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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06536894
Enrollment
77
Registered
2024-08-05
Start date
2024-08-05
Completion date
2025-12-01
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia Syndrome, Obstructive Sleep Apnea Syndrome

Keywords

Sleep Disorder, Obstructive Sleep Apnea Syndrome, Fibromyalgia Syndrome, anthropometric measurement, ultrasonographic measurement, Polysomnography

Brief 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.

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.

Interventions

None listed

Sponsors

Kirsehir Ahi Evran Universitesi
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Anthropometric MeasurementsDay 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.
Polisomnografi- SLEEP LATENCEDay 0 ( Baseline)Sleep latency time will be measured in polysomnography
Polisomnografi -SLEEP ACTIVITYDay 0 ( Baseline)Sleep efficiency will be measured during polysomnography
Polisomnografi -REM timeDay 0 ( Baseline)REM time will be measured in minutes during polysomnography
Polisomnografi -NREM STAGESDay 0 ( Baseline)During polysomnography, NREM stages will be measured at 1 min, 2 min, and 3 min.
Polisomnografi - NUMBERS OF APNEDay 0 ( Baseline)Numbers of apnea will be recorded in polysomnographic measurements.
Polisomnografi -NUMBER OF HYPOPNEADay 0 ( Baseline)Numbers of hypopnea will be recorded in polysomnographic measurements
Polisomnografi -Apnea hypopnea index (AHI) in polysomnography; Apnea hypopnea index (AHI) will be evaluated on a supine, non-supine basis.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+ )
Polisomnografi-REMDay 0 ( Baseline)REM times will be evaluated in polysomnography
Polisomnografi-NonREMDay 0 ( Baseline)NonREM times will be evaluated in polysomnography
Polisomnografi -Apnea hypopnea index (AHI) REM, NONREM in polysomnography; Apnea hypopnea index (AHI) will be evaluated on a supine, non-supine basis.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+ )
Polisomnografi -OXYGEN DESATURATION INDEXDay 0 ( Baseline)Minimum oxygen saturation and average oxygen saturation will be measured in polysomnography.
submental ultrasonographyDay 0 ( Baseline)All patients will undergo submental ultrasonography to measure tongue base thickness and lateral pharyngeal wall thickness.

Secondary

MeasureTime frameDescription
Pittsburgh Sleep Quality IndexDay 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.
Fibromyalgia Impact ScaleDay 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

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORBasak Cigdem Karacay, Assoc. Prof

Kirsehir Ahi Evran Universitesi

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 11, 2026