Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001039471
Ethics application status
Approved
Date submitted
2/07/2025
Date registered
19/09/2025
Date last updated
19/09/2025
Date data sharing statement initially provided
19/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Sound Asleep: A Novel Approach to Treat Obstructive Sleep Apnoea and Associated Cognitive Impairment
Scientific title
Sound Asleep: Evaluating the Effect of Acoustic Stimulation on Slow Wave Activity and Cognition in patients with Obstructive Sleep Apnoea
Secondary ID [1] 314663 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnoea 337837 0
Condition category
Condition code
Respiratory 334170 334170 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will be a cross over trial, with a 7 day wash out period between the experimental condition and the control condition. It will be delivered in person and individually in a controlled sleep laboratory by sleep study technicians. Participants will undergo a two night in-laboratory stay at the Monash Sleep and Circadian Medicine Laboratory at the Be Active Sleep Eat (BASE) facility where they will use the Sleep Loop acoustic stimulation during their sleep for both nights. The Sleep Loop device will administer pulses of auditory tones via earphones that are precisely timed to the slow wave activity during stage 3 sleep, which help strengthen and increase its amplitude. The experimental condition (STIM) will utilise a windowed approach where stimulations will be enabled for an interval of 6 seconds (ON window) and immediately thereafter disabled for another 6 seconds (OFF window). To avoid waking participants due to the auditory stimuli, the volume of the stimuli will be adapted to the depth of sleep and stimulus related to detected arousal.
Intervention code [1] 331288 0
Treatment: Devices
Comparator / control treatment
Placebo (SHAM condition). During this condition, participants will wear the Sleep Loop device however tones will be inaudible, played at a volume of 0.
Control group
Placebo

Outcomes
Primary outcome [1] 341830 0
Slow Wave Activity (SWA) Enhancement Response
Timepoint [1] 341830 0
Experimental night 1 and 2 (STIM vs SHAM)
Secondary outcome [1] 448838 0
Sleepiness
Timepoint [1] 448838 0
Morning following experimental night 1 and 2 (STIM vs SHAM).
Secondary outcome [2] 448839 0
Device feasibility
Timepoint [2] 448839 0
Morning following experimental night 2
Secondary outcome [3] 449149 0
Sleep dependent declarative memory
Timepoint [3] 449149 0
Evening and following morning of the experimental night 1 and experimental night 2 (STIM vs SHAM)
Secondary outcome [4] 449910 0
OSA physiology
Timepoint [4] 449910 0
Experimental night 1 and following morning (STIM vs SHAM)
Secondary outcome [5] 449911 0
Emotional memory
Timepoint [5] 449911 0
Morning following experimental night 1 and 2 (STIM vs SHAM)
Secondary outcome [6] 451264 0
Processing speed
Timepoint [6] 451264 0
Morning following experimental night 1 and 2 (STIM vs SHAM)
Secondary outcome [7] 451265 0
Executive functioning
Timepoint [7] 451265 0
Morning following experimental night 1 and 2 (STIM vs SHAM)
Secondary outcome [8] 451266 0
Working memory
Timepoint [8] 451266 0
Morning following experimental night 1 and 2 (STIM vs SHAM)
Secondary outcome [9] 452270 0
OSA physiology
Timepoint [9] 452270 0
Experimental night 1 and following morning (STIM vs SHAM)
Secondary outcome [10] 452271 0
OSA physiology
Timepoint [10] 452271 0
Experimental night 1 and following morning (STIM vs SHAM)

Eligibility
Key inclusion criteria
Apnea-Hypopnea Index (AHI) >5 events/hr (determined by overnight sleep study)
Aged 35-50 years
Diagnosis of OSA with no prior treatment for at least 6 months
Fluent in English and able to provide informed consent.
Minimum age
35 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- No current or previous medical, neurological (e.g., traumatic brain injury, stroke) or severe psychiatric (e.g., psychosis) disorders that affect SWA enhancement and cognition, including medication affecting the central nervous system (e.g., beta blockers)
- A sleep disorder other than OSA
- Mild cognitive impairment (age and education adjusted cut-off on Mini Mental State Exam) or dementia diagnosis
- Regular night-shift worker
- Excessive daytime sleepiness (Epworth Sleepiness Scale score >16)
- Professional drivers
- Extreme hearing loss as the acoustic device upper limit is 76dB

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using random order generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
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
1/10/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
28
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 319226 0
Government body
Name [1] 319226 0
NHMRC
Country [1] 319226 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 321696 0
None
Name [1] 321696 0
Address [1] 321696 0
Country [1] 321696 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317805 0
Monash Health Human Research Ethics Committee B
Ethics committee address [1] 317805 0
Ethics committee country [1] 317805 0
Australia
Date submitted for ethics approval [1] 317805 0
23/07/2025
Approval date [1] 317805 0
11/09/2025
Ethics approval number [1] 317805 0

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

Contacts
Principal investigator
Name 142214 0
A/Prof Melinda Jackson
Address 142214 0
18 Innovation Walk, Clayton VIC 3800, Monash University
Country 142214 0
Australia
Phone 142214 0
+61 0399050206
Fax 142214 0
Email 142214 0
[email protected]
Contact person for public queries
Name 142215 0
Melinda Jackson
Address 142215 0
18 Innovation Walk, Clayton VIC 3800, Monash Univeristy
Country 142215 0
Australia
Phone 142215 0
+61 0399050206
Fax 142215 0
Email 142215 0
[email protected]
Contact person for scientific queries
Name 142216 0
Melinda Jackson
Address 142216 0
18 Innovation Walk, Clayton VIC 3800, Monash University
Country 142216 0
Australia
Phone 142216 0
+61 0399050206
Fax 142216 0
Email 142216 0
[email protected]

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


What supporting documents are/will be available?

No Supporting Document Provided


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.