Home Sleep Therapy System for Mild Cognitive Impairment

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 85
Healthy Volunteers: t
View:

• 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.

Locations
United States
North Carolina
Wake Forest University
NOT_YET_RECRUITING
Winston-salem
Oregon
Brain Electrophysiology Laboratory Company
RECRUITING
Eugene
Contact Information
Primary
Don M Tucker, PhD
don.tucker@bel.company
541-653-8266
Backup
Phan Luu, PhD
phan.luu@bel.company
541-653-9797
Time Frame
Start Date: 2023-02-08
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 60
Treatments
Experimental: Deep Sleep Enhancement with TES
Transcranial Electrical Stimulation, 0.5 Hz sine wave, 0.5 mA, between frontal (frontopolar and inferior lateral frontal) and posterior (mastoid and occipital) electrodes.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Aging (NIA), Wake Forest University
Leads: Brain Electrophysiology Laboratory Company

This content was sourced from clinicaltrials.gov