InsomniaPhase 4NCT04627480
Evaluation of a Neurostimulation Device for Insomnia: A Randomized Trial
A Phase 4 study testing Fisher Wallace Neurostimulation Device in people with Insomnia and Insomnia Chronic, run by ProofPilot at 1 site in United States.
Trial summary
Examine the safety and effectiveness of the Fisher Wallace Cranial Electrotherapy Stimulator Device (CES) for the treatment of insomnia characterized by difficulties with sleep maintenance using a 20-minute treatment right before bedtime. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Insomnia, Insomnia Chronic, Sleep
- What is being tested?
- Fisher Wallace Neurostimulation Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 21 Feb 2021
- Phase
- Phase 4
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Age greater than or equal to 21 US resident Can receive packages to their home via UPS/Fedex/USPS Read/write English Insomnia Severity Index Score Greater than 14 Diagnosis of insomnia by a medical physician Subjects with a Generalized Anxiety Diagnosis will be excluded Have not contemplated suicide in the past year Not been institutionalized for mental health issues. Not currently being treated for or suspect a mental health issue Not currently experiencing problems with alcohol or drug abuse Can commit to not drinking alcohol 4 hours before bedtime for the duration of the study Not taking medications affecting the nervous system (e.g. psychiatric medications) Not taking hypnotics or any sleep aid or marijuana (in any form) Can commit to one (1) 20 minute session per day for 8 weeks Has not used a brain stimulation treatment in one year No suspected or known history of heart disease No pacemaker, or any form of medical electronics, including but not limited to a deep brain stimulator, electronic stent, etc.
Not under medical supervision for other serious medical condition Not taking opioids No pain or headaches that interrupt sleep Not participating in any other sleep study Not experiencing restless leg syndrome No Nickel Allergy No Sleep Apena as measured by STOP-Bang Assessment
Trial locations and contacts
1 site in 1 country.
United States1 site
ProofPilot (Remote Virtual Trial)
New York, New York, 10003
About this study
Examine the safety and effectiveness of the Fisher Wallace Cranial Electrotherapy Stimulator Device (CES) for the treatment of insomnia characterized by difficulties with sleep maintenance using a 20-minute treatment right before bedtime.
- Conditions
- Insomnia, Insomnia Chronic, Sleep
- Being tested
- Fisher Wallace Neurostimulation Device
- 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.
Fisher Wallace Neurostimulation DeviceDevice
a Cranial Electrotherapy Stimulator Device (CES).
| Study group | Role | What they receive |
|---|---|---|
| Experiment Arm | Experimental | Active Fisher Wallace device for full 8 weeks Receives: Device: Fisher Wallace Neurostimulation Device |
| Sham Arm | Sham comparator | Sham Fisher Wallace device for 4 weeks, then cross over at 4 weeks to active device. Receives: Device: Fisher Wallace Neurostimulation Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total sleep per night at week 4 between active and sham arm
Measured by Fitbit Charge 4 connected health device work on the wrist
Measured: baseline versus week 4
Secondary outcomes (3)
Device Tolerance and Safety measured by SAFTEE
assessment of safety and adverse events
Measured: 4 weeks from baseline
Change in WASO (wake after sleep onset) between sham versus active arms
measured by Fitbit Charge 4 connected health device worn on the wrist
Measured: baseline versus week 4
Change in Insomnia Severity between Sham versus active arms
measured by the self report Insomnia Severity Index (ISI)
Measured: baseline versus week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start1 Oct 2020
- Primary completion31 Jan 2021 (estimated)
- Study completion21 Feb 2021 (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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ProofPilot
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fisher Wallace
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04627480
- Sponsor's protocol ID
- 2513
- Status last verified
- Nov 2020
- First submitted
- 9 Nov 2020
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Neurostimulation Device for Insomnia: A Randomized Trial
- ClinicalTrials.gov ID
- NCT04627480
- Acronym / sponsor ID
- 2513
- Conditions
- Insomnia, Insomnia Chronic, Sleep
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- ProofPilotIndustry (pharma, biotech, devices)
- Collaborators
- Fisher Wallace
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Jan 2021 (estimated)
- Study completion
- 21 Feb 2021 (estimated)
- First posted
- 13 Nov 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.
Examine the safety and effectiveness of the Fisher Wallace Cranial Electrotherapy Stimulator Device (CES) for the treatment of insomnia characterized by difficulties with sleep maintenance using a 20-minute treatment right before bedtime.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experiment Arm | Experimental | Device: Fisher Wallace Neurostimulation DeviceActive Fisher Wallace device for full 8 weeks |
| Sham Arm | Sham comparator | Device: Fisher Wallace Neurostimulation DeviceSham Fisher Wallace device for 4 weeks, then cross over at 4 weeks to active device. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Fisher Wallace Neurostimulation Devicea Cranial Electrotherapy Stimulator Device (CES). | Device | Experiment Arm, Sham Arm |
Primary outcome
Change in total sleep per night at week 4 between active and sham arm
Time frame: baseline versus week 4
Measured by Fitbit Charge 4 connected health device work on the wrist
3 secondary outcomes
Device Tolerance and Safety measured by SAFTEE
Time frame: 4 weeks from baseline
Change in WASO (wake after sleep onset) between sham versus active arms
Time frame: baseline versus week 4
Change in Insomnia Severity between Sham versus active arms
Time frame: baseline versus week 4
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 14 Jan 2021.
- 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.
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 Phase 4 study testing Fisher Wallace Neurostimulation Device in people with Insomnia and Insomnia Chronic, run by ProofPilot 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?
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 14 Jan 2021. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in total sleep per night at week 4 between active and sham arm (time frame: baseline versus week 4). 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 14 Jan 2021.