Clinical trial NCT06595771: Obstructive Sleep Apnea Syndrome and Fibromiyalgia
Official title: The Incidence of Fibromyalgia in Patients with OUAS and the Effect of CPAP Treatment on Fibromiyalgia Symptom Severity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibromyalgia, Primary
Keywords: obstructive sleep apnea
Lead sponsor: Haydarpasa Numune Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 225
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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 \&amp;lt;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.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 1-30-65
* Being diagnosed with Obstructive Sleep apnea syndrome and/or having CPAP treatment indication

Exclusion Criteria:

* 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

Primary outcomes:
measure: Visual Analoge Scale
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Algometer
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Fibromiyalgia Fatigue Scale Questionnaire
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Fibromiyalgia Impact Questionnaire
timeFrame: From enrollment to the end of treatment at 12 weeks&amp;amp;#34;
Secondary outcomes:
measure: Epworth Sleepness Scale Questionnaire
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Back Depression Inventory
timeFrame: From enrollment to the end of treatment at 12 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Haydarpaşa Numune Education and Research Hospital
Study officials:
affiliation: Haydarpaşa Numune education and research Hospital
name: Nilgün Mesci, assoc prof
role: STUDY_DIRECTOR
References: