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

NCT06136533 | Not Yet Recruiting DMC

• 1 other identifier: 2023-2/GAslan
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (8)

• Polysomnography (PSG)-Apnea Hypopnea Index

  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.

  1 day

• Polysomnography (PSG)-Oxygen Desaturation Index

  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.

  1 day

• Polysomnography (PSG)-Minimum Oxygen Saturation

  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.

  1 day

• Polysomnography (PSG)-Oxygen Saturation

  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.

  1 day

• Pittsburgh Sleep Quality Index

  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.

  1 day

• Nottingham Health Profile

  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.

  1 day

• Functional Outcomes of Sleep Scale (FOSQ)

  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.

  1 day

• Epworth Sleepiness Scale

  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.

  1 day

Secondary Outcomes (20)

• Modified Charlson Comorbidity Index

  1 day

• SARC-F Questionnaire

  1 day

• Body Mass Index

  1 day

• Body Fat Percentage

  1 day

• Body Fluid Percentage

  1 day

Study Arms (2)

Obesity Hypoventilation Syndrome Group

Individuals diagnosed with OHS over the age of 18 years who met the inclusion criteria and who were followed up by Istanbul University Faculty of Medicine, Department of Chest Diseases

Other: Assessment-OHS

Obesity Hypoventilation Syndrome with Sarcopenic Obesity group

Individuals over the age of 18 years with a diagnosis of OHS and sarcopenic obesity who met the inclusion criteria and who were followed up by Istanbul University Faculty of Medicine, Department of Chest Diseases.

Other: Assessment-Sarcopenic Obesity With OHS

Interventions

Assessment-OHS OTHER

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 Test' and the assessment of respiratory muscle strength is performed with the 'Electronic Intraoral Pressure Measurement Device'.Patients' physical activity levels are monitored with a pedometer.Quadriceps muscle strength is measured with Hand-held dynamometer and grip strength is measured with Jamar hand dynamometer. The presence of depression is assessed with the 'Beck Depression Inventory' and quality of life with 'Nottingham Health Profile' and 'Functional Outcomes of Sleep Questionnaire'.

Also known as: Obesity Hypoventilation Syndrome Group

Obesity Hypoventilation Syndrome Group

Assessment-Sarcopenic Obesity With OHS OTHER

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 capacity is performed with the 'Six Minute Walking Test' and the assessment of respiratory muscle strength is performed with the 'Electronic Intraoral Pressure Measurement Device'. Patients' physical activity levels are monitored with a pedometer. Quadriceps muscle strength is measured with Hand-held dynamometer. The presence of depression is assessed with the 'Beck Depression Inventory' and quality of life with the 'Nottingham Health Profile' and the 'Functional Outcomes of Sleep Questionnaire'.

Also known as: Obesity Hypoventilation Syndrome with Sarcopenic Obesity group

Obesity Hypoventilation Syndrome with Sarcopenic Obesity group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead
• Istanbul University - Cerrahpasa: collaborator

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, 34320, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity Hypoventilation Syndrome; Obesity; Hypoventilation; Respiration Disorders; Sleep Wake Disorders; Sarcopenia; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Apnea; Respiratory Tract Diseases; Respiratory Insufficiency; Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Neurologic Manifestations; Mental Disorders; Muscular Atrophy; Neuromuscular Manifestations; Atrophy; Pathological Conditions, Anatomical

Study Officials

• Goksen KURAN ASLAN, Assoc. Prof.

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

• Ece ACIKBAS, PT,MSc

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

• Ozge ERTAN HARPUTLU, PT,MSc

  Istanbul University - Cerrahpasa

  STUDY CHAIR

• Melike SARITAS ARSLAN, PT,MSc

  Marmara University

  STUDY CHAIR

• Esen KIYAN, Prof.

  Istanbul University

  STUDY CHAIR

Central Study Contacts

Ece ACIKBAS, PT,MSc

CONTACT

+905545389767; ece.acikbas@gmail.com

Goksen KURAN ASLAN, Assoc. Prof.

CONTACT

+905324095246; goksenkuran@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Proffesor

Study Record Dates

• First Submitted: November 12, 2023
• First Posted: November 18, 2023
• Study Start: July 10, 2025
• Primary Completion: August 1, 2025
• Study Completion: October 1, 2025
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)