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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
History of Changes

August 23, 2007
October 16, 2008
September 2007
December 2007   (final data collection date for primary outcome measure)
  • Pittsburgh Sleep Quality Index (PSQI)
  • Epworth Sleepiness Scale
  • Insomnia Severity Index
Same as current
Complete list of historical versions of study NCT00520832 on ClinicalTrials.gov Archive Site
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A Pilot Study Of The Effects Of Microcurrent On Three Sleep Surveys
A Pilot Study Of The Effects Of Microcurrent On Three Sleep Surveys

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Insomnia
  • 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.
  • Experimental: MC-E
    20 minutes of sub-threshold microcurrent 2 hours before bedtime per day for 21 days.
    Intervention: Device: Microcurrent
  • Placebo Comparator: MC-P
    Participants will receive a device identical to the active device used in the experimental condition, but which produces no current.
    Intervention: Device: Microcurrent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2007
December 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00520832
SR0524070091
Not Provided
Not Provided
Logan College of Chiropractic
Not Provided
Principal Investigator: Rodger Tepe, PhD Logan College of Chiropractic
Logan College of Chiropractic
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP