Home Sleep Therapy for Older Adults With MCI

NCT05771844 | Recruiting DMC FDA Device

• 2 other identifiers: 1R44AG0779651R44AG077965-01A1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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. 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. 2.Whether TES delivered by SleepWISP could enhance deep sleep over multiple nights in the target population.
3. 3.Whether enhance on deep sleep could improve memory performance in the target population.

Conditions

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

Keywords

Slow Wave Sleep; NREM N3 Sleep

Outcome Measures

Primary Outcomes (3)

• 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.

  Collected each day they use the Sleep WISP system, for three sessions over 10 days during Phase I of the study.

• Duration of N3 Sleep

  Duration in minutes of N3 sleep

  Measured during the nights of sleep (typically 8 hours) across both phases of the study

• Percentage of N3 Sleep

  Percentage of the night's sleep spent in N3

  Measured during the nights of sleep (typically 8 hours) across both phases of the study

Secondary Outcomes (3)

• Memory Performance; Paired-Associates Verbal Learning (PAVL)

  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.

• Beck Depression Inventory (BDI)

  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.

• Beta Amyloid Excretion Blood Sample or Nasal Swab Assay

  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.

Study Arms (1)

Deep Sleep Enhancement with TES

EXPERIMENTAL

Transcranial Electrical Stimulation, 0.5 Hz sine wave, 0.5 mA, between frontal (frontopolar and inferior lateral frontal) and posterior (mastoid and occipital) electrodes.

Device: Transcranial Electrical Stimulation

Interventions

Transcranial Electrical Stimulation DEVICE

Oscillating electrical current

Also known as: SleepWISP (Wireless Interface Sensor Pod)

Deep Sleep Enhancement with TES

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Brain Electrophysiology Laboratory Company: lead
• National Institute on Aging (NIA): collaborator
• Wake Forest University: collaborator

Study Sites (2)

Wake Forest University

Winston-Salem, North Carolina, 27109, United States

NOT YET RECRUITING

Brain Electrophysiology Laboratory Company

Eugene, Oregon, 97405, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Don M Tucker, PhD

CONTACT

541-653-8266; don.tucker@bel.company

Phan Luu, PhD

CONTACT

541-653-9797; phan.luu@bel.company

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: All participants receive same amount of TES stimulations over the course of the study, but they are blind to which night or blocks of 2 weeks they receive the stimulation in Phases I and II of the study (stimulation either on the second night or the last night of Phase I and stimulation on either the first or last block of 2 weeks in Phase II).
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: During Phase I of the study, all participants receive the same amount of TES stimulations, but in randomized order (stimulation either on the second night or the last night of Phase I). All participants receive stimulation and placebo in Phase II on a daily basis for up to two weeks at a time. The order participants receive placebo or treatment in the two week blocks are randomized.

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 16, 2023
• Study Start: February 8, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 17, 2025

Record last verified: 2025-02

Locations

US (2)