Evaluation of a Neurostimulation Device for Insomnia: A Randomized Trial

Sponsor
ProofPilot (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04627480
Collaborator
Fisher Wallace (Other)
200
1
2
4.7
42.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Fisher Wallace Neurostimulation Device
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Masking Description:
Sham Device
Primary Purpose:
Treatment
Official Title:
Evaluation of a Neurostimulation Device for Insomnia: A Randomized Trial
Actual Study Start Date :
Oct 1, 2020
Anticipated Primary Completion Date :
Jan 31, 2021
Anticipated Study Completion Date :
Feb 21, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experiment Arm

Active Fisher Wallace device for full 8 weeks

Device: Fisher Wallace Neurostimulation Device
a Cranial Electrotherapy Stimulator Device (CES).

Sham Comparator: Sham Arm

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

Device: Fisher Wallace Neurostimulation Device
a Cranial Electrotherapy Stimulator Device (CES).

Outcome Measures

Primary Outcome Measures

  1. Change in total sleep per night at week 4 between active and sham arm [baseline versus week 4]

    Measured by Fitbit Charge 4 connected health device work on the wrist

Secondary Outcome Measures

  1. Device Tolerance and Safety measured by SAFTEE [4 weeks from baseline]

    assessment of safety and adverse events

  2. Change in WASO (wake after sleep onset) between sham versus active arms [baseline versus week 4]

    measured by Fitbit Charge 4 connected health device worn on the wrist

  3. Change in Insomnia Severity between Sham versus active arms [baseline versus week 4]

    measured by the self report Insomnia Severity Index (ISI)

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 ProofPilot (Remote Virtual Trial) New York New York United States 10003

Sponsors and Collaborators

  • ProofPilot
  • Fisher Wallace

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ProofPilot
ClinicalTrials.gov Identifier:
NCT04627480
Other Study ID Numbers:
  • 2513
First Posted:
Nov 13, 2020
Last Update Posted:
Jan 14, 2021
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 14, 2021