Evaluation of a Neurostimulation Device for Insomnia: A Randomized Trial
Phase 4
Active, not recruiting
- Conditions
- InsomniaSleepInsomnia Chronic
- Interventions
- Device: Fisher Wallace Neurostimulation Device
- Registration Number
- NCT04627480
- Lead Sponsor
- ProofPilot
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Experiment Arm Fisher Wallace Neurostimulation Device Active Fisher Wallace device for full 8 weeks Sham Arm Fisher Wallace Neurostimulation Device Sham Fisher Wallace device for 4 weeks, then cross over at 4 weeks to active device.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Change in Insomnia Severity between Sham versus active arms baseline versus week 4 measured by the self report Insomnia Severity Index (ISI)
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
Trial Locations
- Locations (1)
ProofPilot (Remote Virtual Trial)
🇺🇸New York, New York, United States