FibromyalgiaNCT03823937
Evaluation of Smell and Taste in Fibromyalgia
An observational study of Fibromyalgia, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
Patients diagnosed with fibromyalgia syndrome according to 2016 ACR criteria and 18-70 years old healthy subjects will be included in the study. Their smell and taste will be assessed with sniffin sticks and taste strips. Besides they will be evaluated for quality of life, anxiety, depression, and alexithymia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Sniffin' Sticks test and Taste strips
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2019to 10 Jun 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- Adult, Older adult
Study population: 18-70 years old fibromyalgia diagnosed with 2016 ACR criteria and age, sex-matched healthy controls will be included in the study.
Who may be able to join
- 18-70 years of fibromyalgia patients
- Giving informed consent
- Knowing how to write and read in Turkish
Who cannot join
- Mentally retarded patients
- Psychiatric disorders (bipolar disorder, schizophrenia etc.)
- Severe organ failure (kidney, liver, heart failure)
- History of head trauma
- Any disorder associated with smell and taste functions
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sultan Abdulhamid Han Training and Research Hospital
Istanbul
About this study
Official title: Evaluation of Smell and Taste in Patients With Fibromyalgia
Patients diagnosed with fibromyalgia syndrome according to 2016 ACR criteria and 18-70 years old healthy subjects will be included in the study. Their smell and taste will be assessed with sniffin sticks and taste strips. Besides they will be evaluated for quality of life, anxiety, depression, and alexithymia.
- Conditions
- Fibromyalgia
- Being tested
- Sniffin' Sticks test and Taste strips
- Keywords
- fibromyalgia, smell, taste
- Medical subject headings
- Fibromyalgia, Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sniffin' Sticks test and Taste stripsOther
Sniffin' Sticks test (Burghardt®, Wedel, Germany) is a psychophysical test. It allows semi-objective assessment of the patient's olfactory performance by means of 3 subtests: threshold test, identification test and discrimination test. The Sniffin' Sticks Olfactory Test Kits contain pen like bodies as, for example, in pens used to write on flipcharts or whiteboards.These pen-like bodies, however, contain a fibre stick which is filled with scents. For testing, the cap should be removed so the patient can smell on the tip of the pen.
The taste strips are a validated examination procedure to investigate the taste ability. When testing the whole mouth taste ability, the taste strips are applied by putting them on the tongue and closing the mouth.
| Study group | Role | What they receive |
|---|---|---|
| Fibromyalgia | Diagnosed with ACR 2016 criteria Receives: Other: Sniffin' Sticks test and Taste strips | |
| Control | 18-70 years healthy subjects Receives: Other: Sniffin' Sticks test and Taste strips |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sniffin' Sticks Test Score
total smell test score minimum score: 0 maximum score: 48 Higher scores reflect better smell function.
Measured: Baseline
Taste Strips Test Score
total taste score minimum score: 0 maximum score: 16 Higher scores indicate better taste function.
Measured: Baseline
Secondary outcomes (4)
Quality of Life Score
A EQ-5D-3L is a standardized instrument for measuring generic health status. minimum score: -0.59 maximum score: 1 Higher scores indicate better health status.
Measured: Baseline
Anxiety Score
Hamilton anxiety scale: Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Measured: Baseline
Alexithymia Score
Toronto alexithymia scale minimum score: 20 maximum score: 100 Cut-off scores: ≤50=no alexithymia, 51-60=borderline alexithymia, and ≥61=alexithymia
Measured: Baseline
Depression Score
Hamilton depression scale is designed to rate the severity of depression in patients. Although it contains 21 areas, calculate the patient's score on the first 17 answers.
Minimum score:0 Maximum score: 53 Higher scores reflect more severe depression.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start2 Jan 2019
- Primary completion2 Jun 2019
- Study completion10 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies 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
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823937
- Sponsor's protocol ID
- Tugba Ozsoy2
- Status last verified
- May 2020
- First submitted
- 27 Jan 2019
- Last updated
- 11 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hur K, Choi JS, Zheng M, Shen J, Wrobel B. Association of alterations in smell and taste with depression in older adults. Laryngoscope Investig Otolaryngol. 2018 Feb 21;3(2):94-99. doi: 10.1002/lio2.142. eCollection 2018 Apr.
