Peripheral Arterial Tonometry (PAT) Evaluation of Sleep in Fibromyalgia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01151163
First received: June 24, 2010
Last updated: February 7, 2011
Last verified: February 2011
  Purpose

Fibromyalgia syndrome (FMS) is characterized by the presence of widespread pain, chronic fatigue and typical sleep disturbances. The purpose of the current study is to investigate the nature of sleep disturbance in FMS, using a novel technology. Peripheral arterial tonometry is a method by which peripheral arterial tone is measured non - invasively using in an ambulatory setup during sleep. The information collected reflects autonomic nervous system function and respiratory changes during sleep. We intend to utilize this technique in order to improve our understanding of the interrupted patterns of sleep in FMS and as a possible biomarker which may be used in the future to follow up FMS patients and their response to treatment.


Condition
Fibromyalgia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Evaluation of Sleep Disordered Breathing and Autonomic Dysfunction in Fibromyalgia Through Peripheral Arterial Tonometry

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Detailed Description:

Fibromyalgia Syndrome (FMS) is a clinical entity characterized by the presence of chronic, widespread pain and tenderness throughout the musculoskeletal system. FMS is considered to be a prototype of central pan syndromes, conditions in which augmentation of pain processing by the central nervous system in a major feature (1;2). As such, FMS overlaps with a number of similar "functional" disorders, including TMJD, IBS, Interstitial cystitis, Gulf war syndrome, chronic fatigue syndrome etc (3-5).

A major clinical feature of FMS is the presence of chronic fatigue, which is typically accompanied by a severely disrupted sleep pattern. Difficulty falling asleep, frequent awakening and non-refreshing sleep are all features classically reported by FMS patients. In addition, a number of classic sleep disturbances have been identified among FMS patients such as alpha - wave intrusion, disrupting normal stage IV sleep, as well as nocturnal falls in oxygen saturation (6). Notably, disturbed sleep may contribute not only to chronic fatigue, but also to enhanced pain processing as well as depression in FMS patients (7). Thus, pain inhibitory functions of the CNS, such as the process of Diffuse Noxious Inhibitory Control (DNIC) appear to be impaired in by sleep disruption (8).

Considerable interest has focused on the role of sleep apnea in FMS, as a possible factor contributing to fatigue and pain. Overt obstructive sleep apnea has been diagnosed in some patients (9) while more subtle disruptions of upper airway dynamics, such as increased upper airway pressure, not leading to total airway collapse, has been detected in many patients (10). Other researchers however have challenged the association of FMS with sleep apnea (11).

Autonomic dysfunction is another important clinical manifestation of FMS with common symptoms including presyncope / syncope, palpitations on standing and dizziness (12). Postural Orthostatic Tachycardia Syndrome (POTS) is another autonomic disorder which clinically overlaps with FMS (13).

Traditional polysomnography is a time-consuming and costly procedure, and hence, relatively few FMS patients are formally evaluated for sleep disorders in clinical practice.

The Watch-PATTM100 is a non-invasive device, which utilizes peripheral arterial tone (PAT), reflecting changes in autonomic nervous system function, as a marker for identifying and documenting respiratory disturbances during sleep. The PAT signal is acquired through a non-invasive probe attached to the finger during the sleep. Parameters measured include oxygen saturation, heart rate, sleep and wake states, REM and non-REM sleep.

The purpose of the current study is to use Peripheral Arterial Tonometry (PAT) in order to compare both disturbed sleep breathing and autonomic dysfunction in fibromyalgia patients and healthy controls.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients suffering from fibromyalgia recruited from the Tel Aviv Sourasky Medical center fibromyalgia clinic

Criteria

Inclusion Criteria:

Fibromyalgia group:

  • Patients over 18 years of age
  • Fulfilling ACR 1990 criteria for classification of Fibromyalgia

Exclusion Criteria:

  • Patients treated with benzodiazepines
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01151163

Locations
Israel
Tel Aviv Sourasky medical center Not yet recruiting
Tel Aviv, Israel
Contact: Jacob N Ablin, MD    972-3-6973668    kobby.ablin@gmail.com   
Principal Investigator: Jacob N Ablin, MD         
Tel Aviv Sourasky Medical Center Recruiting
Tel Aviv, Israel
Contact: Jacob N Ablin, MD    972-3-6973668    ajacob@tasmc.health.gov.il   
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Jacob N Ablin, MD Tel-Aviv Sourasky Medical Center
  More Information

No publications provided

Responsible Party: Jacob N Ablin, Institute of Rheumatology, Tel Aviv Sourasky medical center
ClinicalTrials.gov Identifier: NCT01151163     History of Changes
Other Study ID Numbers: 0154-10-TLV
Study First Received: June 24, 2010
Last Updated: February 7, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
Fibromyalgia, Peripheral arterial tonometry, sleep

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 16, 2014