Fibromyalgia Clinical Trial
Official title:
Quantitative EEG During PSG in Patients With and Without Fibromyalgia
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.
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.
;
Observational Model: Case Control, Time Perspective: Retrospective
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