PubMed 29721540Lotsch J, Kraetsch HG, Wendler J, Hummel T. Self-ratings of higher olfactory acuity contrast with reduced olfactory test results of fibromyalgia patients. Int J Psychophysiol. 2012 Nov;86(2):182-6. doi: 10.1016/j.ijpsycho.2012.09.003. Epub 2012 Sep 15.
PubMed 22985737
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Smell and Taste in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT03823937
- Acronym / sponsor ID
- Tugba Ozsoy2
- Conditions
- Fibromyalgia
- Keywords
- fibromyalgia, smell, taste
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 2 Jun 2019 (actual)
- Study completion
- 10 Jun 2019 (actual)
- First posted
- 31 Jan 2019 (actual)
- Results
- Posted 11 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients diagnosed with fibromyalgia syndrome according to 2016 ACR criteria and 18-70 years old healthy subjects will be included in the study. Their smell and taste will be assessed with sniffin sticks and taste strips. Besides they will be evaluated for quality of life, anxiety, depression, and alexithymia.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibromyalgia | – | Other: Sniffin' Sticks test and Taste stripsDiagnosed with ACR 2016 criteria |
| Control | – | Other: Sniffin' Sticks test and Taste strips18-70 years healthy subjects |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 18-70 years old fibromyalgia diagnosed with 2016 ACR criteria and age, sex-matched healthy controls will be included in the study.
Key inclusion criteria (3 listed)
- 18-70 years of fibromyalgia patients
- Giving informed consent
- Knowing how to write and read in Turkish
Key exclusion criteria (5 listed)
- Mentally retarded patients
- Psychiatric disorders (bipolar disorder, schizophrenia etc.)
- Severe organ failure (kidney, liver, heart failure)
- History of head trauma
- Any disorder associated with smell and taste functions
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 |
|---|---|---|
| Sniffin' Sticks test and Taste stripsSniffin' Sticks test (Burghardt®, Wedel, Germany) is a psychophysical test. It allows semi-objective assessment of the patient's olfactory performance by means of 3 subtests: threshold test, identification test and discrimination test. The Sniffin' Sticks Olfactory Test Kits contain pen like bodies as, for example, in pens used to write on flipcharts or whiteboards.These pen-like bodies, however, contain a fibre stick which is filled with scents. For testing, the cap should be removed so the patient can smell on the tip of the pen. The taste strips are a validated examination procedure to investigate the taste ability. When testing the whole mouth taste ability, the taste strips are applied by putting them on the tongue and closing the mouth. | Other | Control, Fibromyalgia |
Primary outcome
Sniffin' Sticks Test Score
Time frame: Baseline
total smell test score minimum score: 0 maximum score: 48 Higher scores reflect better smell function.
Taste Strips Test Score
Time frame: Baseline
total taste score minimum score: 0 maximum score: 16 Higher scores indicate better taste function.
4 secondary outcomes
Quality of Life Score
Time frame: Baseline
Anxiety Score
Time frame: Baseline
Alexithymia Score
Time frame: Baseline
Depression Score
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29721540Hur K, Choi JS, Zheng M, Shen J, Wrobel B. Association of alterations in smell and taste with depression in older adults. Laryngoscope Investig Otolaryngol. 2018 Feb 21;3(2):94-99. doi: 10.1002/lio2.142. eCollection 2018 Apr.
- Background: PubMed 22985737Lotsch J, Kraetsch HG, Wendler J, Hummel T. Self-ratings of higher olfactory acuity contrast with reduced olfactory test results of fibromyalgia patients. Int J Psychophysiol. 2012 Nov;86(2):182-6. doi: 10.1016/j.ijpsycho.2012.09.003. Epub 2012 Sep 15.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Fibromyalgia, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey 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 3 inclusion and 5 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 11 Jun 2020. 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?
Yes. Results are posted in the registry (first posted 11 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sniffin' Sticks Test Score (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03823937, which also lists 2 linked publications.
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 11 Jun 2020.