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Completed

NCT Number: NCT04802577

Fatigue in Primary Sjögren's Syndrome

Fatigue is a common clinical finding in Primary Sjögren's syndrome (PSS). In PSS, there is not enough data about the conditions in which fatigue develops and which clinical conditions the disease is associated with. This study was aimed to determine the level of fatigue in Primary Sjögren syndrome and to investigate the factors affecting the level of fatigue.

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Key information

Conditions

Sjogren's Syndrome Anxiety Anxiety Disorders Arthritis Arthritis, Rheumatoid Autoimmune Diseases Behavior Behavioral Symptoms Connective Tissue Diseases Depression Dry Eye Syndromes Eye Diseases Fatigue Fibromyalgia Immune System Diseases Joint Diseases Lacrimal Apparatus Diseases Mental Disorders Mouth Diseases Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Pain Syndrome Pathological Conditions, Signs and Symptoms Rheumatic Diseases Salivary Gland Diseases Signs and Symptoms Skin and Connective Tissue Diseases Somatoform Disorders Stomatognathic Diseases Xerostomia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Koray Ayar

Yıldırım, Bursa, 16310, Turkey (Türkiye)

About this study

While fatigue is seen with a prevalence of 7-8% in the normal population, it is more prevalent in Primary Sjögren's syndrome (PSS). In the studies conducted so far, the frequency of fatigue was seen at a frequency of over 30% in Primary Sjögren's syndrome. Although fatigue is so common in PSS, there is not enough data about the conditions in which fatigue develops in PSS. Other common conditions in PSS, apart from fatigue, are psychometric disorders such as common pain, depression and anxiety, and sleep disorders. In the studies conducted so far, each situation mentioned is common in PSS and seems to be related to each other. In the literature, there is no data on how many psychometric parameters, pain level, and insomnia affect fatigue and which are independent risk factors in PSS.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with PSS according to the 2016 ACR / EULAR criteria
  • Healthy hospital staff

Exclusion criteria

  • Pregnant women
  • Cancer patients
  • Those with other connective tissue diseases other than PSS
  • Multiple sclerosis patients
  • Chronic obstructive pulmonary disease
  • Those with heart failure and adrenal insufficiency
  • Those with renal failure: GFR <60 ml/min
  • Anemia: Hemoglobin <11 g / dl in women, hemoglobin <12 g / dl in men
  • Hypothyroidism: TSH >5 mu / L
  • Those with electrolyte disturbance

Treatment and study plan

FACT-F questionnaire

Diagnostic Test

The questionnaire, based on patient report outcome data in which the presence of fatique is investigated in participants.

Beck Depression Inventory

Diagnostic Test

The questionnaire, based on patient report outcome data in which the presence of depression is investigated in participants.

Beck Anxiety Inventory

Diagnostic Test

The questionnaire, based on patient report outcome data in which the presence of anxiety is investigated in participants.

Insomnia severity index.

Diagnostic Test

The questionnaire, based on patient report outcome data in which the presence of insomnia is investigated in participants.

ESSPRI

Other

The questionnaire, based on patient report outcome data in which the severity of Sjögren's syndrome is investigated in participants.

ESSDAI

Other

Activity scale in which the activity of Sjögren's syndrome is evaluated based on the laboratory and imaging tests of the patients and the examination findings of the evaluator.

Pain Detect Questionnaire

Other

The questionnaire, based on patient report outcome data in which the severity and extent of pain in the body are investigated in participants.

Primary outcomes

  1. FACIT-F

    Time frame: day 1

    FUNCTIONAL ASSESSMENT OF CHRONIC ILLNESS THERAPY-FATİQUE

Secondary outcomes

  1. BDI

    Time frame: day 1

    Beck Depression Inventory

  2. BAI

    Time frame: day 1

    Beck Anxiety Inventory

  3. ISS

    Time frame: day 1

    Insomnia Severity Scale

  4. PDQ

    Time frame: day 1

    Pain Detect Questionnaire

Sponsors and collaborators

Lead sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Other Gov

Registry information

Official study title

The Level of Fatigue and Its Relationship With Disease Activity, Pain, Insomnia, and Psychometric Parameters in Primary Sjögren's Syndrome

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 17, 2021
Registry last updated
Dec 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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