Home Sleep Therapy for Older Adults With MCI

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.

Interventions

• Transcranial Electrical Stimulation · DEVICE

  Oscillating electrical current

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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

Sites (2)

• Wake Forest University, Winston-Salem, North Carolina · NOT_YET_RECRUITING
• Brain Electrophysiology Laboratory Company, Eugene, Oregon · RECRUITING