A Pilot Study Of The Effects Of Microcurrent On Three Sle... | NCT00520832

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

NCT00520832

Sponsor

Logan College of Chiropractic

Status

Completed

Last Update Posted

Oct 17, 2008Estimated

Enrollment

20Estimated

Phase

Phase 2

Conditions

Primary Insomnia

Interventions

Microcurrent
Microcurrent

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Aug 23, 2007

First Submission Date that Met QC Criteria

Aug 23, 2007

First Posted Date

Aug 27, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 16, 2008

Last Update Posted Date

Oct 17, 2008Estimated

Description Module

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Microcurrent	Device	20 minutes of sub-threshold microcurrent 2 hours before bedtime per day for 21 days.	MC-E

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pittsburgh Sleep Quality Index (PSQI)
Epworth Sleepiness Scale
Insomnia Severity Index

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rodger Tepe, PhD	Logan College of Chiropractic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Logan College of Chiropractic		Chesterfield	Missouri	63017	United States

Condition Browse Module

MeSH Terms

ID	Term
D007319	Sleep Initiation and Maintenance Disorders

Ancestor Terms

ID	Term
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided