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OpenTrials
Active, Not Recruiting

NCT Number: NCT04627480

Evaluation of a Neurostimulation Device for Insomnia: A Randomized Trial

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Insomnia Dyssomnias Insomnia Chronic Mental Disorders Nervous System Diseases Sleep Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

ProofPilot (Remote Virtual Trial)

New York, 10003, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fisher Wallace Neurostimulation Device

Device

a Cranial Electrotherapy Stimulator Device (CES).

Primary outcomes

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

    Time frame: baseline versus week 4

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

Secondary outcomes

  1. Device Tolerance and Safety measured by SAFTEE

    Time frame: 4 weeks from baseline

    assessment of safety and adverse events

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

    Time frame: 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

    Time frame: baseline versus week 4

    measured by the self report Insomnia Severity Index (ISI)

Sponsors and collaborators

Lead sponsor

ProofPilot

Industry

Collaborators

  • Fisher Wallace

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 13, 2020
Registry last updated
Jan 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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