None listed
Conditions
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.
Interventions
Proof of concept/ Feasibility study.
We aim to assess if it is feasible to apply slow oscillation-transcranial direct current stimulation to two regions, frontal and parietal, to enhance slow wave activity 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
Proof of concept/ Feasibility study. We aim to assess if it is feasible to apply slow oscillation-transcranial direct current stimulation to two regions, frontal and parietal, to enhance slow wave activity 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.
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
No
Inclusion criteria
Moderate to severe OSA (polysomnography (PSG) within 1 year with AHI greater than or equal to 15 or any night oximetry 3% ODI greater than or 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.
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 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 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 greater than or equal to 12); • Are unable to easily nap in the afternoon (determined by questionnaire).
Outcome results
None listed