## Protocol Section
### Identification Module
**NCT ID:** NCT01674179

**Acronym:** FMQEEG-10-26

**Brief Title:** Quantitative EEG During PSG in Patients With and Without Fibromyalgia

**Official Title:** Quantitative EEG During PSG in Patients With and Without Fibromyalgia

#### Organization Study ID Info
**ID:** SM 10-26
#### Organization
**Class:** OTHER
**Full Name:** SouthCoast Medical Group
### Status Module
#### Completion Date
**Date:** 2012-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-10-13

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-10-12

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2012-10

**Type:** ACTUAL

#### Start Date
**Date:** 2010-07

**Status Verified Date:** 2016-10

#### Study First Post Date
**Date:** 2012-08-28
**Type:** ESTIMATED
**Study First Submit Date:** 2010-09-10
**Study First Submit QC Date:** 2012-08-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** SouthCoast Medical Group

#### Responsible Party

**Investigator Affiliation:** SouthCoast Medical Group

**Investigator Full Name:** Victor Rosenfeld MD

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Fibromyalgia

**Keywords:**

- Fibromyalgia

- qEEG

- Sleep

- Pain

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 560

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Label:** ACR diagnosis of Fibromyalgia

#### Arm Group 2

**Label:** Patients without Fibromyalgia

### Outcomes Module

#### Primary Outcomes

**Description:** Assess the sensitivity and specificity of Delta Event/Alpha Event Ratios in Non-REM sleep in patients with and without Fibromyalgia

**Measure:** Delta Event/Alpha Event Ratios in Non-REM sleep

**Time Frame:** up to 24 weeks

### Eligibility Module

**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

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Private Sleep Practice

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Savannah

**Country:** United States

**Facility:** SouthCoast Medical Group

**State:** Georgia

**Zip:** 31406

#### Overall Officials

**Official 1:**

**Affiliation:** SouthCoast Medical Group

**Name:** Victor Rosenfeld, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** 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.

**PMID:** 25233248

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009135

- Term: Muscular Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000012216

- Term: Rheumatic Diseases

- ID: D000009468

- Term: Neuromuscular Diseases

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

### Condition Browse Module - Browse Leaves

- ID: M8486

- Name: Fibromyalgia

- Relevance: HIGH

- As Found: Fibromyalgia

- ID: M12161

- Name: Myofascial Pain Syndromes

- Relevance: HIGH

- As Found: Fibromyalgia

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M12092

- Name: Muscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15045

- Name: Rheumatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6323

- Name: Collagen Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12411

- Name: Neuromuscular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000005356

- Term: Fibromyalgia

- ID: D000009209

- Term: Myofascial Pain Syndromes

### Misc Info Module

- Version Holder: 2024-05-24
