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

October 16, 2008 updated by: Logan College of Chiropractic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Logan College of Chiropractic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MC-E
20 minutes of sub-threshold microcurrent 2 hours before bedtime per day for 21 days.
Device: Microcurrent
20 minutes of sub-threshold microcurrent 2 hours before bedtime per day for 21 days.
Device: Microcurrent
Participants will receive a device identical to the active device used in the experimental condition, but which produces no current.
Placebo Comparator: MC-P
Participants will receive a device identical to the active device used in the experimental condition, but which produces no current.
Device: Microcurrent
20 minutes of sub-threshold microcurrent 2 hours before bedtime per day for 21 days.
Device: Microcurrent
Participants will receive a device identical to the active device used in the experimental condition, but which produces no current.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pittsburgh Sleep Quality Index (PSQI)
Epworth Sleepiness Scale
Insomnia Severity Index

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Logan College of Chiropractic

Investigators

  • Principal Investigator: Rodger Tepe, PhD, Logan College of Chiropractic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

August 23, 2007

First Submitted That Met QC Criteria

August 23, 2007

First Posted (Estimate)

August 27, 2007

Study Record Updates

Last Update Posted (Estimate)

October 17, 2008

Last Update Submitted That Met QC Criteria

October 16, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SR0524070091

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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