Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000313538p
Ethics application status
Submitted, not yet approved
Date submitted
31/01/2024
Date registered
22/03/2024
Date last updated
22/03/2024
Date data sharing statement initially provided
22/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Brain stimulation to target slow brain waves and cognition in obstructive sleep apnea
Scientific title
Slow oscillation transcranial direct current stimulation in adults with obstructive sleep apnea: a proof-of-concept study
Secondary ID [1] 311394 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obstructive sleep apnea 332667 0
Condition category
Condition code
Respiratory 329372 329372 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Proof of concept/ Feasibility study.
We aim to compare if two configurations (frontal vs parietal vs sham) of slow oscillation-transcranial direct current stimulation are effective at boosting sleep markers in middle to late age people with obstructive sleep apnea. We will recruit 5 participants for this proof of concept, feasibility study. Participants will complete 3 daytime nap studies at the Woolcock Institute, with at least 1 week washout between sessions. At the visits they will complete a memory and a cognition task before and after a 90-minute nap with each condition of slow-oscillation transcranial direct current stimulation (so-tDCS) applied at each visit (2 active stimulation montages and sham). Participants will be fitted with a high-density electroencephalography (EEG) net with the stimulation electrodes nested between the cap. Stimulation will be applied using the Soterix M×N 33/65 High Definition-transcranial Electrical Stimulator using sintered HD electrodes. Active stimulation will consist of an anodal current sinusoidally oscillating at a frequency of 0.75 Hz between zero and 260 µA. The maximum current density will be 0.522 mA/cm2. Channel impedance will be <2 kO. The low level so-tDCS stimulation will be applied in 5 x 5-minute stimulation blocks by trained researchers. Following each nap participants will complete a perceived effects and tolerability questionnaire which probes blinding, tolerability and acceptability of the intervention. Researchers will also monitor recruitment statistics and data completion throughout the study.
Intervention code [1] 327832 0
Treatment: Devices
Comparator / control treatment
The sham condition will be identical to the stimulation conditions however the stimulation intensity will not be high enough to generate meaningful cortical excitability (>0.1mA).
Control group
Active

Outcomes
Primary outcome [1] 337193 0
Global slow oscillation densities (slow oscillation power 0.5-1Hz and delta/slow wave activity 1-4.5Hz) averaged across measurement blocks.
Timepoint [1] 337193 0
The primary outcome will be assessed across 3 study visits. Electroencephalography will be measured in NREM (N2 and N3 slee0) for 60 seconds after each stimulation block for 5 blocks.
Primary outcome [2] 337410 0
Regional slow oscillation densities (slow oscillation power 0.5-1Hz and delta/slow wave activity 1-4.5Hz) averaged across measurement blocks.
Timepoint [2] 337410 0
The primary outcome will be assessed across 3 study visits. Electroencephalography will be measured in NREM (N2 and N3 slee0) for 60 seconds after each stimulation block for 5 blocks.
Secondary outcome [1] 431012 0
Recruitment statistics will be assessed across 3 study visits.
Timepoint [1] 431012 0
Recruitment success will be assessed for all participants contacted for screening.
Secondary outcome [2] 431013 0
Data completion
Timepoint [2] 431013 0
Data completion outcome will be assessed at the end of each visit and calculated at the end of the study.
Secondary outcome [3] 431014 0
Blinding success
Timepoint [3] 431014 0
Blinding outcome will be assessed once at the end of each visit.
Secondary outcome [4] 431199 0
Acceptability of intervention (Descriptive composite of perceived effectiveness, burden rating, willingness to participate)
Timepoint [4] 431199 0
The acceptability of intervention outcome will be collected once at the end of each visit.
Secondary outcome [5] 431768 0
Tolerability
Timepoint [5] 431768 0
Tolerability will be collected once at the end of each visit.

