Evaluation of a Neurostimulation Device for Insomnia: A Randomized Trial

NCT04627480 | Active Not Recruiting Phase 4 FDA Device

• 1 other identifier: 2513
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia; Insomnia Chronic; Sleep

Outcome Measures

Primary Outcomes (1)

• 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

  baseline versus week 4

Secondary Outcomes (3)

• Device Tolerance and Safety measured by SAFTEE

  4 weeks from baseline

• Change in WASO (wake after sleep onset) between sham versus active arms

  baseline versus week 4

• Change in Insomnia Severity between Sham versus active arms

  baseline versus week 4

Study Arms (2)

Experiment Arm

EXPERIMENTAL

Active Fisher Wallace device for full 8 weeks

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.

Device: Fisher Wallace Neurostimulation Device

Interventions

Fisher Wallace Neurostimulation Device DEVICE

a Cranial Electrotherapy Stimulator Device (CES).

Experiment Arm; Sham Arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• ProofPilot: lead
• Fisher Wallace: collaborator

Study Sites (1)

ProofPilot (Remote Virtual Trial)

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Sham Device
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: November 13, 2020
• Study Start: October 1, 2020
• Primary Completion: January 31, 2021
• Study Completion: February 21, 2021
• Last Updated: January 14, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)