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

This study has been completed.
Sponsor:
Information provided by:
Logan College of Chiropractic
ClinicalTrials.gov Identifier:
NCT00520832
First received: August 23, 2007
Last updated: October 16, 2008
Last verified: October 2008
  Purpose

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.


Condition Intervention Phase
Primary Insomnia
Device: Microcurrent
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Pilot Study Of The Effects Of Microcurrent On Three Sleep Surveys

Further study details as provided by Logan College of Chiropractic:

Primary Outcome Measures:
  • Pittsburgh Sleep Quality Index (PSQI)
  • Epworth Sleepiness Scale
  • Insomnia Severity Index

Estimated Enrollment: 20
Study Start Date: September 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
Participants will receive a device identical to the active device used in the experimental condition, but which produces no current.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00520832

Locations
United States, Missouri
Logan College of Chiropractic
Chesterfield, Missouri, United States, 63017
Sponsors and Collaborators
Logan College of Chiropractic
Investigators
Principal Investigator: Rodger Tepe, PhD Logan College of Chiropractic
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00520832     History of Changes
Other Study ID Numbers: SR0524070091
Study First Received: August 23, 2007
Last Updated: October 16, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Logan College of Chiropractic:
Primary Insomnia
Microcurrent Therapy
Sleep Surveys

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014