Evaluation of a Neurostimulation Device for Insomnia: A Randomized Trial

Phase 4Active Not RecruitingNCT04627480

ProofPilot200 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

200

Conditions

Insomnia Insomnia Chronic Sleep

Interventions

Fisher Wallace Neurostimulation DeviceDEVICE

a Cranial Electrotherapy Stimulator Device (CES).

Eligibility

Sex: ALLMin age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

ProofPilot (Remote Virtual Trial)

New York, New York, United States

Outcomes

Primary Outcomes

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

Time frame: baseline versus week 4

Secondary Outcomes

Device Tolerance and Safety measured by SAFTEE

assessment of safety and adverse events

Time frame: 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

Time frame: baseline versus week 4

Change in Insomnia Severity between Sham versus active arms

measured by the self report Insomnia Severity Index (ISI)

Time frame: baseline versus week 4

Data from ClinicalTrials.gov

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