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CompletedNCT06536894Updated Aug 10, 2026

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

An observational study in Fibromyalgia Syndrome and Obstructive Sleep Apnea Syndrome, sponsored by Kirsehir Ahi Evran Universitesi. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-10.

Sponsored by Kirsehir Ahi Evran Universitesi · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
77
Ages
18 Years to 80 Years
Sex
Female
01

Study summary

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.

Read the detailed description

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.

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Conditions studied

  • Fibromyalgia Syndrome
  • Obstructive Sleep Apnea Syndrome

Keywords

  • Sleep Disorder
  • Obstructive Sleep Apnea Syndrome
  • Fibromyalgia Syndrome
  • anthropometric measurement
  • ultrasonographic measurement
  • Polysomnography
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In context

Fibromyalgia

1,338 studies on the registry are indexed under Fibromyalgia; 268 are open to participants now.

This study's enrollment of 77 is below the median of 100 across 270 observational studies indexed under Fibromyalgia.

Browse Fibromyalgia studies →

Lead sponsor

Kirsehir Ahi Evran Universitesi is the lead sponsor of 133 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Female patients diagnosed with fibromyalgia who applied to the sleep disorders outpatient clinic operating within the Department of Neurology and underwent polysomnography with sleep problems, as well as patients diagnosed with OSAS, will be included.

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

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
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Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
77 participants (actual)
Patient registry
No

Groups and cohorts

  • Fibromyalgia syndrome and obstructive sleep apnea

    Fibromyalgia patients who were diagnosed with OSAS as a result of polysomnographic examination

  • Fibromyalgia syndrome

    Fibromyalgia patients who were not diagnosed with OSAS as a result of polysomnographic examination

  • Obstructive sleep apnea syndrome.

    Patients diagnosed with OSAS as a result of polysomnographic examination and without fibromyalgia

06

What researchers measure

Primary outcomes

  1. Anthropometric Measurements

    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.

    Time frame: Day 0 ( Baseline)

  2. Polisomnografi- SLEEP LATENCE

    Sleep latency time will be measured in polysomnography

    Time frame: Day 0 ( Baseline)

  3. Polisomnografi -SLEEP ACTIVITY

    Sleep efficiency will be measured during polysomnography

    Time frame: Day 0 ( Baseline)

  4. Polisomnografi -REM time

    REM time will be measured in minutes during polysomnography

    Time frame: Day 0 ( Baseline)

  5. Polisomnografi -NREM STAGES

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

    Time frame: Day 0 ( Baseline)

  6. Polisomnografi - NUMBERS OF APNE

    Numbers of apnea will be recorded in polysomnographic measurements.

    Time frame: Day 0 ( Baseline)

  7. Polisomnografi -NUMBER OF HYPOPNEA

    Numbers of hypopnea will be recorded in polysomnographic measurements

    Time frame: Day 0 ( Baseline)

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

    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+ )

    Time frame: Day 0 ( Baseline)

  9. Polisomnografi-REM

    REM times will be evaluated in polysomnography

    Time frame: Day 0 ( Baseline)

  10. Polisomnografi-NonREM

    NonREM times will be evaluated in polysomnography

    Time frame: Day 0 ( Baseline)

  11. 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+ )

    Time frame: Day 0 ( Baseline)

  12. Polisomnografi -OXYGEN DESATURATION INDEX

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

    Time frame: Day 0 ( Baseline)

  13. submental ultrasonography

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

    Time frame: Day 0 ( Baseline)

Secondary outcomes

  1. Pittsburgh Sleep Quality Index

    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.

    Time frame: Day 0 ( Baseline)

  2. 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

    Time frame: Day 0 ( Baseline)

07

Study locations

1 site
  • Ahi evran university
    Kırşehir, 40100, Turkey (Türkiye)
08

References and documents

Publications

  • 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. PubMed 32601643 ↗
  • 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. PubMed 37071285 ↗
  • Mohan Lal B, Vyas S, Malhotra A, Ray A, Gupta G, Pandey S, Pandey RM, Aggarwal S, Sinha S. Ultrasonography of the neck in patients with obstructive sleep apnea. Sleep Breath. 2023 Jun;27(3):903-912. doi: 10.1007/s11325-022-02682-3. Epub 2022 Jul 23. PubMed 35871215 ↗
  • Deng H, Duan X, Huang J, Zheng M, Lao M, Weng F, Su QY, Zheng ZF, Mei Y, Huang L, Yang WH, Xing X, Ma X, Zhao W, Liu X. Association of adiposity with risk of obstructive sleep apnea: a population-based study. BMC Public Health. 2023 Sep 21;23(1):1835. doi: 10.1186/s12889-023-16695-4. PubMed 37735660 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06536894
Lead sponsor
Kirsehir Ahi Evran Universitesi
Responsible party
Basak Cigdem Karacay (Assosc Prof, Kirsehir Ahi Evran Universitesi) — Principal investigator
First posted
Aug 5, 2024
Start date
Aug 5, 2024
Primary completion
Dec 1, 2025
Completion
Dec 1, 2025
Last update
Aug 10, 2026

Study contacts

Basak Cigdem Karacay, Assoc. Prof
principal investigator · Kirsehir Ahi Evran Universitesi

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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