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The Assessment of Human Sleep and Its Functions

The Assessment of Human Sleep and Its Functions

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07211646
Acronym
SS_Sleep
Enrollment
1000
Registered
2025-10-08
Start date
2019-05-20
Completion date
2028-12-31
Last updated
2025-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

Keywords

tES intervention for Sleep

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.

Interventions

short 30s sham stimulation

OTHERFixed tES

Fixed stimulation parameters for all participants

OTHERPersonalized tES

Stimulation parameters personalized for each participant

Sponsors

StimScience Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Participants randomly get control or sham, vs. stimulation variations

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Sleep Efficiency Changeup to 6 weeksSleep 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 Change1 day to 6 weeksChanges in time to fall asleep across the different interventions for each subject and aggregate that across subjects

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026