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The Effect of Sarcopenic Obesity on Sleep in Individuals With Obesity Hypoventilation Syndrome

— Observational Obesity Hypoventilation Syndrome (OHS) Obesity Hypoventilation Respiration Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Assessment-OHS, Assessment-Sarcopenic Obesity With OHS.
Who it may be relevant to
Registry conditions: Obesity Hypoventilation Syndrome (OHS), Obesity, Hypoventilation, Respiration Disorders. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Detailed description

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.

Interventions

  • Other Assessment-OHS
    Demographic information of individuals diagnosed with OHS without sarcopenia risk is recorded.Bioelectrical Impedance Analysis is used to analyze body composition.The comorbidity levels of the patients were assessed with the 'Modified Charlson Comorbidity Index',sleep quality was assessed with 'Polysomnography' and 'Pittsburgh Sleep Quality Index' and daytime sleepiness was assessed with the 'Epworth Sleepiness Scale'.The assessment of exercise capacity is performed with the 'Six Minute Walking
  • Other Assessment-Sarcopenic Obesity With OHS
    The sarcopenia diagnostic algorithm is used as a reference in the assessment of the presence of sarcopenic obesity. Demographic information of patients diagnosed with sarcopenic obesity is recorded. Then, the comorbidity levels of the patients were assessed with the 'Modified Charlson Comorbidity Index', sleep quality was assessed with 'Polysomnography' and 'Pittsburgh Sleep Quality Index', and daytime sleepiness was assessed with the 'Epworth Sleepiness Scale'. The assessment of exercise capaci

Primary outcome measures

  • Polysomnography (PSG)-Apnea Hypopnea Index [Time frame: 1 day]
  • Polysomnography (PSG)-Oxygen Desaturation Index [Time frame: 1 day]
  • Polysomnography (PSG)-Minimum Oxygen Saturation [Time frame: 1 day]
  • Polysomnography (PSG)-Oxygen Saturation [Time frame: 1 day]
  • Pittsburgh Sleep Quality Index [Time frame: 1 day]
  • Nottingham Health Profile [Time frame: 1 day]
  • Functional Outcomes of Sleep Scale (FOSQ) [Time frame: 1 day]
  • Epworth Sleepiness Scale [Time frame: 1 day]
Secondary outcome measures (12)
  • Modified Charlson Comorbidity Index [Time frame: 1 day]
  • SARC-F Questionnaire [Time frame: 1 day]
  • Body Mass Index [Time frame: 1 day]
  • Body Fat Percentage [Time frame: 1 day]
  • Body Fluid Percentage [Time frame: 1 day]
  • Muscle Mass [Time frame: 1 day]
  • Fat-free Muscle [Time frame: 1 day]
  • Skeletal Muscle Mass [Time frame: 1 day]
  • Skeletal Muscle Mass Index [Time frame: 1 day]
  • Anthropometric Measurements-Neck [Time frame: 1 day]
  • Anthropometric Measurements-Waist [Time frame: 1 day]
  • Anthropometric Measurements-Abdomen [Time frame: 1 day]

Eligibility criteria

Inclusion criteria

  • >50 years old
  • 30< BMI< 45 kg/m2
  • Patients who have undergone polysomnography evaluation within the last 6 months

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Turkey (Türkiye) · 1 center
  • Istanbul University-Cerrahpasa — Istanbul

Identifiers

NCT: NCT06136533 · 2023-2/GAslan

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