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Home Sleep Therapy for Older Adults With MCI

Brain Electrophysiology Laboratory Company · with National Institute on Aging (NIA), Wake Forest University · NCT05771844

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 40–85 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
60
US sites recruiting
1
Study start
February 8, 2023
Record last updated
February 17, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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:

  • 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.
  • Whether TES delivered by SleepWISP could enhance deep sleep over multiple nights in the target population.
  • 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.

Being studied: Transcranial Electrical Stimulation

Conditions: Mild Cognitive Impairment; Sleep; Transcranial Electrical Stimulation; Machine Learning; Memory

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion 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.

Exclusion Criteria

  • 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

Recruiting US locations

  • Brain Electrophysiology Laboratory Company

    Eugene, OR 97405

    Site contact: Don M Tucker, PhD · 541-653-8266 · don.tucker@bel.company

Study contacts (from the official record)

  • Don M Tucker, PhD · 541-653-8266 · don.tucker@bel.company
  • Phan Luu, PhD · 541-653-9797 · phan.luu@bel.company
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Home Sleep Therapy for Older Adults With MCI (NCT05771844) | Bored Studies