A Pilot Study Of The Effects Of Microcurrent On Three Sleep Surveys - Tabular View

Tracking Information

First Received Date ^ICMJE

August 23, 2007

Last Updated Date

October 16, 2008

Start Date ^ICMJE

September 2007

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00520832 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Primary Insomnia

Intervention ^ICMJE

Device: Microcurrent

Study Arms / Comparison Groups

Experimental: 20 minutes of sub-threshold microcurrent 2 hours before bedtime per day for 21 days.
Placebo Comparator: Participants will receive a device identical to the active device used in the experimental condition, but which produces no current.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

December 2007

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 40 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00520832

Responsible Party

Study ID Numbers ^ICMJE

SR0524070091

Study Sponsor ^ICMJE

Logan College of Chiropractic

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Rodger Tepe, PhD

Logan College of Chiropractic

Information Provided By

Logan College of Chiropractic

Verification Date

October 2008

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