Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000839505
Ethics application status
Approved
Date submitted
13/06/2024
Date registered
8/07/2024
Date last updated
4/08/2024
Date data sharing statement initially provided
8/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of neuromodulation on sleep and cognition in healthy older adults: A proof-of-concept study
Scientific title
The effects of neuromodulation on slow oscillations during sleep and cognition in healthy older adults: A proof-of-concept study
Secondary ID [1] 311723 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild cognitive impairment 333202 0
Alzheimer’s Disease 334309 0
Dementia 334310 0
Condition category
Condition code
Neurological 329889 329889 0 0
Neurodegenerative diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Proof-of-concept.
Participants will attend three randomised visits – 2 visits delivering active stimulation conditions (frontal or parietal) and 1 visit delivering the sham condition, with at least one week washout between visits. During the intervention, participants will wear a high-density electroencephalography (hdEEG) cap with the stimulation electrodes nested between the cap electrodes. The Soterix M×N 33 High Definition-transcranial Electrical Stimulator will be used for stimulation through the sintered HD electrodes. For the active stimulation condition, anodal current oscillating sinusoidally between 0 to 260µA at a frequency of 0.75Hz will be delivered to either the frontal lobe or parietal lobe region. The maximum current density will be 0.522 mA/cm2 and impedance will be <2KiloOhms. Stimulation will be delivered during a 90-min nap when participants reach stable NREM sleep (N2/N3). Stimulation will occur in five 5-minute blocks (overall 25 mins of stimulation) that are alternated by 100s stimulation-free blocks. Stimulation will be administered by a trained researcher at the sleep lab located in the Woolcock Institute of Medical Research. Participants will also complete a perceived effects and tolerability questionnaire pre- and post- nap to access blinding and perceived effects of the intervention. The researcher will be present in the sleep laboratory during the delivery of the intervention and will monitor and document intervention use and attendance for experimental visits will be documented on a checklist.
Intervention code [1] 328186 0
Treatment: Devices
Comparator / control treatment
The sham condition will be identical to the stimulation conditions however the stimulation intensity will be <0.1mA which will not be high enough to generate cortical excitability.
Control group
Placebo

Outcomes
Primary outcome [1] 337656 0
Technical feasibility. This will be assessed as a composite outcome.
Timepoint [1] 337656 0
Technical feasibility will be measured at each visit and calculated at the end of the study.
Secondary outcome [1] 436096 0
Acceptability
Timepoint [1] 436096 0
Acceptability will be measured at the end of the study.
Secondary outcome [2] 436822 0
Blinding
Timepoint [2] 436822 0
Blinding will be measured at the end of the study.
Secondary outcome [3] 436823 0
Perceived effects
Timepoint [3] 436823 0
Perceived effects will be measured at the end of each visit and at the end of the study.
Secondary outcome [4] 436824 0
Delta EEG power
Timepoint [4] 436824 0
Delta EEG power will be measured after each stimulation block.
Secondary outcome [5] 436825 0
Visuo-spatial recognition accuracy - Tertiary outcome
Timepoint [5] 436825 0
Visuo-spatial recognition accuracy will be measured 30 minutes before and after the nap at every visit.
Secondary outcome [6] 436826 0
Vigilance - Tertiary outcome
Timepoint [6] 436826 0
Vigilance will be measured 30 mins before and after the 90-min nap with brain stimulation at every visit.
Secondary outcome [7] 436827 0
Sigma EEG power - Tertiary outcome
Timepoint [7] 436827 0
Sigma EEG power will be measured after each stimulation block at every visit.
Secondary outcome [8] 436828 0
Slow oscillation events - Tertiary outcome
Timepoint [8] 436828 0
Slow oscillation events will be measured in NREM (N2 and N3) sleep after each stimulation block at every visit.
Secondary outcome [9] 436829 0
Sleep spindle events - Tertiary outcome
Timepoint [9] 436829 0
Sleep spindle events will be measured in NREM (N2 and N3) sleep after each stimulation block at every visit.
Secondary outcome [10] 436830 0
Slow oscillation and sleep spindle coupling events - Tertiary outcome
Timepoint [10] 436830 0
Slow oscillation and sleep spindle coupling events will be measured in NREM (N2 and N3) sleep after each stimulation block at every visit.
Secondary outcome [11] 436831 0
Sleep macro-architecture - Tertiary outcome
Timepoint [11] 436831 0
Sleep macro-architecture will be measured during the nap at every visit.
Secondary outcome [12] 436832 0
Actigraphy - Tertiary outcome
Timepoint [12] 436832 0
Actigraphy will be measured for 1 week prior to each of the 3 visits for 3 weeks in total.

