Home Sleep Therapy for Older Adults With MCI

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Brain Electrophysiology Laboratory Company
Study ID
NCT05771844
Status
Recruiting
Apply to this trial

Conditions

  • Machine Learning
  • Memory
  • Mild Cognitive Impairment
  • Sleep
  • Transcranial Electrical Stimulation

Eligibility Criteria

Sex
ALL
Age
40 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • Transcranial Electrical Stimulation — DEVICE
    Oscillating electrical current

Study Details

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 Dates

Start date
Feb 8, 2023
Status verified
Feb 2025
Primary completion
Jun 1, 2026
Completion
Jun 1, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Device Usability [ Time Frame: Collected each day they use the Sleep WISP system, for three sessions over 10 days during Phase I of the study. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Wake Forest UniversityWinston-SalemNorth Carolina27109
Ruth Benca, PhD
[email protected]
Caitlin Carroll, PhD
[email protected]
Brain Electrophysiology Laboratory CompanyEugeneOregon97405
Don M Tucker, PhD
[email protected]
541-653-8266
Phan Luu, PhD
[email protected]
541-653-9797

Find similar trials in Winston-Salem, NC

By research site
Wake Forest University· Winston-Salem, NCBrain Electrophysiology Laboratory Company· Eugene, OR

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