NCT00520832

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 27, 2007

Completed
5 days until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

October 17, 2008

Status Verified

October 1, 2008

Enrollment Period

3 months

First QC Date

August 23, 2007

Last Update Submit

October 16, 2008

Conditions

Primary Insomnia

Keywords

Primary InsomniaMicrocurrent TherapySleep Surveys

Outcome Measures

Primary Outcomes (3)

  • Pittsburgh Sleep Quality Index (PSQI)

  • Epworth Sleepiness Scale

  • Insomnia Severity Index

Study Arms (2)

MC-E

EXPERIMENTAL

20 minutes of sub-threshold microcurrent 2 hours before bedtime per day for 21 days.

Device: Microcurrent

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

Interventions

MicrocurrentDEVICE

20 minutes of sub-threshold microcurrent 2 hours before bedtime per day for 21 days.

MC-E

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Student, Faculty or Staff
  • Age 18 - 40
  • Symptoms of primary insomnia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Logan College of Chiropractic

Chesterfield, Missouri, 63017, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Rodger Tepe, PhD

    Logan College of Chiropractic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 23, 2007

First Posted

August 27, 2007

Study Start

September 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

October 17, 2008

Record last verified: 2008-10

Locations

US(1)