Home Sleep Therapy for Older Adults With MCI
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Mild Cognitive Impairment, Sleep, Transcranial Electrical Stimulation, Machine Learning, Memory
In brief
The goal of this clinical trial is to learn about the ability of non-invasive brain stimulation during sleep to enhance people's deep sleep and its potential benefit on memory in people with mild cognitive impairment via home use sleep therapy device (SleepWISP) as well as learn about biomarkers associated with Alzheimer disease (AD). The clinical trial aims to answer the following main questions: 1. Whether the non-invasive transcranial electrical stimulation (TES) delivered by SleepWISP could provide short-term enhancement of deep sleep in a single night in the target population. 2. Whether TES delivered by SleepWISP could enhance deep sleep over multiple nights in the target population. 3. Whether enhance on deep sleep could improve memory performance in the target population. Participants will be asked to wear non-invasive and painless devices that record their brain activity during sleep along with an actigraphy watch that measures their movement throughout the day. In addition, blood samples or nasal swab assays will be collected from participants multiple times during the study.
Key facts
- Study ID
- NCT05771844
- Run by
- Brain Electrophysiology Laboratory Company
- People needed
- 60
- Starts
- 2023-02-08
- Expected to finish
- 2026-06-01
- Last updated by the study team
- 2025-02-17
Who can join
Age: 40 and older, up to 85. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 it is running
- Brain Electrophysiology Laboratory Company — Eugene, Oregon, United States (enrolling)
- Wake Forest University — Winston-Salem, North Carolina, United States
Full record on ClinicalTrials.gov
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