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

NCT06536894 | Completed

• 1 other identifier: KAEK_2024-12/95
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia Syndrome; Obstructive Sleep Apnea Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (13)

• 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.

  Day 0 ( Baseline)

• Polisomnografi- SLEEP LATENCE

  Sleep latency time will be measured in polysomnography

  Day 0 ( Baseline)

• Polisomnografi -SLEEP ACTIVITY

  Sleep efficiency will be measured during polysomnography

  Day 0 ( Baseline)

• Polisomnografi -REM time

  REM time will be measured in minutes during polysomnography

  Day 0 ( Baseline)

• Polisomnografi -NREM STAGES

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

  Day 0 ( Baseline)

• Polisomnografi - NUMBERS OF APNE

  Numbers of apnea will be recorded in polysomnographic measurements.

  Day 0 ( Baseline)

• Polisomnografi -NUMBER OF HYPOPNEA

  Numbers of hypopnea will be recorded in polysomnographic measurements

  Day 0 ( Baseline)

• 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+ )

  Day 0 ( Baseline)

• Polisomnografi-REM

  REM times will be evaluated in polysomnography

  Day 0 ( Baseline)

• Polisomnografi-NonREM

  NonREM times will be evaluated in polysomnography

  Day 0 ( Baseline)

• 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+ )

  Day 0 ( Baseline)

• Polisomnografi -OXYGEN DESATURATION INDEX

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

  Day 0 ( Baseline)

• submental ultrasonography

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

  Day 0 ( Baseline)

Secondary Outcomes (2)

• Pittsburgh Sleep Quality Index

  Day 0 ( Baseline)

• Fibromyalgia Impact Scale

  Day 0 ( Baseline)

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: In order to eliminate gender-based factors
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kirsehir Ahi Evran Universitesi: lead

Study Sites (1)

Ahi evran university

Kırşehir, Kırşehir, 40100, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 32601643 BACKGROUND

• 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.

  PMID: 37071285 BACKGROUND

• 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.

  PMID: 35871215 BACKGROUND

• 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.

  PMID: 37735660 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia; Sleep Apnea, Obstructive; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Basak Cigdem Karacay, Assoc. Prof

  Kirsehir Ahi Evran Universitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assosc Prof

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: August 5, 2024
• Study Start: August 5, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

TU (1)