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FibromyalgiaNCT01151163

Peripheral Arterial Tonometry (PAT) Evaluation of Sleep in Fibromyalgia

An observational study of Fibromyalgia, run by Tel-Aviv Sourasky Medical Center at 2 sites in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Fibromyalgia
How many people
100 participants
Where
2 sitesIsrael
Study dates
Jan 2011to Jul 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • Patients treated with benzodiazepines

Trial locations and contacts

2 sites in 1 country.

Israel2 sites, 2 recruiting
  • Tel Aviv Sourasky medical center

    Tel Aviv

    Jacob N Ablin, MD, 972-3-6973668, kobby.ablin@gmail.com

    Jacob N Ablin, MD

    Not yet recruiting
  • Tel Aviv Sourasky Medical Center

    Tel Aviv

    Jacob N Ablin, MD, 972-3-6973668, ajacob@tasmc.health.gov.il

    Recruiting

Other trials in Israel

About this study

Official title: Evaluation of Sleep Disordered Breathing and Autonomic Dysfunction in Fibromyalgia Through Peripheral Arterial Tonometry

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.

Read the 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.

Conditions
Fibromyalgia
Keywords
Fibromyalgia, Peripheral arterial tonometry, sleep
Medical subject headings
Fibromyalgia

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2010 (estimated)
  2. Study startJan 2011
  3. Primary completionJul 2011 (estimated)
  4. Study completionJul 2012 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01151163
Sponsor's protocol ID
0154-10-TLV
Status last verified
Feb 2011
First submitted
24 Jun 2010
Last updated
8 Feb 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Fibromyalgia, run by Tel-Aviv Sourasky Medical Center at 2 sites in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2011.

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