The Assessment of Human Sleep and Its Functions (SS_Sleep)

StimScience Inc.

Status: Active, not recruiting

Conditions: Insomnia

Treatments: Other: sham tES; Other: Fixed tES; Other: Personalized tES

Study type: Interventional

Funder types: Industry

Identifiers

NCT07211646

19042

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,000 participants in 1 patient group

tES Stimulation

Experimental group

Description:

Within person group to test different interventions in randomized order

Treatment:

Other: Personalized tES

Other: Fixed tES

Other: sham tES