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Evaluation of a Neurostimulation Device for Insomnia: A Randomized Trial

Primary Purpose

Insomnia, Insomnia Chronic, Sleep

Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Fisher Wallace Neurostimulation Device
Sponsored by
ProofPilot
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • ProofPilot (Remote Virtual Trial)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Experiment Arm

Sham Arm

Arm Description

Active Fisher Wallace device for full 8 weeks

Sham Fisher Wallace device for 4 weeks, then cross over at 4 weeks to active device.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Device Tolerance and Safety measured by SAFTEE
assessment of safety and adverse events
Change in WASO (wake after sleep onset) between sham versus active arms
measured by Fitbit Charge 4 connected health device worn on the wrist
Change in Insomnia Severity between Sham versus active arms
measured by the self report Insomnia Severity Index (ISI)

Full Information

First Posted
November 9, 2020
Last Updated
January 13, 2021
Sponsor
ProofPilot
Collaborators
Fisher Wallace
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1. Study Identification

Unique Protocol Identification Number
NCT04627480
Brief Title
Evaluation of a Neurostimulation Device for Insomnia: A Randomized Trial
Official Title
Evaluation of a Neurostimulation Device for Insomnia: A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
January 31, 2021 (Anticipated)
Study Completion Date
February 21, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ProofPilot
Collaborators
Fisher Wallace

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Insomnia Chronic, Sleep

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Sham Device
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experiment Arm
Arm Type
Experimental
Arm Description
Active Fisher Wallace device for full 8 weeks
Arm Title
Sham Arm
Arm Type
Sham Comparator
Arm Description
Sham Fisher Wallace device for 4 weeks, then cross over at 4 weeks to active device.
Intervention Type
Device
Intervention Name(s)
Fisher Wallace Neurostimulation Device
Intervention Description
a Cranial Electrotherapy Stimulator Device (CES).
Primary Outcome Measure Information:
Title
Change in total sleep per night at week 4 between active and sham arm
Description
Measured by Fitbit Charge 4 connected health device work on the wrist
Time Frame
baseline versus week 4
Secondary Outcome Measure Information:
Title
Device Tolerance and Safety measured by SAFTEE
Description
assessment of safety and adverse events
Time Frame
4 weeks from baseline
Title
Change in WASO (wake after sleep onset) between sham versus active arms
Description
measured by Fitbit Charge 4 connected health device worn on the wrist
Time Frame
baseline versus week 4
Title
Change in Insomnia Severity between Sham versus active arms
Description
measured by the self report Insomnia Severity Index (ISI)
Time Frame
baseline versus week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
ProofPilot (Remote Virtual Trial)
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of a Neurostimulation Device for Insomnia: A Randomized Trial

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