomised using a computer-generated random allocation sequence created within RedCap's randomisation module, using block randomisation (block size of 4, randomly varied) to achieve 1:1 allocation to a white-noise-first or control-first sequence. The allocation sequence will be concealed until enrolment is confirmed and the participant's details entered into RedCap, at which point the next allocation is revealed. Sleep scientists (and nurses) undertaking ACTG outcome assessment will remain blinded to treatment allocation; given the audible nature of the intervention, participants and ICU clinicians cannot be blinded
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random sequence using block randomisation (block size of 4, randomly varied) to achieve 1:1 allocation to a white-noise-first or control-first sequence.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/11/2026
Actual
Date of last participant enrolment
Anticipated
2/11/2027
Actual
Date of last data collection
Anticipated
15/11/2027
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 30326 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 46739 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 323166 0
Hospital
Name [1] 323166 0
Gold Coast University Hospital, Gold Coast Health
Country [1] 323166 0
Australia
Primary sponsor type
Individual
Name
Kerina Denny - Gold Coast University Hospital
Address
Country
Australia
Secondary sponsor category [1] 326128 0
Individual
Name [1] 326128 0
Tess Kelly - Gold Coast University Hospital
Address [1] 326128 0
Country [1] 326128 0
Australia
Secondary sponsor category [2] 326130 0
Individual
Name [2] 326130 0
Sebastian Winn - Gold Coast University Hospital
Address [2] 326130 0
Country [2] 326130 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321571 0
Gold Coast Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 321571 0
Ethics committee country [1] 321571 0
Australia
Date submitted for ethics approval [1] 321571 0
Approval date [1] 321571 0
23/09/2026
Ethics approval number [1] 321571 0
HREC/2026/QGC/12846

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 154114 0
Dr Sebastian Winn
Address 154114 0
Intensive Care Unit, Gold Coast University Hospital, 1 Hospital Blvd, Southport, 4215, QLD
Country 154114 0
Australia
Phone 154114 0
+61 423 444 091
Fax 154114 0
Email 154114 0
[email protected]
Contact person for public queries
Name 154115 0
Kerina Denny
Address 154115 0
Intensive Care Unit, Gold Coast University Hospital, 1 Hospital Blvd, Southport, 4215, QLD
Country 154115 0
Australia
Phone 154115 0
+61 401 580 591
Fax 154115 0
Email 154115 0
[email protected]
Contact person for scientific queries
Name 154116 0
Kerina Denny
Address 154116 0
Intensive Care Unit, Gold Coast University Hospital, 1 Hospital Blvd, Southport, 4215, QLD
Country 154116 0
Australia
Phone 154116 0
+61 401 580 591
Fax 154116 0
Email 154116 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol    WHISPER-ICU_Protocol_V5_Clean.docx
Ethical approval    20260928_GCHHS_Authorisation_128466 (1).pdf
Informed consent form    PICF for WHISPER-ICU.docx


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.