InsomniaSS_SleepNCT07211646
The Assessment of Human Sleep and Its Functions
A study testing Fixed tES and Personalized tES in people with Insomnia, run by StimScience Inc. at 1 site in United States.
Trial summary
The purpose of this study is to look at the effects of targeted brain stimulation when falling asleep and on sleep quality. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- Fixed tES and Personalized tES
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2019to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-75 year olds
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to look at the effects of targeted brain stimulation when falling asleep and on sleep quality.
Read the 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.
- Conditions
- Insomnia
- Being tested
- sham tES, Fixed tES, Personalized tES
- Keywords
- tES intervention for Sleep
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sham tESOther
short 30s sham stimulation
Fixed tESOther
Fixed stimulation parameters for all participants
Personalized tESOther
Stimulation parameters personalized for each participant
| Study group | Role | What they receive |
|---|---|---|
| tES Stimulation | Experimental | Within person group to test different interventions in randomized order Receives: Other: sham tES; Other: Fixed tES; Other: Personalized tES |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 1 day to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start20 May 2019
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants randomly get control or sham, vs. stimulation variations
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- StimScience Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211646
- Sponsor's protocol ID
- 19042
- Acronym
- SS_Sleep
- Status last verified
- Sep 2025
- First submitted
- 23 Sep 2025
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment of Human Sleep and Its Functions
- ClinicalTrials.gov ID
- NCT07211646
- Acronym / sponsor ID
- SS_Sleep / 19042
- Conditions
- Insomnia
- Keywords
- tES intervention for Sleep
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- StimScience Inc.Industry (pharma, biotech, devices)
- Study start
- 20 May 2019 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 8 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants randomly get control or sham, vs. stimulation variations
| Arm | Type | Receives |
|---|---|---|
| tES Stimulation | Experimental | Other: sham tES, Other: Fixed tES, Other: Personalized tESWithin person group to test different interventions in randomized order |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18-75 year olds
Key exclusion criteria (8 listed)
- Epilepsy
- Seizure History
- Serious head injury or brain surgery
- Migraines
- Metal implants in head
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sham tESshort 30s sham stimulation | Other | tES Stimulation |
| Fixed tESFixed stimulation parameters for all participants | Other | tES Stimulation |
| Personalized tESStimulation parameters personalized for each participant | Other | tES Stimulation |
Primary outcome
Sleep Efficiency Change
Time frame: 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
Time frame: 1 day to 6 weeks
Changes in time to fall asleep across the different interventions for each subject and aggregate that across subjects
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fixed tES and Personalized tES in people with Insomnia, run by StimScience Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Efficiency Change (time frame: up to 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2025.