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Completed

NCT Number: NCT05367167

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

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).

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ahi Evran University

Kırşehir, City Centre, 40100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Fatigue Severity Scale

    Time frame: 0 day (baseline)

    "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.

  2. Fibromyalgia Impact Scale

    Time frame: 0 day (baseline)

    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

  3. Beck Anxiety and Depression Inventory.

    Time frame: 0 day (baseline)

    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.

  4. visual analog scale

    Time frame: 0 day (baseline)

    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.

  5. Algometer.

    Time frame: 0 day (baseline)

    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.

  6. Demografic Datas

    Time frame: 0 day (baseline)

    Sex, chronic disease, smoking

  7. BMI

    Time frame: 0 day (baseline)

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

  8. Polisomnografi - SLEEP LATENCE

    Time frame: 0 day (baseline)

    Sleep latency time will be measured in polysomnography

  9. Polisomnografi -SLEEP ACTIVITY

    Time frame: 0 day (baseline)

    Sleep efficiency will be measured during polysomnography

  10. Polisomnografi -REM time

    Time frame: 0 day (baseline)

    REM time will be measured in minutes during polysomnography

  11. Polisomnografi -NREM STAGES

    Time frame: 0 day (baseline)

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

  12. Polisomnografi - NUMBERS OF APNE

    Time frame: 0 day (baseline)

    Numbers of apnea will be recorded in polysomnographic measurements.

  13. Polisomnografi -NUMBER OF HYPOPNEA

    Time frame: 0 day (baseline)

    Numbers of hypopnea will be recorded in polysomnographic measurements.

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

    Time frame: 0 day (baseline)

    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+ )

  15. Polisomnografi -OXYGEN DESATURATION INDEX

    Time frame: 0 day (baseline)

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

Sponsors and collaborators

Lead sponsor

Kirsehir Ahi Evran Universitesi

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 10, 2022
Registry last updated
Jan 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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