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Fibromyalgia SyndromeNCT06536894

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

An observational study of Fibromyalgia Syndrome and Obstructive Sleep Apnea Syndrome, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years, women only
How many people
77 participants
Where
1 siteTurkey (Türkiye)
Study dates
5 Aug 2024to 1 Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Ahi evran university

    Kırşehir, 40100

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of the Presence 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.

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.

Keywords
Sleep Disorder, Obstructive Sleep Apnea Syndrome, Fibromyalgia Syndrome, anthropometric measurement, ultrasonographic measurement, Polysomnography
Medical subject headings
Fibromyalgia, Sleep Apnea, Obstructive, Sleep Wake Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06536894
Study groupRoleWhat they receive
Fibromyalgia syndrome and obstructive sleep apneaFibromyalgia patients who were diagnosed with OSAS as a result of polysomnographic examination
Fibromyalgia syndromeFibromyalgia 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 0 ( Baseline)

  2. Polisomnografi- SLEEP LATENCE

    Sleep latency time will be measured in polysomnography

    Measured: Day 0 ( Baseline)

  3. Polisomnografi -SLEEP ACTIVITY

    Sleep efficiency will be measured during polysomnography

    Measured: Day 0 ( Baseline)

  4. Polisomnografi -REM time

    REM time will be measured in minutes during polysomnography

    Measured: Day 0 ( Baseline)

  5. Polisomnografi -NREM STAGES

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

    Measured: Day 0 ( Baseline)

  6. Polisomnografi - NUMBERS OF APNE

    Numbers of apnea will be recorded in polysomnographic measurements.

    Measured: Day 0 ( Baseline)

  7. Polisomnografi -NUMBER OF HYPOPNEA

    Numbers of hypopnea will be recorded in polysomnographic measurements

    Measured: 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+ )

    Measured: Day 0 ( Baseline)

  9. Polisomnografi-REM

    REM times will be evaluated in polysomnography

    Measured: Day 0 ( Baseline)

  10. Polisomnografi-NonREM

    NonREM times will be evaluated in polysomnography

    Measured: 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+ )

    Measured: Day 0 ( Baseline)

  12. Polisomnografi -OXYGEN DESATURATION INDEX

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

    Measured: Day 0 ( Baseline)

  13. submental ultrasonography

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

    Measured: Day 0 ( Baseline)

Secondary outcomes (2)

  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.

    Measured: 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

    Measured: Day 0 ( Baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2024
  2. Study start5 Aug 2024
  3. Primary completion1 Dec 2025
  4. Study completion1 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06536894
Sponsor's protocol ID
KAEK_2024-12/95
Status last verified
Aug 2026
First submitted
11 Jul 2024
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

An observational study of Fibromyalgia Syndrome and Obstructive Sleep Apnea Syndrome, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anthropometric Measurements (time frame: Day 0 ( Baseline)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06536894, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.

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