Fibromyalgia, PrimaryNCT06595771
Obstructive Sleep Apnea Syndrome and Fibromiyalgia
An observational study of Fibromyalgia, Primary, run by Haydarpasa Numune Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
-------------Obstructive sleep apnea syndrome (OSAS) is a syndrome characterized by recurrent complete (apnea) or partial (hypopnea) upper respiratory tract obstruction episodes during sleep and a decrease in blood oxygen saturation. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Fibromyalgia, Primary
- What is being tested?
- continuous positive airway pressure and Polysomnography
- Type of treatment
- Medical device
- How many people
- 225 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2018to 1 Feb 2019
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients between 30-65 years of age who were diagnosed with OSAS according to American Academy of Sleep Medicine (AASM) criteria and who had clinical symptoms of OSAS for at least 1 year before diagnosis will be performed. All OSAS patients recommended and not recommended for CPAP treatment in the sleep clinic will be evaluated according to the American Rheumatology Association (ACR) 1990 and 2016 criteria for FMS. Patients meeting both criteria will be accepted as FMS.
Who may be able to join
- Being between the ages of 1-30-65
- Being diagnosed with Obstructive Sleep apnea syndrome and/or having CPAP treatment indication
Who cannot join
- Chronic inflammatory or autoimmune disease
- hyperthyroidism/hyperthyroidism
- Cognitive dysfunction (such as dementia)
- Severe psychiatric disorder
- Antidepressant medication used in the last 2 weeks
- Non-steroid inflammatory drug used in the last 24 hours
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haydarpaşa Numune Education and Research Hospital
Istanbul
About this study
Official title: The Incidence of Fibromyalgia in Patients with OUAS and the Effect of CPAP Treatment on Fibromiyalgia Symptom Severity
-------------Obstructive sleep apnea syndrome (OSAS) is a syndrome characterized by recurrent complete (apnea) or partial (hypopnea) upper respiratory tract obstruction episodes during sleep and a decrease in blood oxygen saturation. It has been suggested that nocturnal arterial desaturation in patients with OSAS is effective on pain. Intermittent hypoxia and oxidative stress occur in patients with OSAS. Intermittent hypoxia occurring in patients with OSAS causes increased levels of HIF-1-α and mitochondrial reactive oxygen products, resulting in the formation, processing, and formation of central and peripheral synthesis. When the literature is examined, pressure-related pain threshold was measured with algometer in female patients diagnosed with sleep apnea and in the control group, and it was found lower in patients with OSAS.
Fibromyalgia Syndrome (FMS) is a clinical picture with many symptoms such as chronic widespread pain, fatigue, sleep disturbance, cognitive dysfunction. Similar sleep patterns were observed in FMS and OSAS.
Read more
In addition to sleep symptoms such as the presence of a similar sleep pattern, a feeling of rest and daytime sleepiness in cases of OSAS and FMS, it has been suggested that these two diseases may be related to each other. Studies examining the relationship between OSAS and FMS syndrome, including sleep disturbance and pain symptoms, are rare in the literature. In the current literature, there are various limitations such as insufficient number of cases, significant difference between demographic characteristics such as gender, ethnicity, age.
Therefore, primary goal of this study is to investigate the association of FMS in patients diagnosed with OSAS. The secondary aim is to investigate the effect of CPAP (Continuous Positive Airway Pressure) treatment on pain sensitivity and symptom severity, functional level, depression in patients diagnosed with FMS, and to investigate the relationship between these parameters and polysomnographic data
Read the detailed description
Patients between 30-65 years of age who were diagnosed with OSAS according to American Academy of Sleep Medicine (AASM) criteria and who had clinical symptoms of OSAS for at least 1 year before diagnosis will be performed. All OSAS patients recommended and not recommended for CPAP treatment in the sleep clinic will be evaluated according to the American Rheumatology Association (ACR) 1990 and 2016 criteria for FMS. Patients meeting both criteria will be accepted as FMS.
Demographic data and polysomnographic data of patients such as age, height, weight, BMI, occupation, educational status (polysomnographic data (AHI, min. O₂ sat, O₂ saturation \<90% elapsed time and percentage, sleep latency, sleep efficacy, REM, nREM1,2,3 polysomnographic data such as times, REM latency, severity of OSAS) will be recorded.
