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
This trial accepts healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Transcranial Electrical Stimulation
DeviceOscillating electrical current
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Deep Sleep Enhancement with TESExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Device Usability
Criteria for success: the prototype is safe for all participants, and it is usable at home by 80% of adults with MCI. Specific outcome ratings (5-point Lickert scale) will be obtained for (1) ability to clean the device, (2) ability to apply the device, (3) ability to turn on the tablet (launching the dedicated software); (4) ability to start treatment; (5) ability to complete treatment.
Time frame
Collected each day they use the Sleep WISP system, for three sessions over 10 days during Phase I of the study.2
Duration of N3 Sleep
Duration in minutes of N3 sleep
Time frame
Measured during the nights of sleep (typically 8 hours) across both phases of the study3
Percentage of N3 Sleep
Percentage of the night's sleep spent in N3
Time frame
Measured during the nights of sleep (typically 8 hours) across both phases of the studySecondary outcomes
1
Memory Performance; Paired-Associates Verbal Learning (PAVL)
10 pairs of unrelated, neutral-valence nouns are learned each night before sleep. Participants are tested in the morning when an online program provides the first word of the pair and they type in the second word that went with it (cued recall). More accurately recalled pairs of words (0-10 pairs) indicates better memory performance.
Time frame
Measured at the beginning as baseline, then once weekly over the course of study, and then once on the last day of the study, for a total of up to 7 times.2
Beck Depression Inventory (BDI)
Assessment of psychiatric symptomatology; 21-item self-reported inventory that measures symptoms of depression. Responses are weighted and a higher score (1-40) indicates higher levels of depression.
Time frame
Measured at the beginning as baseline, then once weekly over the course of study, and then once on the last day of the study, for a total of up to 7 times.3
Beta Amyloid Excretion Blood Sample or Nasal Swab Assay
Collected for exploratory analysis on biomarkers associated with Alzheimer's disease and treated with an anticoagulant, plasma isolated and stored at -80 until Aβ detection. Aβ40 and 42 detection will be performed using a commercially-available immunoassay (Innotest, Fugirebio).
Time frame
Collected on the first day of Phase II of the study, and then the end of each week in Phase II, for a total of up to 7 times.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Brain Electrophysiology Laboratory Company
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Wake Forest University
Collaborator
Source ClinicalTrials.gov