Home sleep therapy to improve memory in older adults with mild cognitive impairment
Home Sleep Therapy System for Mild Cognitive Impairment
This study tests if a new home sleep therapy device can help older adults with mild cognitive impairment sleep better and improve their memory.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Sponsor | Brain Electrophysiology Laboratory Company Industry-sponsored |
| Locations | 2 sites (Winston-Salem, North Carolina and 1 other locations) |
| Trial ID | NCT05771844 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of non-invasive transcranial electrical stimulation (TES) during sleep to enhance deep sleep in older adults with mild cognitive impairment (MCI). Participants will use a home sleep therapy device called SleepWISP, which records brain activity and stimulates the brain to potentially improve memory performance. The study aims to determine if TES can increase slow-wave sleep duration and explore biomarkers associated with Alzheimer’s disease. Participants will wear the device while sleeping, and their sleep patterns will be monitored over multiple nights.
Who should consider this trial
Good fit: Ideal candidates are older adults aged 55-85 with mild cognitive impairment or healthy volunteers aged 40-80.
Not a fit: Patients with a history of seizures, significant neurological diseases, or severe sleep disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance deep sleep and improve memory function in older adults with mild cognitive impairment.
How similar studies have performed: Previous pilot studies have shown that TES can enhance deep sleep in healthy individuals, suggesting potential for success in this population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * For participant with Amnestic MCI, the inclusion age range is 55-85 years old. * For healthy volunteers without MCI, the inclusion age range is 40-80 years old. Exclusion Criteria: * History of seizures * History of epilepsy * History of mod/severe brain injury or trauma (including neurosurgery) * History or presence of significant neurological disease such as Parkinson * History of Electroconvulsive Therapy (ECT) * Presence of severe insomnia * Presence of untreated sleep apnea * Presence of severe anxiety or depression * Medications that may affect the EEG * History of stroke * Sensitivity or allergy to lidocaine or silver * Presence of active suicidal ideation * Presence of metal in head or implants or medication infusion device * Pregnancy * Adverse reaction to TMS
Where this trial is running
Winston-Salem, North Carolina and 1 other locations
- Wake Forest University — Winston-Salem, North Carolina, United States (Not_yet_recruiting)
- Brain Electrophysiology Laboratory Company — Eugene, Oregon, United States (Recruiting)
Study contacts
- Study coordinator: Don M Tucker, PhD
- Email: don.tucker@bel.company
- Phone: 541-653-8266
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.