The effects of neuromodulation on sleep and cognition in healthy older adults: A proof-of-concept study

Not Applicable

Recruiting

• Conditions: Mild cognitive impairment; Alzheimer’s Disease; Dementia; Neurological - Neurodegenerative diseases

• Registration Number: ACTRN12624000839505
• Lead Sponsor: Woolcock Institute of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-08
• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 5

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Technical feasibility. This will be assessed as a composite outcome. [Technical feasibility will be measured by the percentage of randomised participants successfully reaching stable NREM sleep, completing the stimulation blocks and having EEG recorded in the post stimulation blocks. Success will be defined by 80% of randomised participants reaching stable NREM (N2 and N3) sleep (determined by visual analysis of the EEG data), completing all five stimulation blocks (determined by a checklist) and having EEG measured during the post stimulation blocks (determined by EEG data) in at least one active and the sham condition. Technical feasibility will be measured at each visit and calculated at the end of the study. ]