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临床试验/NCT07743892
NCT07743892招募中不适用

The Relationship Between Body Awareness and Clinical Parameters in Patients With Obstructive Sleep Apnea

Karabuk University1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2026年5月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
47
试验地点
1
主要终点
Body awareness

研究概览

简要总结

Obstructive Sleep Apnea Syndrome (OSAS) is a chronic disease characterized by intermittent hypoxia and sleep fragmentation resulting from recurrent upper airway obstructions. The physiological and neurocognitive changes caused by the disease can affect how individuals perceive and interpret bodily sensations. Although body awareness plays a significant role in the perception and management of symptoms, its relationship with clinical parameters in individuals with OSAS has not been sufficiently investigated. Therefore, the aim of our study is to examine the relationship between body awareness and respiratory function, disease severity, fatigue, shortness of breath, and sleep quality in OSAS patients.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Receiving a diagnosis of OSA after polysomnography,
  • Having an Apnea-Hypopnea Index ≥5 for OSA,
  • Volunteering to participate in the study.

排除标准

  • Having severe orthopedic, neurological, or cardiac diseases,
  • Having a diagnosed lung disease,
  • Having a previous or current history of psychiatric or neurological disorders,
  • Not voluntarily participating in the study.

结局指标

主要结局

Body awareness

时间窗: Baseline

The Body Awareness Questionnaire (BAQ) will be used to assess individuals' body awareness. The scale score ranges from 18 to 26, with higher scores indicating higher awareness.

Dyspnea

时间窗: Baseline

Dyspnea is assessed with the modified Medical Research Council (mMRC) dyspnea scale. As the score increases, shortness of breath increases.

Disease severity

时间窗: Baseline

The evaluation will be based on the Apnea/Hypopnea index measured by polysomnography. An Apnea-Hypopnea Index \>5 indicates Obstructive Sleep Apnea Syndrome.

Fatigue severity

时间窗: Baseline

Fatigue will be assessed using the Fatigue Severity Scale. A score of 36 or higher indicates severe fatigue.

Sleep quality

时间窗: Baseline

Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PUKI). The total score ranges from 0 to 21, and a score above 5 indicates poor sleep quality.

Pulmonary function (Forced vital capacity (FVC)

时间窗: Baseline

Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. Forced vital capacity (FVC) will be measured.

Pulmonary function (Forced expiratory volume in the first second (FEV1)

时间窗: Baseline

Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. Forced expiratory volume in the first second (FEV1) will be measured.

Pulmonary function (FEV1 / FVC)

时间窗: Baseline

Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. FEV1 / FVC will be measured.

Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))

时间窗: Baseline

Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. Flow rate 25-75% of forced expiratory volume (FEF 25-75%) will be measured.

Pulmonary function (Peak flow rate (PEF))

时间窗: Baseline

Pulmonary function will be evaluated using the spirometry, according to American Thoracic Society and European Respiratory Society criteria. Peak flow rate (PEF) will be measured.

次要结局

未报告次要终点

研究者

发起方
Karabuk University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Musa Güneş

Principal Investigator, PhD

Karabuk University

研究点 (1)

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