ChronotypeNCT06197087
Evaluation of Chronotype and Central Sensitization in Patients With Fibromyalgia Syndrome
An observational study of Chronotype and Fibromyalgia Syndrome, run by Oğuzhan Kandemir at 1 site in Turkey (Türkiye).
Trial summary
The aim of study is to examine the chronotype preferences of patients with fibromyalgia syndrome and the relationship between central sensitization and chronotype, and to examine its relationship with pain intensity, disability and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Chronotype, Fibromyalgia Syndrome
- What is being tested?
- cross-sectional observational survey study
- How many people
- 500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2023to 15 Dec 2024
- How long will I take part?
- 3 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients who applied to Yerköy State Hospital Physical Medicine and Rehabilitation Polyclinic and Afyonkarahisar Health Sciences University Faculty of Medicine Hospital Physical Medicine and Rehabilitation Polyclinic and were followed up with the diagnosis of FMS for at least 3 months will be included in the study.
Who may be able to join
- Being diagnosed according to ACR 2016 Fibromyalgia Syndrome Diagnostic criteria Continuing complaints for at least 3 months
Who cannot join
- Neurological and Inflammatory diseases Pregnancy Malignancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Afyonkarahisar Health Sciences University
Afyonkarahisar, 03200
oğuzhan kandemir, +905357400335, md.oguzhankandemir@gmail.com
Sevda ADAR, +905325940725, drsevdaadar@gmail.com
About this study
Official title: Evaluation of Chronotype and Central Sensitization in Patients With Fibromyalgia Syndrome, Cross-sectional Study
The aim of study is to examine the chronotype preferences of patients with fibromyalgia syndrome and the relationship between central sensitization and chronotype, and to examine its relationship with pain intensity, disability and quality of life.
Read the detailed description
Fibromyalgia Syndrome (FMS); It is a syndrome characterized by chronic pain occurring in more than one part of the body and accompanied by fatigue, sleep disturbance, impairment in quality of life and daily functionality. Although FMS is seen in different age groups, it is most common in middle-aged women. FMS is classified as central sensitization syndrome, in which there is an abnormal response to painful stimuli and the processing of nociceptive stimuli in the central nervous system. In patients with FMS, pain may cause sleep disturbances such as non-restorative sleep or difficulty initiating or maintaining sleep. It is estimated that 65-99% of patients with FMS experience sleep disorders. Circadian rhythms reflect 24-hour physiological and behavioral cycles within each individual. Based on individual differences in the timing of these innate rhythms, individuals can be divided into 3 phenotypes (i.e., chronotypes): morning type (M-highest level of alertness in the morning), evening type (E most active in the evening), and intermediate type (I-neither M nor E). Chronotype is explained by both genetic and environmental factors and can be considered a fairly robust trait throughout adulthood. A study assessing 1548 people with FMS with an online survey including questions about sleep quality, well-being, pain, chronotype and FMS impact shows that late chronotypes are more affected by fibromyalgia. In another study conducted in 2019, patients with FMS were grouped according to chronotype preferences and showed that there was a strong relationship between FMS severity and poor quality of life in evening individuals.
The aim of study is to examine the chronotype preferences of patients with fibromyalgia syndrome and the relationship between central sensitization and chronotype, and to examine its relationship with pain intensity, disability and quality of life.
- Conditions
- Chronotype, Fibromyalgia Syndrome
- Being tested
- cross-sectional observational survey study
- Keywords
- fibromyalgia syndrome, Chronotype, central sensitization, disability, quality of life
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cross-sectional observational survey studyOther
Patients' pain intensity (with VAS), quality of life (with SF-12), sleep quality (with Pittsburgh sleep quality scale), anxiety and depression symptoms (with Beck Depression Inventory), cognitive aspect of pain (with Pain Catastrophizing Scale), presence of central sensitization (with the central sensitization scale), functional status (with the Fibromyalgia impact questionnaire), and chronotype preferences will be evaluated with the Morningness and Eveningness Questionnaire.
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Sensitization Inventory
Central Sensitization Inventory (CSI) The CSI is a two-part questionnaire that contains a 25-item survey (Part A) that assesses the frequency of health-related symptoms associated with central sensitivity syndromes and a brief survey (Part B) asking if patients have been diagnosed with specific disorders (Neblett et al., 2013). For the purposes of this study, only responses from the 25-item survey were included. Participants are asked to rate each question on a 5-point scale with 0 meaning "never" and 4 meaning "always." A summed response is obtained with a total possible score of 100. Higher CSI scores represent greater self-reported symptomology. A cutoff score of 40 or greater has shown acceptable psychometrics for identifying patients with central sensitivity syndromes
Measured: 1 hour
Morning and Evening Survey
Sleep is one of the most commonly used tools to assess chronotype preferences. This screening questionnaire, consisting of 19 items, has a rating range between 16 and 86. Scoring results were classified as follows: evening types scoring between 16 and 41, morning types scoring between 59 and 86, and no types scoring between 42 and 58. The Turkish version has been shown to have good validity and reliability.
