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

Sponsored by:	Logan College of Chiropractic
Information provided by:	Logan College of Chiropractic
ClinicalTrials.gov Identifier:	NCT00520832

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 II

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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
MC-E: Experimental 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.
MC-P: Placebo Comparator 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

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

Keywords provided by Logan College of Chiropractic:

Primary Insomnia
Microcurrent Therapy
Sleep Surveys

Study placed in the following topic categories:

Sleep Initiation and Maintenance Disorders
Mental Disorders
Dyssomnias
Sleep Disorders
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders
Mental Disorders
Nervous System Diseases

Sleep Disorders
Dyssomnias
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on July 06, 2009