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临床试验/NCT06536894
NCT06536894已完成不适用

The Effect of the Presence Fibromyalgia Syndrome on Anthropometric and Ultrasonographic Measurements in Obstructive Sleep Apnea Syndrome

Kirsehir Ahi Evran Universitesi1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2024年8月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
77
试验地点
1
主要终点
Polisomnografi -SLEEP ACTIVITY

研究概览

简要总结

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.

详细描述

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.

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 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

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

结局指标

主要结局

Polisomnografi -SLEEP ACTIVITY

时间窗: Day 0 ( Baseline)

Sleep efficiency will be measured during polysomnography

Polisomnografi-REM

时间窗: Day 0 ( Baseline)

REM times will be evaluated in polysomnography

submental ultrasonography

时间窗: Day 0 ( Baseline)

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

Polisomnografi -NREM STAGES

时间窗: Day 0 ( Baseline)

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

Polisomnografi -NUMBER OF HYPOPNEA

时间窗: Day 0 ( Baseline)

Numbers of hypopnea will be recorded in polysomnographic measurements

Polisomnografi-NonREM

时间窗: Day 0 ( Baseline)

NonREM times will be evaluated in polysomnography

Polisomnografi- SLEEP LATENCE

时间窗: Day 0 ( Baseline)

Sleep latency time will be measured in polysomnography

Polisomnografi -REM time

时间窗: Day 0 ( Baseline)

REM time will be measured in minutes during polysomnography

Polisomnografi - NUMBERS OF APNE

时间窗: Day 0 ( Baseline)

Numbers of apnea will be recorded in polysomnographic measurements.

Polisomnografi -Apnea hypopnea index (AHI) in polysomnography; Apnea hypopnea index (AHI) will be evaluated on a supine, non-supine basis.

时间窗: Day 0 ( Baseline)

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+ )

Anthropometric Measurements

时间窗: Day 0 ( Baseline)

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.

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: Day 0 ( 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 -OXYGEN DESATURATION INDEX

时间窗: Day 0 ( Baseline)

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

次要结局

  • Pittsburgh Sleep Quality Index(Day 0 ( Baseline))
  • Fibromyalgia Impact Scale(Day 0 ( Baseline))

研究者

发起方
Kirsehir Ahi Evran Universitesi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Basak Cigdem Karacay

Assosc Prof

Kirsehir Ahi Evran Universitesi

研究点 (1)

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