- Conditions
- Fibromyalgia, Primary
- Being tested
- continuous positive airway pressure, Polysomnography
- Keywords
- obstructive sleep apnea
- Medical subject headings
- Fibromyalgia, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous positive airway pressureDevice
continuous positive airway pressure is a form of positive airway pressure ventilator, which applies mild air pressure on a continuous basis to keep the airways continuously open in people who are able to breathe spontaneously on their own, but need help keeping their airway unobstructed
PolysomnographyDevice
Polysomnography measures Apnea-hypopnea index (Minutes)
Classify and identify Obstructive Sleep Apnea Syndrome (OSAS):
- Apnea-hypopnea index: 5-14.9 olan; mild OSAS
- Apnea-hypopnea index: 15-29.9: moderate OSAS
- Apnea-hypopnea index ≥30: severe OSAS measures duration and percentage of time oxygen saturation dropped below 90% the total minutes of sleep
| Study group | Role | What they receive |
|---|---|---|
| 225 patients with obstructive sleep apnea syndrome | Patients with obstructive sleep apnea syndrome recieved CPAP therapy Receives: Device: continuous positive airway pressure; Device: Polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analoge Scale
Mnimum-maximum values: 0-10 Higher scores mean worse outcome for pain scores
Measured: From enrollment to the end of treatment at 12 weeks
Algometer
pain pressure treshold measurements unit: kg/m2 Higher scores mean better outcome
Measured: From enrollment to the end of treatment at 12 weeks
Fibromiyalgia Fatigue Scale Questionnaire
min-max scores:0-72 measures disability Higher scores mean worse outcome
Measured: From enrollment to the end of treatment at 12 weeks
Fibromiyalgia Impact Questionnaire
measures disability level of patients with Fibromyalgia min-max scores: 0-100 Higher scores mean worse outcome
Measured: From enrollment to the end of treatment at 12 weeks"
Secondary outcomes (2)
Epworth Sleepness Scale Questionnaire
measures sleep quality min-max scores: 0-24 score between 16-24 on this scale is considered increased daytime sleepiness
Measured: From enrollment to the end of treatment at 12 weeks
Back Depression Inventory
measures depression level min-max values: 0-63 Higher scores mean worse outcome
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Aug 2018
- Primary completion1 Feb 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia, PrimaryStudies 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
- 225 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Haydarpasa Numune Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duygu Geler Külcü, Haydarpasa Numune Training and Research Hospital
- Investigators
- Nilgün Mesci, assoc prof, Study director, Haydarpaşa Numune education and research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595771
- Sponsor's protocol ID
- FSMEAH-KAEK 2018/37
- Status last verified
- Aug 2018
- First submitted
- 4 Sep 2024
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Fibromyalgia in Patients with OUAS and the Effect of CPAP Treatment on Fibromiyalgia Symptom Severity
- ClinicalTrials.gov ID
- NCT06595771
- Acronym / sponsor ID
- FSMEAH-KAEK 2018/37
- Conditions
- Fibromyalgia, Primary
- Keywords
- obstructive sleep apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Haydarpasa Numune Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 19 Sep 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.
-------------Obstructive sleep apnea syndrome (OSAS) is a syndrome characterized by recurrent complete (apnea) or partial (hypopnea) upper respiratory tract obstruction episodes during sleep and a decrease in blood oxygen saturation. It has been suggested that nocturnal arterial desaturation in patients with OSAS is effective on pain. Intermittent hypoxia and oxidative stress occur in patients with OSAS. Intermittent hypoxia occurring in patients with OSAS causes increased levels of HIF-1-α and mitochondrial reactive oxygen products, resulting in the formation, processing, and formation of central and peripheral synthesis. When the literature is examined, pressure-related pain threshold was measured with algometer in female patients diagnosed with sleep apnea and in the control group, and it was found lower in patients with OSAS.
Fibromyalgia Syndrome (FMS) is a clinical picture with many symptoms such as chronic widespread pain, fatigue, sleep disturbance, cognitive dysfunction. Similar sleep patterns were observed in FMS and OSAS.
In addition to sleep symptoms such as the presence of a similar sleep pattern, a feeling of rest and daytime sleepiness in cases of OSAS and FMS, it has been suggested that these two diseases may be related to each other. Studies examining the relationship between OSAS and FMS syndrome, including sleep disturbance and pain symptoms, are rare in the literature. In the current literature, there are various limitations such as insufficient number of cases, significant difference between demographic characteristics such as gender, ethnicity, age.
