Recruiting

Sleep Therapy

Sponsor:

Brain Electrophysiology Laboratory Company

Code:

NCT05970276

Conditions

Sleep

Sleep Duration

Sleep Quality

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Accepted

Interventions

Deep Sleep (N3) Enhancement with TES

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 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. 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 improve sleep quality.

Conditions

Sleep

Sleep Duration

Sleep Quality

Study ID

NCT05970276

Start date

Feb 9, 2023

Status verified date

Jul, 2023

Completion date

Oct 31, 2023

Anticipated

Primary completion date

Oct 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Normally aging adults between the ages of 22-85

Exclusion Criteria:

  • 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

Study Design

Enrollment

30 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

Deep Sleep (N3) Enhancement with TES

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.

Primary outcome measure

  • Nocturnal duration of deep sleep assessed in minutes [ Time Frame: Measured during the nights of sleep (typically 8 hours) for up to three nights. ]

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, 97403

Contacts

Shijing Zhou, M.S.

541-579-6918shijing.zhou@bel.company

More Information

Sponsor

Brain Electrophysiology Laboratory Company

Last update posted

Aug 2, 2023

Last verified

Jul, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brain Electrophysiology Laboratory Company on 2023-08-02.