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Status unknownNCT01151163Updated Feb 8, 2011

Peripheral Arterial Tonometry (PAT) Evaluation of Sleep in Fibromyalgia

An observational study in Fibromyalgia, sponsored by Tel-Aviv Sourasky Medical Center. Status unknown at 2 sites in Israel. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-02-08.

Sponsored by Tel-Aviv Sourasky Medical Center · Observational

The sponsor has not verified this record recently (last verified Feb 2011), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
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Study 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. 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.

02

Conditions studied

  • Fibromyalgia

Keywords

  • Fibromyalgia, Peripheral arterial tonometry, sleep
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In context

Fibromyalgia

1,336 studies on the registry are indexed under Fibromyalgia; 266 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 270 observational studies indexed under Fibromyalgia.

Browse Fibromyalgia studies →

Lead sponsor

Tel-Aviv Sourasky Medical Center is the lead sponsor of 541 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

Inclusion criteria

Fibromyalgia group:

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

Exclusion criteria

Exclusion Criteria:

  • Patients treated with benzodiazepines
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
100 participants (estimated)
06

Study locations

1 of 2 sites recruiting
  • Tel Aviv Sourasky medical center
    Tel Aviv, Israel
    • Jacob N Ablin, MD · Contact · kobby.ablin@gmail.com · 972-3-6973668
    • Jacob N Ablin, MD · Principal investigator
    Not yet recruiting
  • Tel Aviv Sourasky Medical Center
    Tel Aviv, Israel
    Recruiting
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01151163
Lead sponsor
Tel-Aviv Sourasky Medical Center
First posted
Jun 25, 2010
Start date
Jan 2011
Primary completion
Jul 2011 (estimated)
Completion
Jul 2012 (estimated)
Last update
Feb 8, 2011

Study contacts

Jacob N Ablin, MD
principal investigator · Tel-Aviv Sourasky Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.

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