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Home Sleep Therapy for Older Adults With MCI

NCT05771844 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-02-17

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Transcranial Electrical Stimulation

Oscillating electrical current

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Wake Forest University

    collaborator OTHER

  • Brain Electrophysiology Laboratory Company

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-08
Primary Completion
2026-06-01
Completion
2026-06-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05771844 on ClinicalTrials.gov