The Effect of Fibromyalgia Syndrome Accompanying Obstructive Sleep Apnea Syndrome on Clinical Findings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Fibromyalgia Impact Scale
研究概览
简要总结
Fibromyalgia Syndrome (FMS) is a chronic disease that lasts for at least three months and is characterized by various symptoms such as tender points, widespread pain in the musculoskeletal system, sleep disturbance and fatigue. Obstructive sleep apnea (OSAS) is a disease characterized by repeated upper airway obstruction during sleep. Sleep disorders negatively affect the lives of individuals. The prevalence of OSAS is between 1-5% in studies and it is more common in men than in women. Fatigue, anxiety, depression and sleep disturbance are also common in patients with fibromyalgia. Likewise, the presence of symptoms such as musculoskeletal pain in patients with OSAS suggests that these two diseases may be related to each other. We planned this study to show the relationship between OSAS and fibromyalgia (FM).
详细描述
Our research will be carried out on patients diagnosed with OSAS after being evaluated in the sleep laboratory of the Research Hospital Department of Chest Diseases. Fibromyalgia screening will be performed on participants who are diagnosed with OSAS and accepted to participate in the study. Patients with FM according to the 2010 American College of Rheumatology diagnostic criteria will be divided into two groups as FM patients (case group) and patients who do not meet these criteria (control group). Sleep laboratory results and demographic data of all patients will be recorded. In addition, anxiety, depression and fatigue levels will be evaluated with scales. Fibromyalgia impact questionnaire will be applied to fibromyalgia patients. Our study is a cross-sectional prospective case-control study. It is not a treatment research, an interventional application will not be made to the patients.
Our hypothesis is that OSAS patients with FMS may have more fatigue, anxiety, depression, lower algometer values, and more severe OSAS findings in polysomnographic data.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.18-60 years old
- •Diagnosed with OSAS in sleep laboratory examinations
- •Agree to participate in the study
排除标准
- •Neuropsychiatric disease
- •Inflammatory Rheumatic Diseases
- •Morbid obesity
- •Using a device with a previous diagnosis of OSAS
结局指标
主要结局
Fibromyalgia Impact Scale
时间窗: 0 day (baseline)
The fibromyalgia levels of the participants will be evaluated with the Fibromyalgia Impact Scale. High scores indicate increased disease activity. Consists of 10 questions Maximum score is 80. Turkish validity and reliability was done
Polisomnografi -SLEEP ACTIVITY
时间窗: 0 day (baseline)
Sleep efficiency will be measured during polysomnography
Polisomnografi - NUMBERS OF APNE
时间窗: 0 day (baseline)
Numbers of apnea will be recorded in polysomnographic measurements.
Polisomnografi -OXYGEN DESATURATION INDEX
时间窗: 0 day (baseline)
Minimum oxygen saturation and average oxygen saturation will be measured in polysomnography.
Demografic Datas
时间窗: 0 day (baseline)
Sex, chronic disease, smoking
Polisomnografi -REM time
时间窗: 0 day (baseline)
REM time will be measured in minutes during polysomnography
Fatigue Severity Scale
时间窗: 0 day (baseline)
"Fatigue Severity Scale" was used to evaluate the fatigue level of the participants. This scale consists of a 7-point Likert scale. 1 point means strongly disagree, 7 means strongly agree. High scores are associated with increased fatigue. Evaluates the effects of fatigue on physical function, motivation, family and social life. Turkish validity and reliability was established.
Beck Anxiety and Depression Inventory.
时间窗: 0 day (baseline)
Anxiety and depression levels will be evaluated with the Beck Anxiety and Depression Inventory. Turkish validity and reliability were done.Beck Depression Inventory (BDI) is a 21-item self-assessment scale that measures characteristic attitudes and symptoms of depression. The application takes about 10 minutes to complete. It is designed for people aged 13 and over. High scores report an increased level of depression.Beck anxiety scale This test, which consists of 21 optional questions, is accepted as an internationally valid tool used to measure the severity of anxiety in individuals.Each item marked on the Beck anxiety scale has a score. None is 0 points, mild 1 point, moderate 2 points, and severe 3 points. In this way, these scores are summed after 21 questions are marked. High scores indicate an increased level of anxiety.
Algometer.
时间窗: 0 day (baseline)
The pain threshold of all patients will be measured with an algometer. Measurement with an algometer is not an invasive measurement method. It shows the patient's pain sensitivity numerically according to the applied pressure.
BMI
时间窗: 0 day (baseline)
64 / 5.000 Çeviri sonuçları Body mass index will be calculated by measuring height (cm), weight (kg),
Polisomnografi -Apnea hypopnea index (AHI) REM, NONREM in polysomnography; Apnea hypopnea index (AHI) will be evaluated on a supine, non-supine basis.
时间窗: 0 day (baseline)
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+ )
Polisomnografi -NREM STAGES
时间窗: 0 day (baseline)
During polysomnography, NREM stages will be measured at 1 min, 2 min, and 3 min.
visual analog scale
时间窗: 0 day (baseline)
Pain levels will be evaluated with a visual analog scale. The VAS is a scale that evaluates the severity of pain with the Likert scale. Increased scores indicate severe pain.
Polisomnografi - SLEEP LATENCE
时间窗: 0 day (baseline)
Sleep latency time will be measured in polysomnography
Polisomnografi -NUMBER OF HYPOPNEA
时间窗: 0 day (baseline)
Numbers of hypopnea will be recorded in polysomnographic measurements.
次要结局
未报告次要终点
研究者
Basak Cigdem Karacay
Principal Investigator
Kirsehir Ahi Evran Universitesi