Eligibility
Key inclusion criteria
Moderate to severe OSA (polysomnography (PSG) within 1 year with AHI equal to 15 or any night oximetry 3% ODI equal to 15), are fluent in English, are able to perform cognitive tasks are willing to provide informed consent and willingness to participate and comply with the study requirements.
Minimum age
40 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they;
• Have a history of head injury with associated loss of consciousness equal to or greater than 30 minutes;
• Have any current or previous diagnosis of psychiatric conditions (other than well managed affective disorders - beck depression inventory 2 score equal to 19 and no current feelings of suicidality as determined by item 9, beck anxiety inventory score equal to 15 severity);
• Have any diagnosis of a neurological disorder (e.g. Parkinson’s disease, epilepsy, multiple sclerosis);
• Have a diagnosis of cognitive impairment or dementia or a Mini-Mental State Examination Score less than 24
• Have a history of cerebrovascular events (e.g. stroke, TIA);
• Have any clinically significant comorbidity which will impede participation (as decided by the study doctor);
• Currently regularly use central nervous system active agents (e.g. cholinergic, anticonvulsant);
• Have a history of substance abuse or heavy alcohol use (greater than 10 standard drinks a week and greater than 4 standard drinks on any one day.);
• Are a current shift-worker or travel overseas within the last 2 weeks;
• Have previously used treatment for obstructive sleep apnea (e.g. CPAP) in the last 2 months;
• Are currently pregnant;
• Have a history of migraine;
• Have metallic implants including intracranial electrodes, surgical clips, shrapnel or a pacemaker;
• Have history of seizure;
• Have had adverse effects to previous brain stimulation methods;
• Previous adverse reaction to topical anaesthetic;
• Have a diagnosis of another primary sleep disorder (determined via medical screening or Insomnia Severity Index score equal to 12);
• Are unable to easily nap in the afternoon (determined by questionnaire).

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Linear mixed effects model will be performed to compare global and regional frequencies across conditions. The conditions will be assigned as a fixed factor and participant ID will be assigned as a random factor (i.e. random intercept).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/04/2024
Actual
Date of last participant enrolment
Anticipated
1/08/2024
Actual
Date of last data collection
Anticipated
31/08/2024
Actual
Sample size
Target
5
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 26077 0
Woolcock Institute of Medical Research - Glebe
Recruitment postcode(s) [1] 41932 0
2037 - Glebe

Funding & Sponsors
Funding source category [1] 315653 0
Charities/Societies/Foundations
Name [1] 315653 0
Centre for Chronic Diseases of Ageing
Country [1] 315653 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Woolcock Institute of Medical Research
Address
1 Innovation RdMacquarie Park NSW 2113
Country
Australia
Secondary sponsor category [1] 317977 0
None
Name [1] 317977 0
none
Address [1] 317977 0
Country [1] 317977 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314537 0
Sydney Local Health District Ethics Review Committee RPAH
Ethics committee address [1] 314537 0
Level 11, King George V Building, Missenden Road, Camperdown NSW 2050
Ethics committee country [1] 314537 0
Australia
Date submitted for ethics approval [1] 314537 0
29/01/2024
Approval date [1] 314537 0
Ethics approval number [1] 314537 0

Summary
Brief summary
People with obstructive sleep apnea show impairments in cognition and are at risk for developing dementia. Slow wave brain waves, occuring during “deep sleep”, have been associated with cognition are less prominent in people with sleep apnea. This research study aims to understand whether low current brain stimulation applied on different areas can boost slow brain waves during sleep in people with obstructive sleep apnea. This study involves 3 in-person daytime visits to the Woolcock Institute of Medical Research where participants will undergo cognitive testing before and after a nap with low intensity brain stimulation applied during sleep.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131934 0
Dr Angela D'Rozario
Address 131934 0
Dr. Angela D'Rozario, Woolcock Institute of Medical Research, 2 Innovation rd, Macquarie Park NSW 2113
Country 131934 0
Australia
Phone 131934 0
+610298053289
Fax 131934 0
Email 131934 0
angela.drozario@mq.edu.au
Contact person for public queries
Name 131935 0
Dr Andrea Ricciardiello
Address 131935 0
Dr. Angela D'Rozario, Woolcock Institute of Medical Research, 2 Innovation rd, Macquarie Park NSW 2113
Country 131935 0
Australia
Phone 131935 0
+610298053289
Fax 131935 0
Email 131935 0
andrea.ricciardiello@woolcock.org.au
Contact person for scientific queries
Name 131936 0
Dr Andrea Ricciardiello
Address 131936 0
Dr. Angela D'Rozario, Woolcock Institute of Medical Research, 2 Innovation rd, Macquarie Park NSW 2113
Country 131936 0
Australia
Phone 131936 0
+610298053289
Fax 131936 0
Email 131936 0
andrea.ricciardiello@woolcock.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Only de-identified processed data will be shared.


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.