The Effect of Sarcopenic Obesity on Sleep in Individuals With Obesity Hypoventilation Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Functional Outcomes of Sleep Scale (FOSQ)
研究概览
简要总结
Obesity Hypoventilation Syndrome(OHS) is characterized by daytime hypercapnia and sleep-disordered breathing without other causes of hypoventilation in individuals with a body mass index above 30 kg/m2. It is stated that obesity is at the basis of the metabolic changes seen in individuals diagnosed with OHS. Also sedentary lifestyle habits, which are common in obese individuals, cause the risk of sarcopenia due to loss of muscle strength and mass, accumulation of adipose tissue in the body, and decreased exercise capacity. Reduced exercise capacity due to obesity has been shown in the literature to strongly interact with mortality risk. As a result of obesity and all this negative picture, impaired emotional state and decreased quality of life are observed in individuals. Simultaneously, sleep parameters are also negatively affected. In particular, increased adipose tissue leads to loss of muscle mass and strength, increased risk of sarcopenia and sleep-related problems. The association of obesity and sarcopenia is referred to as 'sarcopenic obesity'. Sarcopenic obesity is defined as the coexistence of sarcopenia and obesity. The concept of sarcopenic obesity has recently taken its place in the literature. In particular, there are very few studies on its relationship with sleep parameters. However, while obesity is the basis of OHS, there are no studies on the presence and effects of sarcopenic obesity in this patient group. Based on this point, we aim to investigate the effects of sarcopenic obesity on sleep parameters, exercise capacity and quality of life in individuals with OHS.
详细描述
Individuals with Obesity Hypoventilation Syndrome followed up in Istanbul University Faculty of Medicine, Department of Chest Diseases will be included in the study. Cases will be divided into two groups according to the presence of sarcopenia. The study will be conducted in accordance with the Declaration of Helsinki and informed consent will be obtained from the patients participating in the study. Before starting the study, the purpose of the study will be explained to the participants and all information about the study will be provided. Patients who agree to participate in the study will be invited to Istanbul University Faculty of Medicine, Department of Chest Diseases on certain days. The sarcopenia diagnostic algorithm is used as a reference in the assessment of the presence of sarcopenic obesity. For the diagnosis of sarcopenic obesity, sarcopenia risk, muscle strength, muscle mass and physical performance level are assessed. Body composition, comorbid levels, sleep and sleep quality, daytime sleepiness, exercise capacity, respiratory muscle strength, peripheral muscle strength, physical activity level, emotional status, sleep-related quality of life and health-related quality of life are assessed in all individuals participating in the study.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>50 years old
- •30< BMI< 45 kg/m2
- •Patients who have undergone polysomnography evaluation within the last 6 months
排除标准
- •Patient who have immobilized for more than 15 days in the last 6 months
- •Patient who have used corticosteroids in the last 6 months
- •Patient who have been significant weight loss in the last 6 months
- •Patient who have been significant serious comorbidities (cognitive impairments, neuromuscular diseases, unstable heart problems, uncontrolled respiratory problems, unresolved thyroid problems, etc.) that may affect participation in the study
结局指标
主要结局
Functional Outcomes of Sleep Scale (FOSQ)
时间窗: 1 day
It is a test used to assess the physical, social and mental impact of excessive daytime sleepiness on activities of daily living. In the Turkish version of the FOSQ, the questions related to sexual activities were excluded and it consists of 26 questions. Each question is evaluated as no difficulty, mild, moderate, moderate, extreme and scored between 0-4 points. A low total score indicates functional insufficiency.
Epworth Sleepiness Scale
时间窗: 1 day
Epworth Sleepiness Scale was developed in 1991 by M.W. Developed by Johns. The scale developed to measure sleepiness qualitatively and quantitatively is practical and easy to evaluate and is widely used. Unlike similar scales, it is used to measure the general level of daytime sleepiness. A total score of 11 and above indicates excessive daytime sleepiness. Daytime sleepiness is assessed with this scale.
