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

NCT05367167 | Completed

• 1 other identifier: 3
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 1

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).

Conditions

Obstructive Sleep Apnea; Fibromyalgia

Keywords

Polysomnography; Obstructive Sleep Apnea; Fibromiyalgia

Outcome Measures

Primary Outcomes (15)

• Fatigue Severity Scale

  "Fatigue Severity Scale" was used to evaluate the fatigue level of the participants. This scale consists of a 7-point Likert scale. 1 point means strongly disagree, 7 means strongly agree. High scores are associated with increased fatigue. Evaluates the effects of fatigue on physical function, motivation, family and social life. Turkish validity and reliability was established.

  0 day (baseline)

• Fibromyalgia Impact Scale

  The fibromyalgia levels of the participants will be evaluated with the Fibromyalgia Impact Scale. High scores indicate increased disease activity. Consists of 10 questions Maximum score is 80. Turkish validity and reliability was done

  0 day (baseline)

• Beck Anxiety and Depression Inventory.

  Anxiety and depression levels will be evaluated with the Beck Anxiety and Depression Inventory. Turkish validity and reliability were done.Beck Depression Inventory (BDI) is a 21-item self-assessment scale that measures characteristic attitudes and symptoms of depression. The application takes about 10 minutes to complete. It is designed for people aged 13 and over. High scores report an increased level of depression.Beck anxiety scale This test, which consists of 21 optional questions, is accepted as an internationally valid tool used to measure the severity of anxiety in individuals.Each item marked on the Beck anxiety scale has a score. None is 0 points, mild 1 point, moderate 2 points, and severe 3 points. In this way, these scores are summed after 21 questions are marked. High scores indicate an increased level of anxiety.

  0 day (baseline)

• visual analog scale

  Pain levels will be evaluated with a visual analog scale. The VAS is a scale that evaluates the severity of pain with the Likert scale. Increased scores indicate severe pain.

  0 day (baseline)

• Algometer.

  The pain threshold of all patients will be measured with an algometer. Measurement with an algometer is not an invasive measurement method. It shows the patient's pain sensitivity numerically according to the applied pressure.

  0 day (baseline)

• Demografic Datas

  Sex, chronic disease, smoking

  0 day (baseline)

• BMI

  64 / 5.000 Çeviri sonuçları Body mass index will be calculated by measuring height (cm), weight (kg),

  0 day (baseline)

• Polisomnografi - SLEEP LATENCE

  Sleep latency time will be measured in polysomnography

  0 day (baseline)

• Polisomnografi -SLEEP ACTIVITY

  Sleep efficiency will be measured during polysomnography

  0 day (baseline)

• Polisomnografi -REM time

  REM time will be measured in minutes during polysomnography

  0 day (baseline)

• Polisomnografi -NREM STAGES

  During polysomnography, NREM stages will be measured at 1 min, 2 min, and 3 min.

  0 day (baseline)

• Polisomnografi - NUMBERS OF APNE

  Numbers of apnea will be recorded in polysomnographic measurements.

  0 day (baseline)

• Polisomnografi -NUMBER OF HYPOPNEA

  Numbers of hypopnea will be recorded in polysomnographic measurements.

  0 day (baseline)

• Polisomnografi -Apnea hypopnea index (AHI) REM, NONREM in polysomnography; Apnea hypopnea index (AHI) will be evaluated on a supine, non-supine basis.

  Apnea hypopnea index (AHI) will be evaluated as REM, NONREM, Supine, non-supine in polysomnography.According to the AHI level; It will be classified as SIMPLE SNORING (AHİ\<5), LIGHT OSAS (AHİ 5-15), MEDIUM OSAS (AHİ 15-30), HEAVY OSAS (AHİ 30+ )

  0 day (baseline)

• Polisomnografi -OXYGEN DESATURATION INDEX

  Minimum oxygen saturation and average oxygen saturation will be measured in polysomnography.

  0 day (baseline)

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

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

You may not qualify if:

• Pregnancy
• Neuropsychiatric disease
• Inflammatory Rheumatic Diseases
• Morbid obesity
• Using a device with a previous diagnosis of OSAS

Sponsors & Collaborators

• Kirsehir Ahi Evran Universitesi: lead

Study Sites (1)

Ahi Evran University

Kırşehir, City Centre, 40100, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 31118843 BACKGROUND

• 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.

  PMID: 29404158 BACKGROUND

• 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.

  PMID: 32601643 BACKGROUND

• 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.

  PMID: 37071285 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Fibromyalgia

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases

Study Officials

• Basak Cigdem Karacay, Asisst Prof

  Kirsehir Ahi Evran Universitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: May 10, 2022
• Study Start: April 8, 2022
• Primary Completion: November 28, 2022
• Study Completion: November 28, 2022
• Last Updated: January 3, 2023

Record last verified: 2022-12

Locations

TU (1)