The Incidence of Fibromyalgia in Patients with OUAS and the Effect of CPAP Treatment on Fibromiyalgia Symptom Severity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Visual Analoge Scale
研究概览
简要总结
-------------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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being between the ages of 1-30-65
- •Being diagnosed with Obstructive Sleep apnea syndrome and/or having CPAP treatment indication
排除标准
- •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
结局指标
主要结局
Visual Analoge Scale
时间窗: From enrollment to the end of treatment at 12 weeks
Mnimum-maximum values: 0-10 Higher scores mean worse outcome for pain scores
Algometer
时间窗: From enrollment to the end of treatment at 12 weeks
pain pressure treshold measurements unit: kg/m2 Higher scores mean better outcome
Fibromiyalgia Fatigue Scale Questionnaire
时间窗: From enrollment to the end of treatment at 12 weeks
min-max scores:0-72 measures disability Higher scores mean worse outcome
Fibromiyalgia Impact Questionnaire
时间窗: From enrollment to the end of treatment at 12 weeks"
measures disability level of patients with Fibromyalgia min-max scores: 0-100 Higher scores mean worse outcome
次要结局
- Epworth Sleepness Scale Questionnaire(From enrollment to the end of treatment at 12 weeks)
- Back Depression Inventory(From enrollment to the end of treatment at 12 weeks)
研究者
Duygu Geler Külcü
Prof Dr
Haydarpasa Numune Training and Research Hospital