Fatigue in Primary Sjögren's Syndrome

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04802577
• Other study ID #: 2011-KAEK-25 2020/12-10
• Status: Completed
• Start date: January 4, 2021
• Est. completion date: July 30, 2021

Study information

• Verified date: November 2021
• Source: Bursa Yüksek Ihtisas Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: July 30, 2021
• Est. primary completion date: July 30, 2021
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Fatigue
• Fibromyalgia
• Pain Syndrome
• Sjogren's Syndrome
• Syndrome

Intervention

Diagnostic Test:
• FACT-F questionnaire
The questionnaire, based on patient report outcome data in which the presence of fatique is investigated in participants.
• Beck Depression Inventory
The questionnaire, based on patient report outcome data in which the presence of depression is investigated in participants.
• Beck Anxiety Inventory
The questionnaire, based on patient report outcome data in which the presence of anxiety is investigated in participants.
• Insomnia severity index.
The questionnaire, based on patient report outcome data in which the presence of insomnia is investigated in participants.

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

Locations

Country	Name	City	State
Turkey	Koray Ayar	Yildirim	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Bursa Yüksek Ihtisas Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FACIT-F	FUNCTIONAL ASSESSMENT OF CHRONIC ILLNESS THERAPY-FATIQUE	day 1
Secondary	BDI	Beck Depression Inventory	day 1
Secondary	BAI	Beck Anxiety Inventory	day 1
Secondary	ISS	Insomnia Severity Scale	day 1
Secondary	PDQ	Pain Detect Questionnaire	day 1