FibromyalgiaFMQEEG-10-26NCT01674179
Quantitative EEG During PSG in Patients With and Without Fibromyalgia
An observational study of Fibromyalgia, run by SouthCoast Medical Group at 1 site in United States.
Trial summary
The purpose of this study is to retrospectively analyze Clinical and Nocturnal Polysomnographic Data (Overnight Sleep Studies) in patients with and without Fibromyalgia. Fibromyalgia is a pain syndrome associated with dysfunctional sleep, fatigue, frequent awakenings, non-refreshing sleep, and alpha frequency… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fibromyalgia
- How many people
- 560 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Oct 2012
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Private Sleep Practice
Who may be able to join
- Completed a polysomnogram
- Complaints of disordered sleep
- Age 18 to 80 inclusive
- Men and women
Who cannot join
- History of seizure
- use of benzodiazepines
- use of AEDs
- any significant medical condition other than disorder sleep or fibromyalgia that would influence qEEG measures
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to retrospectively analyze Clinical and Nocturnal Polysomnographic Data (Overnight Sleep Studies) in patients with and without Fibromyalgia.
Fibromyalgia is a pain syndrome associated with dysfunctional sleep, fatigue, frequent awakenings, non-refreshing sleep, and alpha frequency intrusions. Quantitative EEG during routine Nocturnal Polysomnography can be used to assess Alpha/Delta sleep. Hypothesis: Alpha intrusions may be an objective marker for Fibromyalgia and may correlate with current clinical American College of Rheumatology Criteria for the diagnosis of Fibromyalgia.
Read the detailed description
This is a Retrospective Study of patients with and without Fibromyalgia seen in private practice from Aug 2007-July 2010 who underwent Overnight Sleep Studies (PSG)
The polysomnographic and clinical data from research subjects with a diagnosis of Fibromyalgia will be compared to other subjects' PSG and Clinical data who were also referred for Sleep Studies including those with Sleep Apnea, Narcolepsy, Periodic Limb Movement, Fatigue, and Insomnia which are standard indications for Overnight Sleep Studies.
Clinical Data: Clinical Data points will include the following: 1. Research Study Number, 2. Age, 3. Gender, 4. Body Mass Index, 5. Epworth Sleepiness Scale (self reported scale on Sleepiness), 6. Fatigue Severity Scale (self reported scale on Fatigue, 7. American College of Rheumatology (ACR) Criteria for Fibromyalgia, 8. Manual Tender Point Exam (# of anatomically specific tender points/18), 9. Medications: Benzodiazepines (Bnz, Bnz ), Tricyclic Antidepressants (TCA) and Serotonin Reuptake Inhibitors (SSRIs SNRIs).
Sleep Study Data Points: The following data points will be captured from Overnight Sleep Studies: 1. Total Sleep Time, 2. Sleep Efficiency, 3. Wake After Sleep Onset, 4.Apnea/Hypopnea Index, 5. Respiratory Distress Index, 6. Periodic Limb Movement Index, 7. Periodic Limb Movement Arousal Index, and 8. Quantitative EEG: Delta Event/Alpha Event Ratio.
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, qEEG, Sleep, Pain
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ACR diagnosis of Fibromyalgia | Not described | |
| Patients without Fibromyalgia | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delta Event/Alpha Event Ratios in Non-REM sleep
Assess the sensitivity and specificity of Delta Event/Alpha Event Ratios in Non-REM sleep in patients with and without Fibromyalgia
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2012 (estimated)
- Study startJul 2010
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 560 participants (actual)
Sponsor and investigators
- Lead sponsor
- SouthCoast Medical Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victor Rosenfeld MD, SouthCoast Medical Group
- Investigators
- Victor Rosenfeld, MD, Principal investigator, SouthCoast Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01674179
- Sponsor's protocol ID
- SM 10-26
- Acronym
- FMQEEG-10-26
- Status last verified
- Oct 2016
- First submitted
- 10 Sep 2010
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Rosenfeld VW, Rutledge DN, Stern JM. Polysomnography with quantitative EEG in patients with and without fibromyalgia. J Clin Neurophysiol. 2015 Apr;32(2):164-70. doi: 10.1097/WNP.0000000000000134.
