Evaluation of a Neurostimulation Device for Insomnia: A Randomized Trial
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 |
---|---|---|
|
Phase 4 |
Study Design
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
- 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
- Device Tolerance and Safety measured by SAFTEE [4 weeks from baseline]
assessment of safety and adverse events
- 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
- 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
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.- 2513