Clinical trial NCT06136533: The Effect of Sarcopenic Obesity on Sleep in Individuals With Obesity Hypoventilation Syndrome
Official title: The Effect of Sarcopenic Obesity on Sleep in Individuals With Obesity Hypoventilation Syndrome
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Obesity Hypoventilation Syndrome (OHS)
Obesity
Hypoventilation
Respiration Disorders
Sleep Disorder; Breathing-Related
Sarcopenia
Sarcopenic Obesity
Keywords: Obesity Hypoventilation Syndrome (OHS)
Obesity
Sarcopenia
Sarcopenic Obesity
Sleep
Quality of Sleep
Sleep Disorder; Breathing-Related
Polysomnography
Lead sponsor: Istanbul University
Sponsor class: OTHER
Collaborators: name: Istanbul University - Cerrahpasa
First posted: 2023-11-18
Enrollment: 64
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals with Obesity Hypoventilation Syndrome followed up in Istanbul University Faculty of Medicine, Department of Chest Diseases are included in the study. The subjects are divided into two groups according to the presence of sarcopenia.

Brief summary: 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.

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

Primary outcomes:
measure: Polysomnography (PSG)-Apnea Hypopnea Index
timeFrame: 1 day
measure: Polysomnography (PSG)-Oxygen Desaturation Index
timeFrame: 1 day
measure: Polysomnography (PSG)-Minimum Oxygen Saturation
timeFrame: 1 day
measure: Polysomnography (PSG)-Oxygen Saturation
timeFrame: 1 day
measure: Pittsburgh Sleep Quality Index
timeFrame: 1 day
measure: Nottingham Health Profile
timeFrame: 1 day
measure: Functional Outcomes of Sleep Scale (FOSQ)
timeFrame: 1 day
measure: Epworth Sleepiness Scale
timeFrame: 1 day
Secondary outcomes:
measure: Modified Charlson Comorbidity Index
timeFrame: 1 day
measure: SARC-F Questionnaire
timeFrame: 1 day
measure: Body Mass Index
timeFrame: 1 day
measure: Body Fat Percentage
timeFrame: 1 day
measure: Body Fluid Percentage
timeFrame: 1 day
measure: Muscle Mass
timeFrame: 1 day
measure: Fat-free Muscle
timeFrame: 1 day
measure: Skeletal Muscle Mass
timeFrame: 1 day
measure: Skeletal Muscle Mass Index
timeFrame: 1 day
measure: Anthropometric Measurements-Neck
timeFrame: 1 day
measure: Anthropometric Measurements-Waist
timeFrame: 1 day
measure: Anthropometric Measurements-Abdomen
timeFrame: 1 day
measure: Anthropometric Measurements-Hip
timeFrame: 1 day
measure: The Waist-Hip ratio
timeFrame: 1 day
measure: Six Minutes Walk Test
timeFrame: 1 day
measure: The Short Physical Performance Battery (SPPB)
timeFrame: 1 day
measure: Respiratory Muscle Strength
timeFrame: 1 day
measure: Muscle Strength - Dynamometer
timeFrame: 1 day
measure: Physical Activity Level - Pedometer
timeFrame: 1 day
measure: Beck Depression Inventory
timeFrame: 1 day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Goksen KURAN ASLAN, Assoc. Prof.
role: STUDY_DIRECTOR
affiliation: Istanbul University - Cerrahpasa
name: Ece ACIKBAS, PT,MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University - Cerrahpasa
name: Ozge ERTAN HARPUTLU, PT,MSc
role: STUDY_CHAIR
affiliation: Marmara University
name: Melike SARITAS ARSLAN, PT,MSc
role: STUDY_CHAIR
affiliation: Istanbul University
name: Esen KIYAN, Prof.
role: STUDY_CHAIR
References: