Clinical trial NCT05367167: The Effect of Fibromyalgia Syndrome Accompanying Obstructive Sleep Apnea Syndrome on Clinical Findings
Official title: The Effect of Fibromyalgia Syndrome Accompanying Obstructive Sleep Apnea Syndrome on Clinical Findings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Fibromyalgia
Keywords: Polysomnography
Obstructive Sleep Apnea
Fibromiyalgia
Lead sponsor: Kirsehir Ahi Evran Universitesi
Sponsor class: OTHER
First posted: 2022-05-10
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Our research will be carried out in patients diagnosed with OSAS after being evaluated in the sleep laboratory of the Kırşehir EAH Department of Chest Diseases. Fibromyalgia screening will be performed on participants who are diagnosed with OSAS and accepted to participate in the study. Patients who were diagnosed with FM according to the 2010 American College of Rheumatology diagnostic criteria will be divided into two groups as FM patients (case group) and patients who do not meet these criteria will be divided into two groups as FM (control group).

Brief summary: Fibromyalgia Syndrome (FMS) is a chronic disease that lasts for at least three months and is characterized by various symptoms such as tender points, widespread pain in the musculoskeletal system, sleep disturbance and fatigue. Obstructive sleep apnea (OSAS) is a disease characterized by repeated upper airway obstruction during sleep. Sleep disorders negatively affect the lives of individuals. The prevalence of OSAS is between 1-5% in studies and it is more common in men than in women. Fatigue, anxiety, depression and sleep disturbance are also common in patients with fibromyalgia. Likewise, the presence of symptoms such as musculoskeletal pain in patients with OSAS suggests that these two diseases may be related to each other. We planned this study to show the relationship between OSAS and fibromyalgia (FM).

Detailed description: Our research will be carried out on patients diagnosed with OSAS after being evaluated in the sleep laboratory of the Research Hospital Department of Chest Diseases. Fibromyalgia screening will be performed on participants who are diagnosed with OSAS and accepted to participate in the study. Patients with FM according to the 2010 American College of Rheumatology diagnostic criteria will be divided into two groups as FM patients (case group) and patients who do not meet these criteria (control group). Sleep laboratory results and demographic data of all patients will be recorded. In addition, anxiety, depression and fatigue levels will be evaluated with scales. Fibromyalgia impact questionnaire will be applied to fibromyalgia patients. Our study is a cross-sectional prospective case-control study. It is not a treatment research, an interventional application will not be made to the patients.

Our hypothesis is that OSAS patients with FMS may have more fatigue, anxiety, depression, lower algometer values, and more severe OSAS findings in polysomnographic data.

Eligibility criteria: Inclusion Criteria:

1.18-60 years old 2. Diagnosed with OSAS in sleep laboratory examinations 3. Agree to participate in the study

Exclusion Criteria:

1. Pregnancy
2. Neuropsychiatric disease
3. Inflammatory Rheumatic Diseases
4. Morbid obesity
5. Using a device with a previous diagnosis of OSAS

Primary outcomes:
measure: Fatigue Severity Scale
timeFrame: 0 day (baseline)
measure: Fibromyalgia Impact Scale
timeFrame: 0 day (baseline)
measure: Beck Anxiety and Depression Inventory.
timeFrame: 0 day (baseline)
measure: visual analog scale
timeFrame: 0 day (baseline)
measure: Algometer.
timeFrame: 0 day (baseline)
measure: Demografic Datas
timeFrame: 0 day (baseline)
measure: BMI
timeFrame: 0 day (baseline)
measure: Polisomnografi - SLEEP LATENCE
timeFrame: 0 day (baseline)
measure: Polisomnografi -SLEEP ACTIVITY
timeFrame: 0 day (baseline)
measure: Polisomnografi -REM time
timeFrame: 0 day (baseline)
measure: Polisomnografi -NREM STAGES
timeFrame: 0 day (baseline)
measure: Polisomnografi - NUMBERS OF APNE
timeFrame: 0 day (baseline)
measure: Polisomnografi -NUMBER OF HYPOPNEA
timeFrame: 0 day (baseline)
measure: Polisomnografi -Apnea hypopnea index (AHI) REM, NONREM in polysomnography; Apnea hypopnea index (AHI) will be evaluated on a supine, non-supine basis.
timeFrame: 0 day (baseline)
measure: Polisomnografi -OXYGEN DESATURATION INDEX
timeFrame: 0 day (baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: Kırşehir
country: Turkey
facility: Ahi Evran University
state: City Centre
Study officials:
affiliation: Kirsehir Ahi Evran Universitesi
name: Basak Cigdem Karacay, Asisst Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meresh ES, Artin H, Joyce C, Birch S, Daniels D, Owens JH, La Rosa AJ, Rao MS, Halaris A. Obstructive sleep apnea co-morbidity in patients with fibromyalgia: a single-center retrospective analysis and literature review. Open Access Rheumatol. 2019 Apr 29;11:103-109. doi: 10.2147/OARRR.S196576. eCollection 2019.
citation: Koseoglu HI, Inanir A, Kanbay A, Okan S, Demir O, Cecen O, Inanir S. Is There a Link Between Obstructive Sleep Apnea Syndrome and Fibromyalgia Syndrome? Turk Thorac J. 2017 Apr;18(2):40-46. doi: 10.5152/TurkThoracJ.2017.16036. Epub 2017 May 1.
citation: Mutlu P, Zateri C, Zohra A, Ozerdogan O, Mirici AN. Prevalence of obstructive sleep apnea in female patients with fibromyalgia. Saudi Med J. 2020 Jul;41(7):740-745. doi: 10.15537/smj.2020.7.25165.