A Pilot Study Of The Effects Of Microcurrent On Three Sleep Surveys

NCT ID: NCT00520832

Last Updated: 2008-10-17

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2007-12-31

Brief Summary

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Participants identified as having primary insomnia will be randomly assigned to groups receiving microcurrent stimulation or sham in a double-blind randomized controlled trial. The microcurrent device used is FDA approved for the treatment of insomnia.

The hypothesis is that the experimental group will have significantly improved scores on three sleep surveys after treatment while the sham group will not.

Detailed Description

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Conditions

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Primary Insomnia

Keywords

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Primary Insomnia Microcurrent Therapy Sleep Surveys

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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MC-E

20 minutes of sub-threshold microcurrent 2 hours before bedtime per day for 21 days.

Group Type EXPERIMENTAL

Microcurrent

Intervention Type DEVICE

20 minutes of sub-threshold microcurrent 2 hours before bedtime per day for 21 days.

MC-P

Participants will receive a device identical to the active device used in the experimental condition, but which produces no current.

Group Type PLACEBO_COMPARATOR

Microcurrent

Intervention Type DEVICE

Participants will receive a device identical to the active device used in the experimental condition, but which produces no current.

Interventions

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Microcurrent

20 minutes of sub-threshold microcurrent 2 hours before bedtime per day for 21 days.

Intervention Type DEVICE

Microcurrent

Participants will receive a device identical to the active device used in the experimental condition, but which produces no current.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Student, Faculty or Staff
* Age 18 - 40
* Symptoms of primary insomnia

Exclusion Criteria

* No implanted electric devices
* No local infection, injury or malignancy
* No history of seizure or other neurological disorders
* No current use of prescription or other substances that could effect sleep quality or quantity
* Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Logan College of Chiropractic

OTHER

Sponsor Role lead

Principal Investigators

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Rodger Tepe, PhD

Role: PRINCIPAL_INVESTIGATOR

Logan College of Chiropractic

Locations

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Logan College of Chiropractic

Chesterfield, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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SR0524070091

Identifier Type: -

Identifier Source: org_study_id