Measured: 1 hour
Fibromyalgia Impact Survey
It was developed by Burckhardt and his colleagues in 1991. It is the most commonly used scale to evaluate functional status in patients with FMS. It evaluates 10 different characteristics, including physical functioning, well-being, missed work days, difficulty at work, pain, fatigue, morning fatigue, stiffness, anxiety and depression. The total score varies between 0 and 80. A high score indicates that the disease affects the person more. Cronbach's alpha coefficient for all items was 0.73.
Measured: 1 hour
Secondary outcomes (5)
VAS
Visual Pain Scale (VAS), which is easy to understand, apply and interpret and provides valid and reliable data in a short time, is the most used method in clinics. Using a 100 mm visual linear scale, the patient is told that at point 0 there is no pain, and at point 100 it is the most severe pain ever felt in life, and the patient is asked to place a mark on the point corresponding to his pain.
Measured: 1 hour
Pittsburg Sleep Quality Index (PSQI)
The first 18 questions answered by the participant are used in calculating the PSQI total score and component scores. The 18 questions answered by the participant included sleep quality (component 1), sleep latency (component 2), sleep duration (component 3), habitual sleep efficiency (component 4), sleep disturbance (component 5), sleep medication use (component 6), and It provides information about 7 components, including daytime sleep dysfunction (component 7). Each component is evaluated on a scale of 0-3 points. The sum of these 7 component scores gives the total PSQI score. The total PSQI score varies between 0-21. While the sleep quality of individuals with a total score of 5 or less is considered "good", the sleep quality of individuals with a score above 5 is considered "bad".
Measured: 1 hour
Beck Depression Anxiety Scale
Beck Depression Inventory is a self-rating scale consisting of 21 items. Each item was given a score between 0 and 3, the highest score that could be obtained from the scale was 63 and the lowest score was 0. A high score from the scale indicates that the severity or level of depression is high.
Measured: 1 hour
Pain Catastrophizing Scale
Sullivan et al. It is a 13-item self-report inventory using a 5-point Likert scale (0-4) developed by To measure the extent to which people catastrophize in response to pain. The original scale consists of three sub-factors called helplessness, magnification and rumination.
Measured: 1 hour
SF-12
SF-12 is an easy-to-administer survey with proven reliability and validity, obtained by shortening and simplifying the SF-36. It is used to evaluate physical and mental health, the two main components of general health status. Consisting of twelve questions, SF-12 has mental and physical component scores. High scores indicate good health.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start15 Dec 2023
- Primary completion15 Mar 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for ChronotypeStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Oğuzhan Kandemir
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Oğuzhan Kandemir, Afyonkarahisar Health Sciences University
- Investigators
- sevda adar, Principal investigator, Afyonkarahisar Health Sciences Universityümit dündar, Principal investigator, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06197087
- Sponsor's protocol ID
- chronotypeandfibromyalgia2023
- Status last verified
- Jan 2024
- First submitted
- 10 Dec 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Andrade A, Vilarino GT, Sieczkowska SM, Coimbra DR, Bevilacqua GG, Steffens RAK. The relationship between sleep quality and fibromyalgia symptoms. J Health Psychol. 2020 Aug;25(9):1176-1186. doi: 10.1177/1359105317751615. Epub 2018 Jan 8.
PubMed 29310453Boomershine CS. Fibromyalgia: the prototypical central sensitivity syndrome. Curr Rheumatol Rev. 2015;11(2):131-45. doi: 10.2174/1573397111666150619095007.
PubMed 26088213Fitzcharles MA, Ste-Marie PA, Goldenberg DL, Pereira JX, Abbey S, Choiniere M, Ko G, Moulin DE, Panopalis P, Proulx J, Shir Y; National Fibromyalgia Guideline Advisory Panel. 2012 Canadian Guidelines for the diagnosis and management of fibromyalgia syndrome: executive summary. Pain Res Manag. 2013 May-Jun;18(3):119-26. doi: 10.1155/2013/918216.
