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

Primary Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00520832
• Other study ID #: SR0524070091
• Status: Completed
• Phase: Phase 2
• First received: August 23, 2007
• Last updated: October 16, 2008
• Start date: September 2007
• Est. completion date: December 2007

Study information

• Verified date: October 2008
• Source: Logan College of Chiropractic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Primary Insomnia

Intervention

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

Locations

Country	Name	City	State
United States	Logan College of Chiropractic	Chesterfield	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Logan College of Chiropractic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pittsburgh Sleep Quality Index (PSQI)
Primary	Epworth Sleepiness Scale
Primary	Insomnia Severity Index