SleepNCT05970276
Non-Invasive At-Home Sleep Therapy System
A study testing Deep Sleep (N3) Enhancement with TES in people with Sleep and Sleep Duration, run by Brain Electrophysiology Laboratory Company at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn about the ability of non-invasive brain stimulation during sleep to enhance people's deep sleep and its potential benefit on memory in healthy adults via home use sleep therapy device (SleepWISP). Read more about this study
- Who is it for?
- Ages 22 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Sleep Duration, Sleep Quality
- What is being tested?
- Deep Sleep (N3) Enhancement with TES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2023to 31 Oct 2023
- Phase
- Interventional
- 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 22 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normally aging adults between the ages of 22-85
Who cannot join
- History of seizures
- History of epilepsy
- History of brain injury or trauma (including neurosurgery)
- History or presence of significant neurological disease such as Parkinson
- History of Electroconvulsive Therapy (ECT)
- Presence of severe insomnia
Show all 15Show fewer
- Presence of sleep apnea
- Presence of severe anxiety or depression
- Taking medications that may affect the EEG
- History of stroke
- Sensitivity or allergy to lidocaine or silver
- Presence of active suicidal ideation
- Presence of metal in head or implants or medication infusion device
- Pregnancy
- Adverse reaction to TMS
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Brain Electrophysiology Laboratory Company
Eugene, Oregon, 97403
Shijing Zhou, M.S., 541-579-6918, shijing.zhou@bel.company
About this study
The goal of this clinical trial is to learn about the ability of non-invasive brain stimulation during sleep to enhance people's deep sleep and its potential benefit on memory in healthy adults via home use sleep therapy device (SleepWISP). Participants will be asked to wear non-invasive and painless devices that record their brain activity during sleep. The clinical trial aims to answer the following main questions:
- Whether the non-invasive transcranial electrical stimulation (TES) delivered by SleepWISP could provide short-term enhancement of deep sleep in a single night in the target population.
- Whether TES delivered by SleepWISP could improve sleep quality.
Read the detailed description
The purpose of the present research is to evaluate the ability of non-invasive transcranial electrical stimulation (TES) during slow-wave sleep (SWS) to enhance this stage of sleep. It has been demonstrated, in a pilot study, that TES can acutely (i.e., immediately after TES) increase SWS duration. In the present proposal, the study aim to replicate and extend the pilot findings. More specifically, it is proposed to conduct a sleep study using the Brain Electrophysiology Laboratory (BEL) company's Sleep WISP device (described in detail below). The Sleep WISP device is made up of three components: 1) 16-channel EEG amplifier with transcranial electrical stimulation (TES) capabilities, 2) a 16-channel EEG headband and 3) a small portable computer.
All participants will be provided a Sleep WISP device. Participation in the study requires that participants use the Sleep WISP when they sleep. As participants sleep, their sleep EEG will be measured and automatically scored by the computer to determine stage of sleep. When SWS is detected, low-level current (.5-1 mA total) will be applied through pre-set electrodes (four on the forehead and four at base of back of head). These electrodes were used in our pilot study, showing that current applied through these electrodes during SWS is able to increase total SWS sleep duration.
The study involves up to three nights of sleep. All sleep session will be at home. The first session is a baseline/acclimation session. In the first session, participants will use the Sleep WISP device to passively record sleep EEG (no TES) as baseline. The second session is performed the night following the baseline session with randomized experiment condition (either placebo or active TES session). Participants will be blinded for what condition they receive. The final session will occur one week after the second session to receive the opposite experiment condition to the second session.
In our previous TES study of SWS enhancement in the BEL lab, the investigators were able to show that SWS can be enhanced immediately (short-term/acute) after TES. The proposed new study will extend the previous pilot in-lab study results by using Sleep WISP device at home, which will allow us to support home EEG sleep monitoring and acute sleep therapy.
Aim 1: The study aims to replicate our previous in-lab study (acute/short-term enhancement of SWS) with Sleep WISP device at home for deep sleep enhance.
Aim 2: The study aims to investigate any change on sleep quality associated with TES sleep therapy delivered by Sleep WISP device.
- Conditions
- Sleep, Sleep Duration, Sleep Quality
- Being tested
- Deep Sleep (N3) Enhancement with TES
- 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.
Deep Sleep (N3) Enhancement with TESDevice
Also called SleepWISP TES
As participants sleep, their sleep EEG will be measured and automatically scored by the computer to determine stage of sleep. When slow wave sleep is detected, low-level current (.5-1 mA total) will be applied through pre-set electrodes.
| Study group | Role | What they receive |
|---|---|---|
| Deep Sleep Enhancement 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: Deep Sleep (N3) Enhancement with TES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nocturnal duration of deep sleep assessed in minutes
Duration in minutes of N3 sleep
Measured: Measured during the nights of sleep (typically 8 hours) for up to three nights.
Secondary outcomes (1)
Nocturnal sleep quality assessed by Pittsburgh Sleep Quality Index (PSQI)
Measured by the Pittsburgh Sleep Quality Index (PSQI). The PSQI score can range from 0 to 21 with higher scores indicating worse sleep quality.
