The Assessment of Human Sleep and Its Functions

Not Applicable

Active, not recruiting

• Conditions: Insomnia

• Registration Number: NCT07211646
• Lead Sponsor: StimScience Inc.

Brief Summary

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

Detailed Description

The purpose of this study is to see the effects of targeted brain stimulation when falling asleep and on sleep quality. The study uses non-invasive Transcranial Electrical Stimulation (tES), and/or a standard electroencephalogram (EEG). We may also measure eye movements, muscle activity, and heart rhythm. We may play audio during the stimulation.

The sessions can include full overnight sleep or short nap session.

Study Timeline

• Study Start: 2019-05-20
• Status Verified: 2025-09
• Study First Submitted: 2025-09-23
• Study First Submitted QC: 2025-09-30
• Last Update Submitted: 2025-09-30
• Study First Posted: 2025-10-08
• Last Update Posted: 2025-10-08
• Primary Completion: 2028-12
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• 18-75 year olds

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Sleep Efficiency Change	up to 6 weeks	Sleep efficiency (time slept as a percentage time spent in bed) changes across the different interventions for each subject and aggregate that across subjects
Sleep Onset Change	1 day to 6 weeks	Changes in time to fall asleep across the different interventions for each subject and aggregate that across subjects

Trial Locations

Locations (1)

StimScience; 🇺🇸 Berkeley, California, United States