Eligibility
Key inclusion criteria
Participants are fluent in English, able to perform cognitive tasks, willing to provide informed consent, and willing 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?
Yes
Key exclusion criteria
• Have a history of head injury with associated loss of consciousness >30 minutes;
• Have any current or previous diagnosis of psychiatric conditions (other than well managed
affective disorders - beck depression inventory 2 score less than or equal to 19 and no current feelings of suicidality as determined by item 9, beck anxiety inventory score less than or equal to 15 severity);
• Have any diagnosis of 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 <24;
• Have a history of cerebrovascular events (e.g. stroke, transient ischemic attack (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 (<10 standard drinks a week and <4
standard drinks on any one day);
• Are a current shift-worker or have travelled overseas within the last 2 weeks;
• Are currently pregnant;
• Have a history of migraine;
• Have metallic implants including intracranial electrodes, surgical clips, shrapnel or a pacemaker;
• Have a history of seizure;
• Have had adverse effects to previous brain stimulation methods;
• Previous adverse reaction to topical anaesthetic;
• Have a primary sleep disorder (Insomnia determined by Insomnia Severity Index (ISI) score more than or equal to 15; Obstructive sleep apnea (OSA) determined by polysomnography (PSG) within 1 year with apnea- hypopnea index (AHI) more than or equal to 10 or any night oximetry 3% oxygen desaturation index (ODI) more than or equal to 10; any other sleep disorders determined by medical screening);
• 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 concealed. A random sequence of intervention order will be generated on a computer by an independent researcher not involved in participant recruitment. The intervention will only be revealed to
the researchers conducting the intervention after enrolment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by an independent investigator using 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
Feasibility outcomes analysis will be calculated using simple descriptive statistics.
EEG data will be compared between frontal versus sham and parietal versus sham conditions. Paired t-tests will be performed on matched EEG channels. The number of electrodes that reach significance (p<0.05) within the regions of interest (frontal and parietal), at an uncorrected level, will be reported. To compare the regions of interest (frontal and parietal), qualitative analysis by visual review of active condition versus sham topographical heat maps will be performed.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/07/2024
Actual
Date of last participant enrolment
Anticipated
9/09/2024
Actual
Date of last data collection
Anticipated
27/09/2024
Actual
Sample size
Target
5
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 26266 0
Woolcock Institute of Medical Research - Glebe
Recruitment postcode(s) [1] 42236 0
2113 - Macquarie Park

Funding & Sponsors
Funding source category [1] 316053 0
Charities/Societies/Foundations
Name [1] 316053 0
Centre for Chronic Diseases of Ageing at the Woolcock Institute of Medical Research
Country [1] 316053 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Woolcock Institute of Medical Research
Address
Country
Australia
Secondary sponsor category [1] 318214 0
None
Name [1] 318214 0
Address [1] 318214 0
Country [1] 318214 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314873 0
Macquarie University Human Research Ethics Committee Medical Sciences
Ethics committee address [1] 314873 0
Ethics committee country [1] 314873 0
Australia
Date submitted for ethics approval [1] 314873 0
19/02/2024
Approval date [1] 314873 0
04/04/2024
Ethics approval number [1] 314873 0

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

Contacts
Principal investigator
Name 133010 0
Dr Angela D’Rozario
Address 133010 0
Dr Angela D'Rozario, Woolcock Institute of Medical Research, 2 Innovation Rd, Macquarie Park NSW 2113
Country 133010 0
Australia
Phone 133010 0
+61 02 9805 3246
Fax 133010 0
Email 133010 0
[email protected]
Contact person for public queries
Name 133011 0
Josephine Tang
Address 133011 0
Woolcock Institute of Medical Research, 2 Innovation Rd, Macquarie Park NSW 2113
Country 133011 0
Australia
Phone 133011 0
+61 02 9805 3254
Fax 133011 0
Email 133011 0
[email protected]
Contact person for scientific queries
Name 133012 0
Josephine Tang
Address 133012 0
Woolcock Institute of Medical Research, 2 Innovation Rd, Macquarie Park NSW 2113
Country 133012 0
Australia
Phone 133012 0
+61 02 9805 3254
Fax 133012 0
Email 133012 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.