Recruiting

Home Sleep Therapy

Sponsor:

Brain Electrophysiology Laboratory Company

Code:

NCT05771844

Conditions

Mild Cognitive Impairment

Sleep

Transcranial Electrical Stimulation

Machine Learning

Memory

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

Interventions

Transcranial Electrical Stimulation

Study Details

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. 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.

Conditions

Mild Cognitive Impairment

Sleep

Transcranial Electrical Stimulation

Machine Learning

Memory

Study ID

NCT05771844

Start date

Feb 8, 2023

Status verified date

Feb, 2025

Completion date

Jun 1, 2026

Anticipated

Primary completion date

Jun 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Deep Sleep Enhancement with TES

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

Interventions

Transcranial Electrical Stimulation

Oscillating electrical current

Primary outcome measure

  • Device Usability [ Time Frame: 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 [ Time Frame: Measured during the nights of sleep (typically 8 hours) across both phases of the study ]
  • Percentage of N3 Sleep [ Time Frame: Measured during the nights of sleep (typically 8 hours) across both phases of the study ]

Central Contacts and Locations

Central contacts

Don M Tucker, PhD

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

Phan Luu, PhD

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

Locations

Brain Electrophysiology Laboratory Company

Recruiting

Eugene, Oregon, United States, 97405

Contacts

Don M Tucker, PhD

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

Phan Luu, PhD

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

More Information

Sponsor

Brain Electrophysiology Laboratory Company

Last update posted

Feb 17, 2025

Last verified

Feb, 2025

Keywords

  • Slow Wave Sleep
  • NREM N3 Sleep

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-14. This information was provided to ClinicalTrials.gov by Brain Electrophysiology Laboratory Company on 2025-02-17. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.