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Fatigue in Primary Sjögren's Syndrome

NCT ID: NCT04802577

Last Updated: 2021-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-04

Study Completion Date

2021-07-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sjogren's Syndrome Fatigue Pain Syndrome Depression Anxiety Fibromyalgia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Primary Sjögren's syndrome

The patient's diagnosed with Primary Sjögren's according to 2016 ACR/EULAR classification criteria

FACT-F questionnaire

Intervention Type DIAGNOSTIC_TEST

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

Beck Depression Inventory

Intervention Type DIAGNOSTIC_TEST

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

Beck Anxiety Inventory

Intervention Type DIAGNOSTIC_TEST

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

Insomnia severity index.

Intervention Type DIAGNOSTIC_TEST

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

ESSPRI

Intervention Type OTHER

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

ESSDAI

Intervention Type 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

Intervention Type OTHER

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

Healthy Controls

Healthy hospital workers without any chronic disease

FACT-F questionnaire

Intervention Type DIAGNOSTIC_TEST

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

Beck Depression Inventory

Intervention Type DIAGNOSTIC_TEST

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

Beck Anxiety Inventory

Intervention Type DIAGNOSTIC_TEST

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

Insomnia severity index.

Intervention Type DIAGNOSTIC_TEST

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

Pain Detect Questionnaire

Intervention Type OTHER

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

Interventions

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FACT-F questionnaire

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

Intervention Type DIAGNOSTIC_TEST

Beck Depression Inventory

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

Intervention Type DIAGNOSTIC_TEST

Beck Anxiety Inventory

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

Intervention Type DIAGNOSTIC_TEST

Insomnia severity index.

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

Intervention Type DIAGNOSTIC_TEST

ESSPRI

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

Intervention Type OTHER

ESSDAI

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.

Intervention Type OTHER

Pain Detect Questionnaire

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bursa Yuksek Ihtisas Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Koray Ayar

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Koray Ayar, M.D.

Role: PRINCIPAL_INVESTIGATOR

Univesity of Health Science, Bursa Yuksek Ihtisas Training and Research Hospital

Locations

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Koray Ayar

Yıldırım, Bursa, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2011-KAEK-25 2020/12-10

Identifier Type: -

Identifier Source: org_study_id