Obesity Hypoventilation Syndrome (OHS)NCT06136533
The Effect of Sarcopenic Obesity on Sleep in Individuals With Obesity Hypoventilation Syndrome
An observational study of Obesity Hypoventilation Syndrome (OHS) and Obesity, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Obesity Hypoventilation Syndrome (OHS), Obesity, Hypoventilation
- What is being tested?
- Assessment-OHS and Assessment-Sarcopenic Obesity With OHS
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2025to 1 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- >50 years old
- 30< BMI< 45 kg/m2
- Patients who have undergone polysomnography evaluation within the last 6 months
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa
Istanbul, 34320
About this study
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.
Read the 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.
- Conditions
- Obesity Hypoventilation Syndrome (OHS), Obesity, Hypoventilation, Respiration Disorders, Sleep Disorder; Breathing-Related, Sarcopenia
- Being tested
- Assessment-OHS, Assessment-Sarcopenic Obesity With OHS
- Keywords
- Obesity Hypoventilation Syndrome (OHS), Obesity, Sarcopenia, Sarcopenic Obesity, Sleep, Quality of Sleep, Sleep Disorder; Breathing-Related, Polysomnography
- Medical subject headings
- Obesity Hypoventilation Syndrome, Obesity, Hypoventilation, Respiration Disorders, Sleep Wake Disorders, Sarcopenia, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment-OHSOther
Also called Obesity Hypoventilation Syndrome Group
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'.
Assessment-Sarcopenic Obesity With OHSOther
Also called Obesity Hypoventilation Syndrome with Sarcopenic Obesity group
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'.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Assessment-Sarcopenic Obesity With OHS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 day
Secondary outcomes (20)
Modified Charlson Comorbidity Index
The Charlson Comorbidity Index (CCI) was initially developed to predict the survival time of individuals diagnosed with cancer by assigning weights to specific diseases. Today, it is used as a guide for individuals with multiple comorbidities. In this index, diseases are scored based on their morbidity and mortality. The total score is calculated by summing the equivalent scores of diseases. Comorbidity classification is categorized as low (score ≤ 3), moderate (score 4 and 5), high (score 6 and 7), and very high comorbidity (score ≥ 8).
Measured: 1 day
SARC-F Questionnaire
SARC-F is a 5-question questionnaire that asks about strength, assisted walking, getting up from a chair, climbing stairs and falls. Each question is calculated on a "0-2" point scale. A score of zero represents the best score, while a score of ten represents the worst score. Individuals scoring between "0-3" points are considered healthy, while individuals scoring 4 points and above are considered symptomatic. Scores of 4 and above are reported to predict sarcopenia and sarcopenia-related adverse outcomes.
Measured: 1 day
Body Mass Index
Body mass index (BMI) is a value derived from the mass (weight) and height of a person. The BMI is defined as the body mass divided by the square of the body height, and is expressed in units of kg/m2, resulting from mass in kilograms and height in metres.
Measured: 1 day
Body Fat Percentage
The body fat percentage of a patient is the total mass of fat divided by total body mass, multiplied by 100; body fat includes essential body fat and storage body fat. The body fat percentage of the patients will be evaluated by using the "Tanita BC-545N Body Analysis Scale" with the bioelectrical impedance analysis technique. And results are recorded in percent.
Measured: 1 day
Body Fluid Percentage
Body fluids, bodily fluids, or biofluids are liquids within the human body. The body fluid percentage of the patients will be evaluated by using the "Tanita BC-545N Body Analysis Scale" with the bioelectrical impedance analysis technique. And results are recorded in percent.
Measured: 1 day
Muscle Mass
Muscle mass refers to the amount of soft muscle tissue in the body. The muscle mass of the patients will be evaluated by using the "Tanita BC-545N Body Analysis Scale" with the bioelectrical impedance analysis technique. And results are recorded in kg.
Measured: 1 day
Fat-free Muscle
Fat-free mass, sometimes conflated with lean body mass, includes your body's water, organs, bone, and muscle content. In other words, it refers to all of your body components except fat. Fat-free mass is evaluated trough Bioelectrical Impedance Analysis.
Measured: 1 day
Skeletal Muscle Mass
Values changes in total skeletal muscle mass (in kilograms) using bioelectrical impedance analysis and formulas.
Measured: 1 day
Skeletal Muscle Mass Index
Values changes in total skeletal muscle mass index using bioelectrical impedance analysis and formulas.
Measured: 1 day
Anthropometric Measurements-Neck
With the help of a tape measure, neck circumference is measured in cm.
Measured: 1 day
Anthropometric Measurements-Waist
With the help of a tape measure, waist circumference is measured in cm.
Measured: 1 day
Anthropometric Measurements-Abdomen
With the help of a tape measure, abdomen circumference is measured in cm.
Measured: 1 day
Anthropometric Measurements-Hip
With the help of a tape measure, hip circumference is measured in cm.
Measured: 1 day
The Waist-Hip ratio
With the help of a tape measure, waist and hip circumference is measured in cm. Depending on the circumference measurements, waist and hip circumference is calculated as waist to hip ratio.
Measured: 1 day
Six Minutes Walk Test
The distance covered in meters in a straight corridor of 30 meters will be recorded as fast as possible but without running for 6 minutes. The distance that normal individuals should take in this period is 400-700 meters. In addition, oxygen saturation and heart rate, resting fatigue and dyspnea levels will be evaluated with pulse oximetry before and after testing. Modified Borg Dyspnea and Fatigue Scales will be used to determine resting dyspnea and fatigue levels.
