SleepEarly Phase 1ESSOTEDSNCT04461769
Electrical Synchronization of Slow Oscillations to Enhance Deep Sleep
A Early Phase 1 study testing Transcranial Electrical Stimulation in people with Sleep and Sleep Hygiene, run by Brain Electrophysiology Laboratory Company at 1 site in United States.
Trial summary
This study applied slowly oscillating (0.5 hz) transcranial electrical stimulation (TES; frontopolar and lateral frontal electrodes versus mastoid and occipital electrode returns) to synchronize the endogenous slow oscillations (SOs) of deep sleep (N3 or stage 3 Non-REM). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Sleep Hygiene
- What is being tested?
- Transcranial Electrical Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to 30 May 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -
Who cannot join
- history of seizures
- epilepsy
- brain trauma or injury
- insomnia
- sleep apnea
- medications that may affect the EEG.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brain Electrophysiology Laboratory Company
Eugene, Oregon, 97405
About this study
This study applied slowly oscillating (0.5 hz) transcranial electrical stimulation (TES; frontopolar and lateral frontal electrodes versus mastoid and occipital electrode returns) to synchronize the endogenous slow oscillations (SOs) of deep sleep (N3 or stage 3 Non-REM). A double-blind placebo control provided no stimulation. The primary endpoint was duration of N3 sleep during the night. Thirteen normal adults completed the study (before the study was terminated because of COVID-19), and usable data were obtained from ten. The synchronizing stimulation resulted in significantly longer N3 sleep compared to placebo.
Read the detailed description
Previous studies have demonstrated successful synchronization of SOs with slow TES pulses. However, the stimulation in those studies used electrodes in dorsolateral frontal areas (F3, F4 versus contralateral mastoids), consistent with the assumption that human SOs emanate from frontal neocortex. In the present study, we hypothesized that transcranial electrical stimulation (TES) could be applied to frontopolar and inferior frontal head sites in order to synchronize the limbic sources of SOs specifically and thereby enhance the duration of N3 sleep. Furthermore, based on our computational modeling with this more optimal targeting of the limbic sites, we hypothesized that we could use lower TES current levels (0.5 mA versus 1 or 2 mA in previous studies) that would be unlikely to disrupt sleep and that may still be successful in synchronizing SOs to enhance the adaptive neurophysiology of deep sleep.
- Conditions
- Sleep, Sleep Hygiene
- Being tested
- Transcranial Electrical Stimulation
- Medical subject headings
- Sleep Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Electrical StimulationDevice
Also called Sleep WISP (Wireless Interface Sensor Pod)
Oscillating electrical current
| Study group | Role | What they receive |
|---|---|---|
| Slow Oscillation Synchronization with TES | Experimental | Transcranial Electrical Stimulation, 0.5 Hz sine wave, 0.5 mA, between frontal (frontopolar and inferior lateral frontal) and posterior (mastoid and occipital) electrodes. Receives: Device: Transcranial Electrical Stimulation |
| Sham Control | Sham comparator | No current delivered. Receives: Device: Transcranial Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
N3 Duration
Duration in minutes of N3 sleep
Measured: Measured during the night of sleep (typically 8 hours)
Secondary outcomes (1)
N3 Percentage
Percentage of the night's sleep spent in N3
Measured: Measured during the night of sleep (typically 8 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start1 Sep 2019
- Primary completion30 May 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- First night adaptation sleep; second and third nights (one week apart) stimulation or placebo control (order randomized).
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brain Electrophysiology Laboratory Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04461769
- Sponsor's protocol ID
- R44MH115955
- Acronym
- ESSOTEDS
- Status last verified
- Jul 2020
- First submitted
- 30 Jun 2020
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Synchronization of Slow Oscillations to Enhance Deep Sleep
- ClinicalTrials.gov ID
- NCT04461769
- Acronym / sponsor ID
- ESSOTEDS / R44MH115955
- Conditions
- Sleep, Sleep Hygiene
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Brain Electrophysiology Laboratory CompanyIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 8 Jul 2020 (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.
This study applied slowly oscillating (0.5 hz) transcranial electrical stimulation (TES; frontopolar and lateral frontal electrodes versus mastoid and occipital electrode returns) to synchronize the endogenous slow oscillations (SOs) of deep sleep (N3 or stage 3 Non-REM). A double-blind placebo control provided no stimulation. The primary endpoint was duration of N3 sleep during the night. Thirteen normal adults completed the study (before the study was terminated because of COVID-19), and usable data were obtained from ten. The synchronizing stimulation resulted in significantly longer N3 sleep compared to placebo.
Detailed description
Previous studies have demonstrated successful synchronization of SOs with slow TES pulses. However, the stimulation in those studies used electrodes in dorsolateral frontal areas (F3, F4 versus contralateral mastoids), consistent with the assumption that human SOs emanate from frontal neocortex. In the present study, we hypothesized that transcranial electrical stimulation (TES) could be applied to frontopolar and inferior frontal head sites in order to synchronize the limbic sources of SOs specifically and thereby enhance the duration of N3 sleep. Furthermore, based on our computational modeling with this more optimal targeting of the limbic sites, we hypothesized that we could use lower TES current levels (0.5 mA versus 1 or 2 mA in previous studies) that would be unlikely to disrupt sleep and that may still be successful in synchronizing SOs to enhance the adaptive neurophysiology of deep sleep.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- First night adaptation sleep; second and third nights (one week apart) stimulation or placebo control (order randomized).
| Arm | Type | Receives |
|---|---|---|
| Slow Oscillation Synchronization with TES | Experimental | Device: Transcranial Electrical StimulationTranscranial Electrical Stimulation, 0.5 Hz sine wave, 0.5 mA, between frontal (frontopolar and inferior lateral frontal) and posterior (mastoid and occipital) electrodes. |
| Sham Control | Sham comparator | Device: Transcranial Electrical StimulationNo current delivered. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (6 listed)
- history of seizures
- epilepsy
- brain trauma or injury
- insomnia
- sleep apnea
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 |
|---|---|---|
| Transcranial Electrical StimulationAlso: Sleep WISP (Wireless Interface Sensor Pod)Oscillating electrical current | Device | Sham Control, Slow Oscillation Synchronization with TES |
Primary outcome
N3 Duration
Time frame: Measured during the night of sleep (typically 8 hours)
Duration in minutes of N3 sleep
1 secondary outcome
N3 Percentage
Time frame: Measured during the night of sleep (typically 8 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Individual participant dataSharing planned: No
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Healthy Adult Participants
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 Early Phase 1 study testing Transcranial Electrical Stimulation in people with Sleep and Sleep Hygiene, run by Brain Electrophysiology Laboratory Company 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 6 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: finished, as of the sponsor's last update on 8 Jul 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
N3 Duration (time frame: Measured during the night of sleep (typically 8 hours)). 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 Jul 2020.