Insomnia, Insomnia Chronic, Sleep
Conditions
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.
Interventions
DEVICEFisher Wallace Neurostimulation Device
a Cranial Electrotherapy Stimulator Device (CES).
Sponsors
Fisher Wallace
ProofPilot
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Sham Device
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Outcome results
None listed