Clinical trial NCT06536894: Fibromyalgia Syndrome on Anthropometric and Ultrasonographic Measurements in Obstructive Sleep Apnea Syndrome
Official title: The Effect of the Presence Fibromyalgia Syndrome on Anthropometric and Ultrasonographic Measurements in Obstructive Sleep Apnea Syndrome
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Fibromyalgia Syndrome
Obstructive Sleep Apnea Syndrome
Keywords: Sleep Disorder
Obstructive Sleep Apnea Syndrome
Fibromyalgia Syndrome
anthropometric measurement
ultrasonographic measurement
Polysomnography
Lead sponsor: Kirsehir Ahi Evran Universitesi
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Anthropometric Measurements
timeFrame: Day 0 ( Baseline)
measure: Polisomnografi- SLEEP LATENCE
timeFrame: Day 0 ( Baseline)
measure: Polisomnografi -SLEEP ACTIVITY
timeFrame: Day 0 ( Baseline)
measure: Polisomnografi -REM time
timeFrame: Day 0 ( Baseline)
measure: Polisomnografi -NREM STAGES
timeFrame: Day 0 ( Baseline)
measure: Polisomnografi - NUMBERS OF APNE
timeFrame: Day 0 ( Baseline)
measure: Polisomnografi -NUMBER OF HYPOPNEA
timeFrame: Day 0 ( Baseline)
measure: Polisomnografi -Apnea hypopnea index (AHI) in polysomnography; Apnea hypopnea index (AHI) will be evaluated on a supine, non-supine basis.
timeFrame: Day 0 ( Baseline)
measure: Polisomnografi-REM
timeFrame: Day 0 ( Baseline)
measure: Polisomnografi-NonREM
timeFrame: Day 0 ( Baseline)
measure: Polisomnografi -Apnea hypopnea index (AHI) REM, NONREM in polysomnography; Apnea hypopnea index (AHI) will be evaluated on a supine, non-supine basis.
timeFrame: Day 0 ( Baseline)
measure: Polisomnografi -OXYGEN DESATURATION INDEX
timeFrame: Day 0 ( Baseline)
measure: submental ultrasonography
timeFrame: Day 0 ( Baseline)
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: Day 0 ( Baseline)
measure: Fibromyalgia Impact Scale
timeFrame: Day 0 ( Baseline)
Other outcomes:
Locations:
Study officials:
affiliation: Kirsehir Ahi Evran Universitesi
name: Basak Cigdem Karacay, Assoc. Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.