Therefore, primary goal of this study is to investigate the association of FMS in patients diagnosed with OSAS. The secondary aim is to investigate the effect of CPAP (Continuous Positive Airway Pressure) treatment on pain sensitivity and symptom severity, functional level, depression in patients diagnosed with FMS, and to investigate the relationship between these parameters and polysomnographic data
Detailed description
Patients between 30-65 years of age who were diagnosed with OSAS according to American Academy of Sleep Medicine (AASM) criteria and who had clinical symptoms of OSAS for at least 1 year before diagnosis will be performed. All OSAS patients recommended and not recommended for CPAP treatment in the sleep clinic will be evaluated according to the American Rheumatology Association (ACR) 1990 and 2016 criteria for FMS. Patients meeting both criteria will be accepted as FMS.
Demographic data and polysomnographic data of patients such as age, height, weight, BMI, occupation, educational status (polysomnographic data (AHI, min. O₂ sat, O₂ saturation \<90% elapsed time and percentage, sleep latency, sleep efficacy, REM, nREM1,2,3 polysomnographic data such as times, REM latency, severity of OSAS) will be recorded.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 225 patients with obstructive sleep apnea syndrome | – | Device: continuous positive airway pressure, Device: PolysomnographyPatients with obstructive sleep apnea syndrome recieved CPAP therapy |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients between 30-65 years of age who were diagnosed with OSAS according to American Academy of Sleep Medicine (AASM) criteria and who had clinical symptoms of OSAS for at least 1 year before diagnosis will be performed. All OSAS patients recommended and not recommended for CPAP treatment in the sleep clinic will be evaluated according to the American Rheumatology Association (ACR) 1990 and 2016 criteria for FMS. Patients meeting both criteria will be accepted as FMS.
Key inclusion criteria (2 listed)
- Being between the ages of 1-30-65
- Being diagnosed with Obstructive Sleep apnea syndrome and/or having CPAP treatment indication
Key exclusion criteria (6 listed)
- Chronic inflammatory or autoimmune disease
- hyperthyroidism/hyperthyroidism
- Cognitive dysfunction (such as dementia)
- Severe psychiatric disorder
- Antidepressant medication used in the last 2 weeks
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 |
|---|---|---|
| continuous positive airway pressurecontinuous positive airway pressure is a form of positive airway pressure ventilator, which applies mild air pressure on a continuous basis to keep the airways continuously open in people who are able to breathe spontaneously on their own, but need help keeping their airway unobstructed | Device | 225 patients with obstructive sleep apnea syndrome |
| PolysomnographyPolysomnography measures Apnea-hypopnea index (Minutes) Classify and identify Obstructive Sleep Apnea Syndrome (OSAS): 1. Apnea-hypopnea index: 5-14.9 olan; mild OSAS 2. Apnea-hypopnea index: 15-29.9: moderate OSAS 3. Apnea-hypopnea index ≥30: severe OSAS measures duration and percentage of time oxygen saturation dropped below 90% the total minutes of sleep | Device | 225 patients with obstructive sleep apnea syndrome |
Primary outcome
Visual Analoge Scale
Time frame: From enrollment to the end of treatment at 12 weeks
Mnimum-maximum values: 0-10 Higher scores mean worse outcome for pain scores
Algometer
Time frame: From enrollment to the end of treatment at 12 weeks
pain pressure treshold measurements unit: kg/m2 Higher scores mean better outcome
Fibromiyalgia Fatigue Scale Questionnaire
Time frame: From enrollment to the end of treatment at 12 weeks
min-max scores:0-72 measures disability Higher scores mean worse outcome
Fibromiyalgia Impact Questionnaire
Time frame: From enrollment to the end of treatment at 12 weeks"
measures disability level of patients with Fibromyalgia min-max scores: 0-100 Higher scores mean worse outcome
2 secondary outcomes
Epworth Sleepness Scale Questionnaire
Time frame: From enrollment to the end of treatment at 12 weeks
Back Depression Inventory
Time frame: From enrollment to the end of treatment at 12 weeks
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 19 Sep 2024.
- 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.
Nilgün Mesci, assoc prof study director
Haydarpaşa Numune education 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 Fibromyalgia, Primary, run by Haydarpasa Numune 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 6 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 19 Sep 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?
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?
Visual Analoge Scale (time frame: From enrollment to the end of treatment at 12 weeks). The study lists 4 primary outcomes in all. 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 19 Sep 2024.