PubMed 25233248
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative EEG During PSG in Patients With and Without Fibromyalgia
- ClinicalTrials.gov ID
- NCT01674179
- Acronym / sponsor ID
- FMQEEG-10-26 / SM 10-26
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, qEEG, Sleep, Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 560 participants (actual)
- Lead sponsor
- SouthCoast Medical GroupUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 28 Aug 2012 (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.
The purpose of this study is to retrospectively analyze Clinical and Nocturnal Polysomnographic Data (Overnight Sleep Studies) in patients with and without Fibromyalgia.
Fibromyalgia is a pain syndrome associated with dysfunctional sleep, fatigue, frequent awakenings, non-refreshing sleep, and alpha frequency intrusions. Quantitative EEG during routine Nocturnal Polysomnography can be used to assess Alpha/Delta sleep. Hypothesis: Alpha intrusions may be an objective marker for Fibromyalgia and may correlate with current clinical American College of Rheumatology Criteria for the diagnosis of Fibromyalgia.
Detailed description
This is a Retrospective Study of patients with and without Fibromyalgia seen in private practice from Aug 2007-July 2010 who underwent Overnight Sleep Studies (PSG)
The polysomnographic and clinical data from research subjects with a diagnosis of Fibromyalgia will be compared to other subjects' PSG and Clinical data who were also referred for Sleep Studies including those with Sleep Apnea, Narcolepsy, Periodic Limb Movement, Fatigue, and Insomnia which are standard indications for Overnight Sleep Studies.
Clinical Data: Clinical Data points will include the following: 1. Research Study Number, 2. Age, 3. Gender, 4. Body Mass Index, 5. Epworth Sleepiness Scale (self reported scale on Sleepiness), 6. Fatigue Severity Scale (self reported scale on Fatigue, 7. American College of Rheumatology (ACR) Criteria for Fibromyalgia, 8. Manual Tender Point Exam (# of anatomically specific tender points/18), 9. Medications: Benzodiazepines (Bnz, Bnz ), Tricyclic Antidepressants (TCA) and Serotonin Reuptake Inhibitors (SSRIs SNRIs).
Sleep Study Data Points: The following data points will be captured from Overnight Sleep Studies: 1. Total Sleep Time, 2. Sleep Efficiency, 3. Wake After Sleep Onset, 4.Apnea/Hypopnea Index, 5. Respiratory Distress Index, 6. Periodic Limb Movement Index, 7. Periodic Limb Movement Arousal Index, and 8. Quantitative EEG: Delta Event/Alpha Event Ratio.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACR diagnosis of Fibromyalgia | – | – |
| Patients without Fibromyalgia | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Private Sleep Practice
Key inclusion criteria (4 listed)
- Completed a polysomnogram
- Complaints of disordered sleep
- Age 18 to 80 inclusive
- Men and women
Key exclusion criteria (4 listed)
- History of seizure
- use of benzodiazepines
- use of AEDs
- any significant medical condition other than disorder sleep or fibromyalgia that would influence qEEG measures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Delta Event/Alpha Event Ratios in Non-REM sleep
Time frame: up to 24 weeks
Assess the sensitivity and specificity of Delta Event/Alpha Event Ratios in Non-REM sleep in patients with and without Fibromyalgia
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 13 Oct 2016.
- Derived from this study: PubMed 25233248Rosenfeld VW, Rutledge DN, Stern JM. Polysomnography with quantitative EEG in patients with and without fibromyalgia. J Clin Neurophysiol. 2015 Apr;32(2):164-70. doi: 10.1097/WNP.0000000000000134.
Related trials for Fibromyalgia
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
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.
Victor Rosenfeld, MD principal investigator
SouthCoast Medical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, run by SouthCoast Medical Group 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 4 inclusion and 4 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 13 Oct 2016. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Delta Event/Alpha Event Ratios in Non-REM sleep (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01674179, which also lists 1 linked publication.
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 13 Oct 2016.