NCT01674179

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
560

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2010

Completed
2 years until next milestone

First Posted

Study publicly available on registry

August 28, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

October 13, 2016

Status Verified

October 1, 2016

Enrollment Period

2.3 years

First QC Date

September 10, 2010

Last Update Submit

October 12, 2016

Conditions

Fibromyalgia

Keywords

FibromyalgiaqEEGSleepPain

Outcome Measures

Primary Outcomes (1)

  • 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

    up to 24 weeks

Study Arms (2)

ACR diagnosis of Fibromyalgia

Patients without Fibromyalgia

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Private Sleep Practice

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SouthCoast Medical Group

Savannah, Georgia, 31406, United States

Location

Related Publications (1)

  • 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: 25233248DERIVED

MeSH Terms

Conditions

FibromyalgiaPain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Victor Rosenfeld, MD

    SouthCoast Medical Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 10, 2010

First Posted

August 28, 2012

Study Start

July 1, 2010

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

October 13, 2016

Record last verified: 2016-10

Locations

US(1)