The Effect of Fibromyalgia Syndrome Accompanying Obstructive Sleep Apnea Syndrome on Clinical Findings

NCT ID: NCT05367167

Last Updated: 2023-01-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 69 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-08
• Study Completion Date: 2022-11-28

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.

Conditions

Obstructive Sleep Apnea; Fibromyalgia

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Case group

Patients who meet the 2010 American College of Rheumatology diagnostic criteria and were diagnosed with OSAS in the sleep laboratory will be considered as the case group.

No interventions assigned to this group

Control group

Patients who did not meet the 2010 American College of Rheumatology diagnostic criteria and were diagnosed with OSAS in the sleep laboratory will be considered as the control group.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kirsehir Ahi Evran Universitesi

OTHER

Sponsor Role: lead

Responsible Party

Basak Cigdem Karacay

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Basak Cigdem Karacay, Asisst Prof

Role: PRINCIPAL_INVESTIGATOR

Kirsehir Ahi Evran Universitesi

Locations

Ahi Evran University

Kırşehir, City Centre, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 31118843 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29404158 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32601643 (View on PubMed)

Cigdem Karacay B, Sahbaz T, Zerman N, Tuncay F. The impact of fibromyalgia syndrome on obstructive sleep apnea syndrome in terms of pain threshold, daytime symptoms, anxiety, depression, disease severity, and sleep quality: a polysomnographic study. Sleep Breath. 2023 Aug;27(4):1473-1479. doi: 10.1007/s11325-023-02831-2. Epub 2023 Apr 18.

Reference Type: DERIVED

PMID: 37071285 (View on PubMed)

Other Identifiers

3

Identifier Type: -

Identifier Source: org_study_id