NCT07211646

Brief Summary

The purpose of this study is to look at the effects of targeted brain stimulation when falling asleep and on sleep quality.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
31mo left

Started May 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
May 2019Dec 2028

Study Start

First participant enrolled

May 20, 2019

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 8, 2025

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

October 8, 2025

Status Verified

September 1, 2025

Enrollment Period

9.5 years

First QC Date

September 23, 2025

Last Update Submit

September 30, 2025

Conditions

Insomnia

Keywords

tES intervention for Sleep

Outcome Measures

Primary Outcomes (2)

  • Sleep Efficiency Change

    Sleep efficiency (time slept as a percentage time spent in bed) changes across the different interventions for each subject and aggregate that across subjects

    up to 6 weeks

  • Sleep Onset Change

    Changes in time to fall asleep across the different interventions for each subject and aggregate that across subjects

    1 day to 6 weeks

Study Arms (1)

tES Stimulation

EXPERIMENTAL

Within person group to test different interventions in randomized order

Other: sham tESOther: Fixed tESOther: Personalized tES

Interventions

sham tESOTHER

short 30s sham stimulation

tES Stimulation
Fixed tESOTHER

Fixed stimulation parameters for all participants

tES Stimulation
Personalized tESOTHER

Stimulation parameters personalized for each participant

tES Stimulation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • year olds

You may not qualify if:

  • Epilepsy
  • Seizure History
  • Serious head injury or brain surgery
  • Migraines
  • Metal implants in head
  • Pacemaker or implanted devices
  • Pregnancy
  • Any serious medical condition other than insomnia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

StimScience

Berkeley, California, 94704, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Participants randomly get control or sham, vs. stimulation variations
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2025

First Posted

October 8, 2025

Study Start

May 20, 2019

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

October 8, 2025

Record last verified: 2025-09

Locations

US(1)