Electrical Synchronization of Slow Oscillations to Enhance Deep Sleep

NCT04461769 | Completed Early Phase 1

• 1 other identifier: R44MH115955
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This study applied slowly oscillating (0.5 hz) transcranial electrical stimulation (TES; frontopolar and lateral frontal electrodes versus mastoid and occipital electrode returns) to synchronize the endogenous slow oscillations (SOs) of deep sleep (N3 or stage 3 Non-REM). A double-blind placebo control provided no stimulation. The primary endpoint was duration of N3 sleep during the night. Thirteen normal adults completed the study (before the study was terminated because of COVID-19), and usable data were obtained from ten. The synchronizing stimulation resulted in significantly longer N3 sleep compared to placebo.

Conditions

Sleep; Sleep Hygiene

Outcome Measures

Primary Outcomes (1)

• N3 Duration

  Duration in minutes of N3 sleep

  Measured during the night of sleep (typically 8 hours)

Secondary Outcomes (1)

• N3 Percentage

  Measured during the night of sleep (typically 8 hours)

Study Arms (2)

Slow Oscillation Synchronization 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

Sham Control

SHAM COMPARATOR

No current delivered.

Device: Transcranial Electrical Stimulation

Interventions

Transcranial Electrical Stimulation DEVICE

Oscillating electrical current

Also known as: Sleep WISP (Wireless Interface Sensor Pod)

Sham Control; Slow Oscillation Synchronization with TES

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• history of seizures
• epilepsy
• brain trauma or injury
• insomnia
• sleep apnea
• medications that may affect the EEG.

Sponsors & Collaborators

• Brain Electrophysiology Laboratory Company: lead

Study Sites (1)

Brain Electrophysiology Laboratory Company

Eugene, Oregon, 97405, United States

Location

MeSH Terms

Conditions

Sleep Hygiene

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participants were blind to which night was stimulation. Experimenters were blinded until the participant was asleep, when they opened an email that specified delivery of stimulation or sham.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: First night adaptation sleep; second and third nights (one week apart) stimulation or placebo control (order randomized).

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 8, 2020
• Study Start: September 1, 2019
• Primary Completion: May 30, 2020
• Study Completion: May 30, 2020
• Last Updated: July 8, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)