PubMed 23748251Theadom A, Cropley M, Humphrey KL. Exploring the role of sleep and coping in quality of life in fibromyalgia. J Psychosom Res. 2007 Feb;62(2):145-51. doi: 10.1016/j.jpsychores.2006.09.013.
PubMed 17270572Turkoglu G, Selvi Y. The relationship between chronotype, sleep disturbance, severity of fibromyalgia, and quality of life in patients with fibromyalgia. Chronobiol Int. 2020 Jan;37(1):68-81. doi: 10.1080/07420528.2019.1684314. Epub 2019 Nov 5.
PubMed 31687843Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.
PubMed 20461783Czeisler CA, Gooley JJ. Sleep and circadian rhythms in humans. Cold Spring Harb Symp Quant Biol. 2007;72:579-97. doi: 10.1101/sqb.2007.72.064.
PubMed 18419318Barclay NL, Rowe R, O'Leary R, Bream D, Gregory AM. Longitudinal Stability of Genetic and Environmental Influences on the Association between Diurnal Preference and Sleep Quality in Young Adult Twins and Siblings. J Biol Rhythms. 2016 Aug;31(4):375-86. doi: 10.1177/0748730416653533. Epub 2016 Jun 23.
PubMed 27339174
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Chronotype and Central Sensitization in Patients With Fibromyalgia Syndrome, Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06197087
- Acronym / sponsor ID
- chronotypeandfibromyalgia2023
- Conditions
- Chronotype, Fibromyalgia Syndrome
- Keywords
- fibromyalgia syndrome, Chronotype, central sensitization, disability, quality of life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Oğuzhan KandemirUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 15 Mar 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 9 Jan 2024 (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.
The aim of study is to examine the chronotype preferences of patients with fibromyalgia syndrome and the relationship between central sensitization and chronotype, and to examine its relationship with pain intensity, disability and quality of life.
Detailed description
Fibromyalgia Syndrome (FMS); It is a syndrome characterized by chronic pain occurring in more than one part of the body and accompanied by fatigue, sleep disturbance, impairment in quality of life and daily functionality. Although FMS is seen in different age groups, it is most common in middle-aged women. FMS is classified as central sensitization syndrome, in which there is an abnormal response to painful stimuli and the processing of nociceptive stimuli in the central nervous system. In patients with FMS, pain may cause sleep disturbances such as non-restorative sleep or difficulty initiating or maintaining sleep. It is estimated that 65-99% of patients with FMS experience sleep disorders. Circadian rhythms reflect 24-hour physiological and behavioral cycles within each individual. Based on individual differences in the timing of these innate rhythms, individuals can be divided into 3 phenotypes (i.e., chronotypes): morning type (M-highest level of alertness in the morning), evening type (E most active in the evening), and intermediate type (I-neither M nor E). Chronotype is explained by both genetic and environmental factors and can be considered a fairly robust trait throughout adulthood. A study assessing 1548 people with FMS with an online survey including questions about sleep quality, well-being, pain, chronotype and FMS impact shows that late chronotypes are more affected by fibromyalgia. In another study conducted in 2019, patients with FMS were grouped according to chronotype preferences and showed that there was a strong relationship between FMS severity and poor quality of life in evening individuals.
The aim of study is to examine the chronotype preferences of patients with fibromyalgia syndrome and the relationship between central sensitization and chronotype, and to examine its relationship with pain intensity, disability and quality of life.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients who applied to Yerköy State Hospital Physical Medicine and Rehabilitation Polyclinic and Afyonkarahisar Health Sciences University Faculty of Medicine Hospital Physical Medicine and Rehabilitation Polyclinic and were followed up with the diagnosis of FMS for at least 3 months will be included in the study.
