RECRUITING

Home Sleep Therapy for Older Adults With MCI

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Home Sleep Therapy System for Mild Cognitive Impairment

Quick Facts

Study Start:2023-02-08
Study Completion:2026-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05771844

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.

Ages Eligible for Study:40 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * For participant with Amnestic MCI, the inclusion age range is 55-85 years old.
  2. * For healthy volunteers without MCI, the inclusion age range is 40-80 years old.
  1. * History of seizures
  2. * History of epilepsy
  3. * History of mod/severe brain injury or trauma (including neurosurgery)
  4. * History or presence of significant neurological disease such as Parkinson
  5. * History of Electroconvulsive Therapy (ECT)
  6. * Presence of severe insomnia
  7. * Presence of untreated sleep apnea
  8. * Presence of severe anxiety or depression
  9. * Medications that may affect the EEG
  10. * History of stroke
  11. * Sensitivity or allergy to lidocaine or silver
  12. * Presence of active suicidal ideation
  13. * Presence of metal in head or implants or medication infusion device
  14. * Pregnancy
  15. * Adverse reaction to TMS

Contacts and Locations

Study Contact

Don M Tucker, PhD
CONTACT
541-653-8266
don.tucker@bel.company
Phan Luu, PhD
CONTACT
541-653-9797
phan.luu@bel.company

Study Locations (Sites)

Wake Forest University
Winston-Salem, North Carolina, 27109
United States
Brain Electrophysiology Laboratory Company
Eugene, Oregon, 97405
United States

Collaborators and Investigators

Sponsor: Brain Electrophysiology Laboratory Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-08
Study Completion Date2026-06-01

Study Record Updates

Study Start Date2023-02-08
Study Completion Date2026-06-01

Terms related to this study

Keywords Provided by Researchers

  • Slow Wave Sleep
  • NREM N3 Sleep

Additional Relevant MeSH Terms

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