Primary InsomniaPhase 2NCT00520832
A Pilot Study Of The Effects Of Microcurrent On Three Sleep Surveys
A Phase 2 study testing Microcurrent in people with Primary Insomnia, run by Logan College of Chiropractic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Primary Insomnia
- What is being tested?
- Microcurrent
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Dec 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Student, Faculty or Staff
- Age 18 - 40
- Symptoms of primary insomnia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Logan College of Chiropractic
Chesterfield, Missouri, 63017
About this study
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.
- Conditions
- Primary Insomnia
- Being tested
- Microcurrent
- Keywords
- Primary Insomnia, Microcurrent Therapy, Sleep Surveys
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicrocurrentDevice
20 minutes of sub-threshold microcurrent 2 hours before bedtime per day for 21 days.
MicrocurrentDevice
Participants will receive a device identical to the active device used in the experimental condition, but which produces no current.
| Study group | Role | What they receive |
|---|---|---|
| MC-E | Experimental | 20 minutes of sub-threshold microcurrent 2 hours before bedtime per day for 21 days. Receives: 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. Receives: Device: Microcurrent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index (PSQI)
Epworth Sleepiness Scale
Insomnia Severity Index
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2007 (estimated)
- Study startSep 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Logan College of Chiropractic
- Sponsor type
- University, hospital or other
- Investigators
- Rodger Tepe, PhD, Principal investigator, Logan College of Chiropractic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00520832
- Sponsor's protocol ID
- SR0524070091
- Status last verified
- Oct 2008
- First submitted
- 23 Aug 2007
- Last updated
- 17 Oct 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Of The Effects Of Microcurrent On Three Sleep Surveys
- ClinicalTrials.gov ID
- NCT00520832
- Acronym / sponsor ID
- SR0524070091
- Conditions
- Primary Insomnia
- Keywords
- Primary Insomnia, Microcurrent Therapy, Sleep Surveys
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Logan College of ChiropracticUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 27 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MC-E | Experimental | Device: Microcurrent20 minutes of sub-threshold microcurrent 2 hours before bedtime per day for 21 days. |
| MC-P | Placebo comparator | Device: MicrocurrentParticipants will receive a device identical to the active device used in the experimental condition, but which produces no current. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Student, Faculty or Staff
- Age 18 - 40
- Symptoms of primary insomnia
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microcurrent20 minutes of sub-threshold microcurrent 2 hours before bedtime per day for 21 days. | Device | MC-E |
| MicrocurrentParticipants will receive a device identical to the active device used in the experimental condition, but which produces no current. | Device | MC-P |
Primary outcome
Pittsburgh Sleep Quality Index (PSQI)
Epworth Sleepiness Scale
Insomnia Severity Index
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodger Tepe, PhD principal investigator
Logan College of Chiropractic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Microcurrent in people with Primary Insomnia, run by Logan College of Chiropractic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index (PSQI). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2008.