Sjogren's SyndromeNCT04802577
Fatigue in Primary Sjögren's Syndrome
An observational study of Sjogren's Syndrome and Fatigue, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sjogren's Syndrome, Fatigue, Pain Syndrome
- What is being tested?
- FACT-F questionnaire, Beck Depression Inventory and Beck Anxiety Inventory
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Jan 2021to 30 Jul 2021
- How long will I take part?
- 6 Months
- 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 to 65 years
- All sexes
- Adult, Older adult
Study population: Volunteers who were followed up with a diagnosis of PSS in the center where the study was conducted and met the inclusion and exclusion criteria.
Who may be able to join
- Patients diagnosed with PSS according to the 2016 ACR / EULAR criteria
- Healthy hospital staff
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Level of Fatigue and Its Relationship With Disease Activity, Pain, Insomnia, and Psychometric Parameters 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.
Read the detailed 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.
- Conditions
- Sjogren's Syndrome, Fatigue, Pain Syndrome, Depression, Anxiety, Fibromyalgia
- Being tested
- FACT-F questionnaire, Beck Depression Inventory, Beck Anxiety Inventory, Insomnia severity index., ESSPRI
- Medical subject headings
- Sjogren's Syndrome, Fatigue, Somatoform Disorders, Depression, Anxiety Disorders, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FACT-F questionnaireDiagnostic test
The questionnaire, based on patient report outcome data in which the presence of fatique is investigated in participants.
Beck Depression InventoryDiagnostic test
The questionnaire, based on patient report outcome data in which the presence of depression is investigated in participants.
Beck Anxiety InventoryDiagnostic 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.
ESSPRIOther
The questionnaire, based on patient report outcome data in which the severity of Sjögren's syndrome is investigated in participants.
ESSDAIOther
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 QuestionnaireOther
The questionnaire, based on patient report outcome data in which the severity and extent of pain in the body are investigated in participants.
| Study group | Role | What they receive |
|---|---|---|
| Primary Sjögren's syndrome | The patient's diagnosed with Primary Sjögren's according to 2016 ACR/EULAR classification criteria Receives: Diagnostic Test: FACT-F questionnaire; Diagnostic Test: Beck Depression Inventory; Diagnostic Test: Beck Anxiety Inventory; Diagnostic Test: Insomnia severity index.; Other: ESSPRI; Other: ESSDAI; Other: Pain Detect Questionnaire | |
| Healthy Controls | Healthy hospital workers without any chronic disease Receives: Diagnostic Test: FACT-F questionnaire; Diagnostic Test: Beck Depression Inventory; Diagnostic Test: Beck Anxiety Inventory; Diagnostic Test: Insomnia severity index.; Other: Pain Detect Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
FACIT-F
FUNCTIONAL ASSESSMENT OF CHRONIC ILLNESS THERAPY-FATİQUE
Measured: day 1
Secondary outcomes (4)
BDI
Beck Depression Inventory
Measured: day 1
BAI
Beck Anxiety Inventory
Measured: day 1
ISS
Insomnia Severity Scale
Measured: day 1
PDQ
Pain Detect Questionnaire
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start4 Jan 2021
- Primary completion30 Jul 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjogren's SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 110 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Koray Ayar, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Koray Ayar, M.D., Principal investigator, Univesity of Health Science, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04802577
- Sponsor's protocol ID
- 2011-KAEK-25 2020/12-10
- Status last verified
- Sep 2026
- First submitted
- 14 Mar 2021
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Level of Fatigue and Its Relationship With Disease Activity, Pain, Insomnia, and Psychometric Parameters in Primary Sjögren's Syndrome
- ClinicalTrials.gov ID
- NCT04802577
- Acronym / sponsor ID
- 2011-KAEK-25 2020/12-10
- Conditions
- Sjogren's Syndrome, Fatigue, Pain Syndrome, Depression, Anxiety, Fibromyalgia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 17 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Sjögren's syndrome | – | Diagnostic Test: FACT-F questionnaire, Diagnostic Test: Beck Depression Inventory, Diagnostic Test: Beck Anxiety Inventory, Diagnostic Test: Insomnia severity index., Other: ESSPRI, Other: ESSDAI, Other: Pain Detect QuestionnaireThe patient's diagnosed with Primary Sjögren's according to 2016 ACR/EULAR classification criteria |
| Healthy Controls | – | Diagnostic Test: FACT-F questionnaire, Diagnostic Test: Beck Depression Inventory, Diagnostic Test: Beck Anxiety Inventory, Diagnostic Test: Insomnia severity index., Other: Pain Detect QuestionnaireHealthy hospital workers without any chronic disease |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Volunteers who were followed up with a diagnosis of PSS in the center where the study was conducted and met the inclusion and exclusion criteria.
Key inclusion criteria (2 listed)
- Patients diagnosed with PSS according to the 2016 ACR / EULAR criteria
- Healthy hospital staff
Key exclusion criteria (10 listed)
- Pregnant women
- Cancer patients
- Those with other connective tissue diseases other than PSS
- Multiple sclerosis patients
- Chronic obstructive pulmonary disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FACT-F questionnaireThe questionnaire, based on patient report outcome data in which the presence of fatique is investigated in participants. | Diagnostic test | Healthy Controls, Primary Sjögren's syndrome |
| Beck Depression InventoryThe questionnaire, based on patient report outcome data in which the presence of depression is investigated in participants. | Diagnostic test | Healthy Controls, Primary Sjögren's syndrome |
| Beck Anxiety InventoryThe questionnaire, based on patient report outcome data in which the presence of anxiety is investigated in participants. | Diagnostic test | Healthy Controls, Primary Sjögren's syndrome |
| Insomnia severity index.The questionnaire, based on patient report outcome data in which the presence of insomnia is investigated in participants. | Diagnostic test | Healthy Controls, Primary Sjögren's syndrome |
| ESSPRIThe questionnaire, based on patient report outcome data in which the severity of Sjögren's syndrome is investigated in participants. | Other | Primary Sjögren's syndrome |
| ESSDAIActivity 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. | Other | Primary Sjögren's syndrome |
| Pain Detect QuestionnaireThe questionnaire, based on patient report outcome data in which the severity and extent of pain in the body are investigated in participants. | Other | Healthy Controls, Primary Sjögren's syndrome |
Primary outcome
FACIT-F
Time frame: day 1
FUNCTIONAL ASSESSMENT OF CHRONIC ILLNESS THERAPY-FATİQUE
4 secondary outcomes
BDI
Time frame: day 1
BAI
Time frame: day 1
ISS
Time frame: day 1
PDQ
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Koray Ayar, M.D. principal investigator
Univesity of Health Science, Bursa Yuksek Ihtisas Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sjogren's Syndrome and Fatigue, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 10 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: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FACIT-F (time frame: day 1). It is what the study was designed to measure, not a finding.
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 1 Oct 2026.