Quantitative EEG During PSG in Patients With and Without Fibromyalgia

NCT ID: NCT01674179

Last Updated: 2016-10-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 560 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2012-10-31

Brief 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 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.

Conditions

Fibromyalgia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

ACR diagnosis of Fibromyalgia

No interventions assigned to this group

Patients without Fibromyalgia

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Completed a polysomnogram
• Complaints of disordered sleep
• Age 18 to 80 inclusive
• Men and women

Exclusion Criteria

• History of seizure
• use of benzodiazepines
• use of AEDs
• any significant medical condition other than disorder sleep or fibromyalgia that would influence qEEG measures

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SouthCoast Medical Group

OTHER

Sponsor Role: lead

Responsible Party

Victor Rosenfeld MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Victor Rosenfeld, MD

Role: PRINCIPAL_INVESTIGATOR

SouthCoast Medical Group

Locations

SouthCoast Medical Group

Savannah, Georgia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25233248 (View on PubMed)

Other Identifiers

SM 10-26

Identifier Type: -

Identifier Source: org_study_id