Home Sleep Therapy for Older Adults With MCI

Description

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.

Conditions

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

Study Overview

Study Details

Study overview

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.

Home Sleep Therapy System for Mild Cognitive Impairment

Home Sleep Therapy for Older Adults With MCI

Condition
Mild Cognitive Impairment
Intervention / Treatment

-

Contacts and Locations

Winston-Salem

Wake Forest University, Winston-Salem, North Carolina, United States, 27109

Eugene

Brain Electrophysiology Laboratory Company, Eugene, Oregon, United States, 97405

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

40 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Brain Electrophysiology Laboratory Company,

Study Record Dates

2026-06-01