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NCT Number: NCT06536894

Fibromyalgia Syndrome on Anthropometric and Ultrasonographic Measurements in Obstructive Sleep Apnea Syndrome

Obstructive type sleep apnea syndrome is a clinical condition characterized by apnea, hypopnea and oxygen desaturation due to narrowing of the upper airway during sleep. Obesity is considered a major predisposing factor for OSAS. In addition, various recent studies have reported that various anthropometric measurements such as neck circumference, waist circumference, hip circumference, waist-hip ratio, neck-waist circumference ratio change (increase) in OSAS patients.

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Key information

Conditions

Fibromyalgia Syndrome Apnea Dyssomnias Fibromyalgia Mental Disorders Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Obstructive Sleep Apnea Syndrome Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Rheumatic Diseases Signs and Symptoms Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Ahi evran university

Kırşehir, 40100, Turkey (Türkiye)

About this study

Fibromyalgia is a common health problem that is characterized by pain in various parts of the body and is very difficult to diagnose and treat. It affects 2-4% of the population and is more common in women. The presence of OSAS in fibromyalgia patients is more common than in the normal population. There are also common additional symptoms such as excessive daytime sleepiness and delayed sleep latency.

Although it has been reported that the presence of OSAS is more common in fibromyalgia patients, there is no study on the presence of anthropometric measurements, especially neck circumference, that are accepted in OSAS.

The aim of this study is to compare the anthropometric and ultrasonographic measurements of female OSAS patients with and without fibromyalgia.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Between 18-65 years old
  • Being diagnosed with fibromyalgia and having applied to the sleep disorders outpatient clinic or being followed up with the diagnosis of OSAS in the sleep disorders outpatient clinic.
  • Agree to participate in the study

Exclusion criteria

  • Patients under 18 years of age
  • Male patients
  • Not agreeing to participate in the study
  • Neurological diseases that may cause OSAS such as stroke, Parkinson's disease, multiple sclerosis
  • Rheumatological, oncological and hematological diseases
  • Central type obstructive sleep apnea syndrome
  • Thyroid pathology that affects neck circumference measurement

Treatment and study plan

Primary outcomes

  1. Anthropometric Measurements

    Time frame: Day 0 ( Baseline)

    Anthropometric measurements will be taken for all patients. These measurements include neck circumference, waist circumference, hip circumference, and with these data, waist-hip ratio and neck-waist circumference ratio will be calculated. Measurements will be made with a tape measure and with patient consent.

  2. Polisomnografi- SLEEP LATENCE

    Time frame: Day 0 ( Baseline)

    Sleep latency time will be measured in polysomnography

  3. Polisomnografi -SLEEP ACTIVITY

    Time frame: Day 0 ( Baseline)

    Sleep efficiency will be measured during polysomnography

  4. Polisomnografi -REM time

    Time frame: Day 0 ( Baseline)

    REM time will be measured in minutes during polysomnography

  5. Polisomnografi -NREM STAGES

    Time frame: Day 0 ( Baseline)

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

  6. Polisomnografi - NUMBERS OF APNE

    Time frame: Day 0 ( Baseline)

    Numbers of apnea will be recorded in polysomnographic measurements.

  7. Polisomnografi -NUMBER OF HYPOPNEA

    Time frame: Day 0 ( Baseline)

    Numbers of hypopnea will be recorded in polysomnographic measurements

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

    Time frame: Day 0 ( Baseline)

    Apnea hypopnea index (AHI) will be evaluated 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+ )

  9. Polisomnografi-REM

    Time frame: Day 0 ( Baseline)

    REM times will be evaluated in polysomnography

  10. Polisomnografi-NonREM

    Time frame: Day 0 ( Baseline)

    NonREM times will be evaluated in polysomnography

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

    Time frame: Day 0 ( 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+ )

  12. Polisomnografi -OXYGEN DESATURATION INDEX

    Time frame: Day 0 ( Baseline)

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

  13. submental ultrasonography

    Time frame: Day 0 ( Baseline)

    All patients will undergo submental ultrasonography to measure tongue base thickness and lateral pharyngeal wall thickness.

Secondary outcomes

  1. Pittsburgh Sleep Quality Index

    Time frame: Day 0 ( Baseline)

    The Pittsburgh Sleep Quality Index will be used to evaluate sleep quality. The survey consists of 21 questions and a high score indicates poor sleep quality.

  2. Fibromyalgia Impact Scale

    Time frame: Day 0 ( 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

Sponsors and collaborators

Lead sponsor

Kirsehir Ahi Evran Universitesi

Other

Registry information

Official study title

The Effect of the Presence Fibromyalgia Syndrome on Anthropometric and Ultrasonographic Measurements in Obstructive Sleep Apnea Syndrome

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 5, 2024
Registry last updated
Mar 31, 2026

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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