Measured: Measured after each night of sleep in the following morning for up to three nights.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start9 Feb 2023
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants receive same amount of TES stimulations, but in randomized order (stimulation either on the second night or the last night).
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
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
- NCT05970276
- Sponsor's protocol ID
- HSHEALTHY
- Status last verified
- Jul 2023
- First submitted
- 14 Jul 2023
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive At-Home Sleep Therapy System
- ClinicalTrials.gov ID
- NCT05970276
- Acronym / sponsor ID
- HSHEALTHY
- Conditions
- Sleep, Sleep Duration, Sleep Quality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Brain Electrophysiology Laboratory CompanyIndustry (pharma, biotech, devices)
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 1 Aug 2023 (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 goal of this clinical trial is to learn about the ability of non-invasive brain stimulation during sleep to enhance people's deep sleep and its potential benefit on memory in healthy adults via home use sleep therapy device (SleepWISP). Participants will be asked to wear non-invasive and painless devices that record their brain activity during sleep. The clinical trial aims to answer the following main questions:
- Whether the non-invasive transcranial electrical stimulation (TES) delivered by SleepWISP could provide short-term enhancement of deep sleep in a single night in the target population.
- Whether TES delivered by SleepWISP could improve sleep quality.
Detailed description
The purpose of the present research is to evaluate the ability of non-invasive transcranial electrical stimulation (TES) during slow-wave sleep (SWS) to enhance this stage of sleep. It has been demonstrated, in a pilot study, that TES can acutely (i.e., immediately after TES) increase SWS duration. In the present proposal, the study aim to replicate and extend the pilot findings. More specifically, it is proposed to conduct a sleep study using the Brain Electrophysiology Laboratory (BEL) company's Sleep WISP device (described in detail below). The Sleep WISP device is made up of three components: 1) 16-channel EEG amplifier with transcranial electrical stimulation (TES) capabilities, 2) a 16-channel EEG headband and 3) a small portable computer.
All participants will be provided a Sleep WISP device. Participation in the study requires that participants use the Sleep WISP when they sleep. As participants sleep, their sleep EEG will be measured and automatically scored by the computer to determine stage of sleep. When SWS is detected, low-level current (.5-1 mA total) will be applied through pre-set electrodes (four on the forehead and four at base of back of head). These electrodes were used in our pilot study, showing that current applied through these electrodes during SWS is able to increase total SWS sleep duration.
The study involves up to three nights of sleep. All sleep session will be at home. The first session is a baseline/acclimation session. In the first session, participants will use the Sleep WISP device to passively record sleep EEG (no TES) as baseline. The second session is performed the night following the baseline session with randomized experiment condition (either placebo or active TES session). Participants will be blinded for what condition they receive. The final session will occur one week after the second session to receive the opposite experiment condition to the second session.
In our previous TES study of SWS enhancement in the BEL lab, the investigators were able to show that SWS can be enhanced immediately (short-term/acute) after TES. The proposed new study will extend the previous pilot in-lab study results by using Sleep WISP device at home, which will allow us to support home EEG sleep monitoring and acute sleep therapy.
Aim 1: The study aims to replicate our previous in-lab study (acute/short-term enhancement of SWS) with Sleep WISP device at home for deep sleep enhance.
Aim 2: The study aims to investigate any change on sleep quality associated with TES sleep therapy delivered by Sleep WISP device.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants receive same amount of TES stimulations, but in randomized order (stimulation either on the second night or the last night).
| Arm | Type | Receives |
|---|---|---|
| Deep Sleep Enhancement with TES | Experimental | Device: Deep Sleep (N3) Enhancement with TESTranscranial Electrical Stimulation, 0.5 Hz sine wave, 0.5 mA, between frontal (frontopolar and inferior lateral frontal) and posterior (mastoid and occipital) electrodes. |
Who may qualify
- Ages
- 22 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Normally aging adults between the ages of 22-85
Key exclusion criteria (15 listed)
- History of seizures
- History of epilepsy
- History of brain injury or trauma (including neurosurgery)
- History or presence of significant neurological disease such as Parkinson
- History of Electroconvulsive Therapy (ECT)
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 |
|---|---|---|
| Deep Sleep (N3) Enhancement with TESAlso: SleepWISP TESAs participants sleep, their sleep EEG will be measured and automatically scored by the computer to determine stage of sleep. When slow wave sleep is detected, low-level current (.5-1 mA total) will be applied through pre-set electrodes. | Device | Deep Sleep Enhancement with TES |
Primary outcome
Nocturnal duration of deep sleep assessed in minutes
Time frame: Measured during the nights of sleep (typically 8 hours) for up to three nights.
Duration in minutes of N3 sleep
1 secondary outcome
Nocturnal sleep quality assessed by Pittsburgh Sleep Quality Index (PSQI)
Time frame: Measured after each night of sleep in the following morning for up to three nights.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Sleep (N3) Enhancement with TES in people with Sleep and Sleep Duration, 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 15 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: status not confirmed, as of the sponsor's last update on 2 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Don M Tucker, PhD (541-653-8266, don.tucker@bel.company), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nocturnal duration of deep sleep assessed in minutes (time frame: Measured during the nights of sleep (typically 8 hours) for up to three nights.). 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 2 Aug 2023.