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Evaluation of a Neurostimulation Device for Insomnia: A Randomized Trial

NCT04627480 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-01-14

No results posted yet for this 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.

Conditions

Interventions

DEVICE

Fisher Wallace Neurostimulation Device

a Cranial Electrotherapy Stimulator Device (CES).

Sponsors & Collaborators

  • Fisher Wallace

    collaborator UNKNOWN

  • ProofPilot

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2021-01-31
Completion
2021-02-21
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04627480 on ClinicalTrials.gov