Polysomnography (PSG)-Oxygen Saturation
时间窗: 1 day
Polysomnography is the gold standard diagnostic method used in the diagnosis of sleep-related respiratory disorders. Polysomnography provides a detailed assessment of sleep. Polysomnography data performed in the last 6 months are recorded in order to evaluate the oxygen saturation as a percentage.
Polysomnography (PSG)-Oxygen Desaturation Index
时间窗: 1 day
Polysomnography is the gold standard diagnostic method used in the diagnosis of sleep-related respiratory disorders. Polysomnography provides a detailed assessment of sleep. The average number of desaturation episodes per hour is called the oxygen desaturation index (ODI). Desaturation episodes are generally described as a decrease in the mean oxygen saturation of ≥4% (over the last 120 seconds) that lasts for at least 10 seconds. Polysomnography data performed in the last 6 months are recorded to evaluate the oxygen desaturation index of the patients.
Pittsburgh Sleep Quality Index
时间窗: 1 day
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete. Developed by researchers at the University of Pittsburgh, the PSQI is intended to be a standardized sleep questionnaire for clinicians and researchers to use with ease and is used for multiple populations. The questionnaire has been used in many settings, including research and clinical activities, and has been used in the diagnosis of sleep disorders.
Polysomnography (PSG)-Minimum Oxygen Saturation
时间窗: 1 day
Polysomnography is the gold standard diagnostic method used in the diagnosis of sleep-related respiratory disorders. Polysomnography provides a detailed assessment of sleep. Polysomnography data performed in the last 6 months are recorded in order to evaluate the minimum oxygen saturation as a percentage.
Polysomnography (PSG)-Apnea Hypopnea Index
时间窗: 1 day
Polysomnography is the gold standard diagnostic method used in the diagnosis of sleep-related respiratory disorders. Polysomnography provides a detailed assessment of sleep. The apnea-hypopnea index (AHI) is the combined average number of apneas and hypopneas that occur per hour of sleep. According to the American Academy of Sleep Medicine (AASM) it is categorized into mild (5-15 events/hour), moderate (15-30 events/hr), and severe (\> 30 events/hr). Polysomnography data performed in the last 6 months are recorded to evaluate the apnea hypopnea index of the patients.
Nottingham Health Profile
时间窗: 1 day
The Nottingham Health Profile (NHP) is a general patient reported outcome measure which seeks to measure subjective health status. It is a questionnaire designed to measure a patient's view of their own health status, in a number of areas. The NHP consists of two parts. The first part focuses on health and comprises 38 items which deal with pain, energy, sleep, mobility, emotional reaction and social isolation. The second part focuses on life areas affected and consists of 7 items which deal with problems regarding occupation, housework, social life, family life, sexual function, hobbies and holidays. The second part of the NHP is optional and can be omitted without ruining the test results.
次要结局
- Anthropometric Measurements-Abdomen(1 day)
- SARC-F Questionnaire(1 day)
- Muscle Mass(1 day)
- Fat-free Muscle(1 day)
- Modified Charlson Comorbidity Index(1 day)
- Body Mass Index(1 day)
- Body Fluid Percentage(1 day)
- Skeletal Muscle Mass(1 day)
- The Waist-Hip ratio(1 day)
- Body Fat Percentage(1 day)
- Skeletal Muscle Mass Index(1 day)
- Anthropometric Measurements-Neck(1 day)
- Anthropometric Measurements-Waist(1 day)
- Anthropometric Measurements-Hip(1 day)
- Six Minutes Walk Test(1 day)
- Respiratory Muscle Strength(1 day)
- Muscle Strength - Dynamometer(1 day)
- Physical Activity Level - Pedometer(1 day)
- The Short Physical Performance Battery (SPPB)(1 day)
- Beck Depression Inventory(1 day)
研究者
Goksen Kuran Aslan
Associated Proffesor
Istanbul University