Home Sleep Therapy for Older Adults With MCI
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-85
SponsorBrain Electrophysiology Laboratory Company
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Transcranial Electrical Stimulation
Treatment groups
60 Participants
are divided into 1 treatment groupSponsors and collaborators
Brain Electrophysiology Laboratory Company
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Wake Forest University
Collaborator
Source ClinicalTrials.gov