Evaluation of a Neurostimulation Device for Insomnia: A Randomized Trial

NCT ID: NCT04627480

Last Updated: 2021-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2021-02-21

Brief Summary

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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

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Conditions

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Insomnia Insomnia Chronic Sleep

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Sham Device

Study Groups

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Experiment Arm

Active Fisher Wallace device for full 8 weeks

Group Type EXPERIMENTAL

Fisher Wallace Neurostimulation Device

Intervention Type DEVICE

a Cranial Electrotherapy Stimulator Device (CES).

Sham Arm

Sham Fisher Wallace device for 4 weeks, then cross over at 4 weeks to active device.

Group Type SHAM_COMPARATOR

Fisher Wallace Neurostimulation Device

Intervention Type DEVICE

a Cranial Electrotherapy Stimulator Device (CES).

Interventions

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Fisher Wallace Neurostimulation Device

a Cranial Electrotherapy Stimulator Device (CES).

Intervention Type DEVICE

Eligibility Criteria

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Exclusion Criteria

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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fisher Wallace

UNKNOWN

Sponsor Role collaborator

ProofPilot

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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ProofPilot (Remote Virtual Trial)

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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2513

Identifier Type: -

Identifier Source: org_study_id

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