None listed
Conditions
Brief summary
Ageing is associated with poor sleep which can contribute to cognitive decline. Non-invasive low current brain stimulation has been used as a method to enhance deep sleep in healthy adults and in some cases improve memory performance. However, intervention outcomes on sleep and memory were inconclusive across the different studies. This proof-of-concept study uses a new technique of brain stimulation which can target more specific brain areas compared to previous methods. This proof-of-concept study aims to evaluate the feasibility of applying high-definition slow oscillatory transcranial direct current stimulation (so-tDCS) in two brain regions – frontal and parietal, and assess the effects on slow oscillation activity during sleep in a middle to late aged healthy population. Participants will attend three in-person visits at the Woolcock Institute of Medical Research where they will receive low current brain stimulation during a nap. Participants will also complete cognitive tasks before and after the nap.
Interventions
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 throu
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.
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 day 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 throug
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 day 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.
Sponsors
Woolcock Institute of Medical Research
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to 65 Years
Healthy volunteers
Yes
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.
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).
Outcome results
None listed