Obstructive Sleep Apnea Syndrome and Fibromiyalgia

NCT ID: NCT06595771

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 225 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2019-02-01

Brief Summary

-------------Obstructive sleep apnea syndrome (OSAS) is a syndrome characterized by recurrent complete (apnea) or partial (hypopnea) upper respiratory tract obstruction episodes during sleep and a decrease in blood oxygen saturation. It has been suggested that nocturnal arterial desaturation in patients with OSAS is effective on pain. Intermittent hypoxia and oxidative stress occur in patients with OSAS. Intermittent hypoxia occurring in patients with OSAS causes increased levels of HIF-1-α and mitochondrial reactive oxygen products, resulting in the formation, processing, and formation of central and peripheral synthesis. When the literature is examined, pressure-related pain threshold was measured with algometer in female patients diagnosed with sleep apnea and in the control group, and it was found lower in patients with OSAS.

Fibromyalgia Syndrome (FMS) is a clinical picture with many symptoms such as chronic widespread pain, fatigue, sleep disturbance, cognitive dysfunction. Similar sleep patterns were observed in FMS and OSAS.

In addition to sleep symptoms such as the presence of a similar sleep pattern, a feeling of rest and daytime sleepiness in cases of OSAS and FMS, it has been suggested that these two diseases may be related to each other. Studies examining the relationship between OSAS and FMS syndrome, including sleep disturbance and pain symptoms, are rare in the literature. In the current literature, there are various limitations such as insufficient number of cases, significant difference between demographic characteristics such as gender, ethnicity, age.

Therefore, primary goal of this study is to investigate the association of FMS in patients diagnosed with OSAS. The secondary aim is to investigate the effect of CPAP (Continuous Positive Airway Pressure) treatment on pain sensitivity and symptom severity, functional level, depression in patients diagnosed with FMS, and to investigate the relationship between these parameters and polysomnographic data

Detailed Description

Patients between 30-65 years of age who were diagnosed with OSAS according to American Academy of Sleep Medicine (AASM) criteria and who had clinical symptoms of OSAS for at least 1 year before diagnosis will be performed. All OSAS patients recommended and not recommended for CPAP treatment in the sleep clinic will be evaluated according to the American Rheumatology Association (ACR) 1990 and 2016 criteria for FMS. Patients meeting both criteria will be accepted as FMS.

Demographic data and polysomnographic data of patients such as age, height, weight, BMI, occupation, educational status (polysomnographic data (AHI, min. O₂ sat, O₂ saturation <90% elapsed time and percentage, sleep latency, sleep efficacy, REM, nREM1,2,3 polysomnographic data such as times, REM latency, severity of OSAS) will be recorded.

Conditions

Fibromyalgia, Primary

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

225 patients with obstructive sleep apnea syndrome

Patients with obstructive sleep apnea syndrome recieved CPAP therapy

continuous positive airway pressure

Intervention Type: DEVICE

continuous positive airway pressure is a form of positive airway pressure ventilator, which applies mild air pressure on a continuous basis to keep the airways continuously open in people who are able to breathe spontaneously on their own, but need help keeping their airway unobstructed

Polysomnography

Intervention Type: DEVICE

Polysomnography measures Apnea-hypopnea index (Minutes)

Classify and identify Obstructive Sleep Apnea Syndrome (OSAS):

1. Apnea-hypopnea index: 5-14.9 olan; mild OSAS

2. Apnea-hypopnea index: 15-29.9: moderate OSAS

3. Apnea-hypopnea index ≥30: severe OSAS measures duration and percentage of time oxygen saturation dropped below 90% the total minutes of sleep

Interventions

continuous positive airway pressure

continuous positive airway pressure is a form of positive airway pressure ventilator, which applies mild air pressure on a continuous basis to keep the airways continuously open in people who are able to breathe spontaneously on their own, but need help keeping their airway unobstructed

Intervention Type: DEVICE

Polysomnography

Polysomnography measures Apnea-hypopnea index (Minutes)

Classify and identify Obstructive Sleep Apnea Syndrome (OSAS):

1. Apnea-hypopnea index: 5-14.9 olan; mild OSAS

2. Apnea-hypopnea index: 15-29.9: moderate OSAS

3. Apnea-hypopnea index ≥30: severe OSAS measures duration and percentage of time oxygen saturation dropped below 90% the total minutes of sleep

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Being between the ages of 1-30-65
• Being diagnosed with Obstructive Sleep apnea syndrome and/or having CPAP treatment indication

Exclusion Criteria

• Chronic inflammatory or autoimmune disease
• hyperthyroidism/hyperthyroidism
• Cognitive dysfunction (such as dementia)
• Severe psychiatric disorder
• Antidepressant medication used in the last 2 weeks
• Non-steroid inflammatory drug used in the last 24 hours

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haydarpasa Numune Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Duygu Geler Külcü

Prof Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nilgün Mesci, assoc prof

Role: STUDY_DIRECTOR

Haydarpaşa Numune education and research Hospital

Locations

Haydarpaşa Numune Education and Research Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Study Documents

Document Type: Study Protocol

View Document

Other Identifiers

FSMEAH-KAEK 2018/37

Identifier Type: -

Identifier Source: org_study_id