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Neurostimulation Device

Evaluation of a Neurostimulation Device for Insomnia: A Randomized Trial

Phase 4
Waitlist Available
Research Sponsored by ProofPilot
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks from baseline
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

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.

Eligible Conditions
  • Sleep
  • Insomnia
  • Chronic insomnia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks from baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks from baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in total sleep per night at week 4 between active and sham arm
Secondary study objectives
Change in Insomnia Severity between Sham versus active arms
Change in WASO (wake after sleep onset) between sham versus active arms
Device Tolerance and Safety measured by SAFTEE

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experiment ArmExperimental Treatment1 Intervention
Active Fisher Wallace device for full 8 weeks
Group II: Sham ArmPlacebo Group1 Intervention
Sham Fisher Wallace device for 4 weeks, then cross over at 4 weeks to active device.

Find a Location

Who is running the clinical trial?

Fisher WallaceUNKNOWN
2 Previous Clinical Trials
325 Total Patients Enrolled
ProofPilotLead Sponsor
11 Previous Clinical Trials
1,446 Total Patients Enrolled
1 Trials studying Sleep
133 Patients Enrolled for Sleep
~39 spots leftby Dec 2025
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