Key inclusion criteria (1 listed)
- Being diagnosed according to ACR 2016 Fibromyalgia Syndrome Diagnostic criteria Continuing complaints for at least 3 months
Key exclusion criteria (1 listed)
- Neurological and Inflammatory diseases Pregnancy Malignancy
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 |
|---|---|---|
| cross-sectional observational survey studyPatients' pain intensity (with VAS), quality of life (with SF-12), sleep quality (with Pittsburgh sleep quality scale), anxiety and depression symptoms (with Beck Depression Inventory), cognitive aspect of pain (with Pain Catastrophizing Scale), presence of central sensitization (with the central sensitization scale), functional status (with the Fibromyalgia impact questionnaire), and chronotype preferences will be evaluated with the Morningness and Eveningness Questionnaire. | Other | – |
Primary outcome
Central Sensitization Inventory
Time frame: 1 hour
Central Sensitization Inventory (CSI) The CSI is a two-part questionnaire that contains a 25-item survey (Part A) that assesses the frequency of health-related symptoms associated with central sensitivity syndromes and a brief survey (Part B) asking if patients have been diagnosed with specific disorders (Neblett et al., 2013). For the purposes of this study, only responses from the 25-item survey were included. Participants are asked to rate each question on a 5-point scale with 0 meaning "never" and 4 meaning "always." A summed response is obtained with a total possible score of 100. Higher CSI scores represent greater self-reported symptomology. A cutoff score of 40 or greater has shown acceptable psychometrics for identifying patients with central sensitivity syndromes
Morning and Evening Survey
Time frame: 1 hour
Sleep is one of the most commonly used tools to assess chronotype preferences. This screening questionnaire, consisting of 19 items, has a rating range between 16 and 86. Scoring results were classified as follows: evening types scoring between 16 and 41, morning types scoring between 59 and 86, and no types scoring between 42 and 58. The Turkish version has been shown to have good validity and reliability.
Fibromyalgia Impact Survey
Time frame: 1 hour
It was developed by Burckhardt and his colleagues in 1991. It is the most commonly used scale to evaluate functional status in patients with FMS. It evaluates 10 different characteristics, including physical functioning, well-being, missed work days, difficulty at work, pain, fatigue, morning fatigue, stiffness, anxiety and depression. The total score varies between 0 and 80. A high score indicates that the disease affects the person more. Cronbach's alpha coefficient for all items was 0.73.
5 secondary outcomes
VAS
Time frame: 1 hour
Pittsburg Sleep Quality Index (PSQI)
Time frame: 1 hour
Beck Depression Anxiety Scale
Time frame: 1 hour
Pain Catastrophizing Scale
Time frame: 1 hour
SF-12
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Background: PubMed 29310453Andrade A, Vilarino GT, Sieczkowska SM, Coimbra DR, Bevilacqua GG, Steffens RAK. The relationship between sleep quality and fibromyalgia symptoms. J Health Psychol. 2020 Aug;25(9):1176-1186. doi: 10.1177/1359105317751615. Epub 2018 Jan 8.
- Background: PubMed 26088213Boomershine CS. Fibromyalgia: the prototypical central sensitivity syndrome. Curr Rheumatol Rev. 2015;11(2):131-45. doi: 10.2174/1573397111666150619095007.
- Background: PubMed 23748251Fitzcharles MA, Ste-Marie PA, Goldenberg DL, Pereira JX, Abbey S, Choiniere M, Ko G, Moulin DE, Panopalis P, Proulx J, Shir Y; National Fibromyalgia Guideline Advisory Panel. 2012 Canadian Guidelines for the diagnosis and management of fibromyalgia syndrome: executive summary. Pain Res Manag. 2013 May-Jun;18(3):119-26. doi: 10.1155/2013/918216.
- Background: PubMed 17270572Theadom A, Cropley M, Humphrey KL. Exploring the role of sleep and coping in quality of life in fibromyalgia. J Psychosom Res. 2007 Feb;62(2):145-51. doi: 10.1016/j.jpsychores.2006.09.013.
- Background: PubMed 31687843Turkoglu G, Selvi Y. The relationship between chronotype, sleep disturbance, severity of fibromyalgia, and quality of life in patients with fibromyalgia. Chronobiol Int. 2020 Jan;37(1):68-81. doi: 10.1080/07420528.2019.1684314. Epub 2019 Nov 5.
- Background: PubMed 20461783Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.
- Background: PubMed 18419318Czeisler CA, Gooley JJ. Sleep and circadian rhythms in humans. Cold Spring Harb Symp Quant Biol. 2007;72:579-97. doi: 10.1101/sqb.2007.72.064.
- Background: PubMed 27339174Barclay NL, Rowe R, O'Leary R, Bream D, Gregory AM. Longitudinal Stability of Genetic and Environmental Influences on the Association between Diurnal Preference and Sleep Quality in Young Adult Twins and Siblings. J Biol Rhythms. 2016 Aug;31(4):375-86. doi: 10.1177/0748730416653533. Epub 2016 Jun 23.
- 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.
sevda adar principal investigator
Afyonkarahisar Health Sciences University
ümit dündar principal investigator
Afyonkarahisar Health Sciences University
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 Chronotype and Fibromyalgia Syndrome, run by Oğuzhan Kandemir 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact oğuzhan kandemir (+905357400335, md.oguzhankandemir@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central Sensitization Inventory (time frame: 1 hour). The study lists 3 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 NCT06197087, which also lists 8 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 17 Jan 2024.