Non-Invasive At-Home Sleep Therapy System

NCT05970276 | Unknown DMC FDA Device

• 1 other identifier: HSHEALTHY
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 healthy adults via home use sleep therapy device (SleepWISP). Participants will be asked to wear non-invasive and painless devices that record their brain activity during sleep. 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 improve sleep quality.

Conditions

Sleep; Sleep Duration; Sleep Quality

Outcome Measures

Primary Outcomes (1)

• Nocturnal duration of deep sleep assessed in minutes

  Duration in minutes of N3 sleep

  Measured during the nights of sleep (typically 8 hours) for up to three nights.

Secondary Outcomes (1)

• Nocturnal sleep quality assessed by Pittsburgh Sleep Quality Index (PSQI)

  Measured after each night of sleep in the following morning for up to three nights.

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: Deep Sleep (N3) Enhancement with TES

Interventions

Deep Sleep (N3) Enhancement with TES DEVICE

As participants sleep, their sleep EEG will be measured and automatically scored by the computer to determine stage of sleep. When slow wave sleep is detected, low-level current (.5-1 mA total) will be applied through pre-set electrodes.

Also known as: SleepWISP TES

Deep Sleep Enhancement with TES

Eligibility Criteria

• Age: 22 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Normally aging adults between the ages of 22-85

You may not qualify if:

• History of seizures
• History of epilepsy
• History of 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 sleep apnea
• Presence of severe anxiety or depression
• Taking 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

Study Sites (1)

Brain Electrophysiology Laboratory Company

Eugene, Oregon, 97403, United States

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

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 they receive the stimulation.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All participants receive same amount of TES stimulations, but in randomized order (stimulation either on the second night or the last night).

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: August 1, 2023
• Study Start: February 9, 2023
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: August 2, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)