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Neurostimulation Device

Experiment Arm for Insomnia

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

Study 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
  • Insomnia
  • Chronic Insomnia
  • Sleep

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in total sleep per night at week 4 between active and sham arm
Secondary outcome measures
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

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
1,506 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Evaluation of a Neurostimulation Device for Insomnia: A Randomized Trial
2020. "Evaluation of a Neurostimulation Device for Insomnia: A Randomized Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04627480.
All > Insomnia
~44 spots leftby Apr 2025
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