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

NCT ID: NCT06536894

Last Updated: 2024-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fibromyalgia Syndrome Obstructive Sleep Apnea Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fibromyalgia syndrome and obstructive sleep apnea

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

No interventions assigned to this group

Fibromyalgia syndrome

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

No interventions assigned to this group

Obstructive sleep apnea syndrome.

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kirsehir Ahi Evran Universitesi

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Basak Cigdem Karacay

Assosc Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Basak Cigdem Karacay, Assoc. Prof

Role: PRINCIPAL_INVESTIGATOR

Kirsehir Ahi Evran Universitesi

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Basak Cigdem Karacay, Assoc. Prof.

Role: CONTACT

+905445094803

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 32601643 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37071285 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35871215 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37735660 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KAEK_2024-12/95

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Sleep Apnea, Obesity and Pregnancy
NCT02029859 COMPLETED NA