Evaluation of a Neurostimulation Device for Insomnia: A Randomized Trial

Insomnia Clinical Trial

Official title:

Evaluation of a Neurostimulation Device for Insomnia: A Randomized Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04627480
• Other study ID #: 2513
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: October 1, 2020
• Est. completion date: February 21, 2021

Study information

• Verified date: November 2020
• Source: ProofPilot
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: February 21, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Insomnia Chronic
• Sleep
• Sleep Initiation and Maintenance Disorders

Intervention

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

Locations

Country	Name	City	State
United States	ProofPilot (Remote Virtual Trial)	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
ProofPilot	Fisher Wallace

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Device Tolerance and Safety measured by SAFTEE	assessment of safety and adverse events	4 weeks from baseline
Secondary	Change in WASO (wake after sleep onset) between sham versus active arms	measured by Fitbit Charge 4 connected health device worn on the wrist	baseline versus week 4
Secondary	Change in Insomnia Severity between Sham versus active arms	measured by the self report Insomnia Severity Index (ISI)	baseline versus week 4