Measured: 1 day
The Short Physical Performance Battery (SPPB)
SPPB scale will be used to measure physical function, which is a well-established tool for monitoring function in older people, which contains three kinds of assessments: stand for 10 seconds with feet in 3 different positions, 3-meter or 4-meter walking speed test, and time to rise from a chair for five times. The scores of SPPB range from 0 (worst performance) to 12 (best performance).
Measured: 1 day
Respiratory Muscle Strength
Measurement of respiratory muscle strength will be performed using an electronic mouth pressure measurement device, the "MicroRPM" brand (Micro Medical; UK), in accordance with American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Measured: 1 day
Muscle Strength - Dynamometer
Measurement of respiratory muscle strength will be performed using an electronic mouth pressure measurement device, the "MicroRPM" brand (Micro Medical; UK), in accordance with ATS and ERS criteria.
Measured: 1 day
Physical Activity Level - Pedometer
A pedometer is a small portable device that measures and displays physical activity and counts steps. All patients included in the study use it for 1 week. Each patient will be given 1 pedometer and patients will be asked to record their 1-week data daily on the follow-up chart. It is planned to be used to monitor the daily physical activity level of the patients.
Measured: 1 day
Beck Depression Inventory
Beck Depression Inventory (BDI-II) Scale is a 21-item self-reported questionnaire which measures the existence and severity of symptoms of depression. Each of the 21 items on BDI-II tool represents a depressive symptom. The symptoms are each scored on a 4-point Likert scale of 0 to 3 (0=symptom is absent; 3=symptom is severe). Scores for each symptom are added up to obtain the total scores for all 21 items. Total score ranges from 0-63; of which 0-8 is considered no depression, 0-13 is minimal depression, 14-19 is mild depression, 20-28 is moderate depression and 29-63 is severe depression.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start10 Jul 2025 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity Hypoventilation Syndrome (OHS)Studies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Principal investigator, Goksen Kuran Aslan, Istanbul University
- Investigators
- Goksen KURAN ASLAN, Assoc. Prof., Study director, Istanbul University - CerrahpasaEce ACIKBAS, PT,MSc, Principal investigator, Istanbul University - CerrahpasaOzge ERTAN HARPUTLU, PT,MSc, Study chair, Istanbul University - CerrahpasaMelike SARITAS ARSLAN, PT,MSc, Study chair, Marmara UniversityEsen KIYAN, Prof., Study chair, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06136533
- Sponsor's protocol ID
- 2023-2/GAslan
- Status last verified
- Aug 2024
- First submitted
- 12 Nov 2023
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sarcopenic Obesity on Sleep in Individuals With Obesity Hypoventilation Syndrome
- ClinicalTrials.gov ID
- NCT06136533
- Acronym / sponsor ID
- 2023-2/GAslan
- Conditions
- Obesity Hypoventilation Syndrome (OHS), Obesity, Hypoventilation, Respiration Disorders, Sleep Disorder; Breathing-Related, Sarcopenia
- Keywords
- Obesity Hypoventilation Syndrome (OHS), Obesity, Sarcopenia, Sarcopenic Obesity, Sleep, Quality of Sleep, Sleep Disorder; Breathing-Related, Polysomnography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 10 Jul 2025 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obesity Hypoventilation Syndrome Group | – | Other: Assessment-OHSIndividuals 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 |
| Obesity Hypoventilation Syndrome with Sarcopenic Obesity group | – | Other: Assessment-Sarcopenic Obesity With OHSIndividuals 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- >50 years old
- 30< BMI< 45 kg/m2
- Patients who have undergone polysomnography evaluation within the last 6 months
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment-OHSAlso: Obesity Hypoventilation Syndrome GroupDemographic 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'. | Other | Obesity Hypoventilation Syndrome Group |
| Assessment-Sarcopenic Obesity With OHSAlso: Obesity Hypoventilation Syndrome with Sarcopenic Obesity groupThe 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'. | Other | Obesity Hypoventilation Syndrome with Sarcopenic Obesity group |
Primary outcome
Polysomnography (PSG)-Apnea Hypopnea Index
Time frame: 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.
Polysomnography (PSG)-Oxygen Desaturation Index
Time frame: 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.
Polysomnography (PSG)-Minimum Oxygen Saturation
Time frame: 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)-Oxygen Saturation
Time frame: 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.
Pittsburgh Sleep Quality Index
Time frame: 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.
Nottingham Health Profile
Time frame: 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.
Functional Outcomes of Sleep Scale (FOSQ)
Time frame: 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
Time frame: 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.
20 secondary outcomes
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
Anthropometric Measurements-Hip
Time frame: 1 day
The Waist-Hip ratio
Time frame: 1 day
Six Minutes Walk Test
Time frame: 1 day
The Short Physical Performance Battery (SPPB)
Time frame: 1 day
Respiratory Muscle Strength
Time frame: 1 day
Muscle Strength - Dynamometer
Time frame: 1 day
Physical Activity Level - Pedometer
Time frame: 1 day
Beck Depression Inventory
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Individual participant dataSharing planned: No
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Obstructive Sleep Apnea, Obesity (BMI>30)
RecruitingObservational study
The Use of Entropy to Assess Sleep Disordered Breathing in Chronic Respiratory Disease
Bronchial Asthma, Bronchiectasis
Not yet recruiting
The Effect of Mask Design on Ventilation Parameters in COPD and OHS Patients on Long-term Home Non-invasive Ventilation. An Experimental Study.
COPD (Chronic Obstructive Pulmonary Disease), Obesity Hypoventilation Syndrome (OHS)
Recruiting
Assessment of Breathing Pattern During NIV
COPD (Chronic Obstructive Pulmonary Disease), Obesity Hypoventilation Syndrome (OHS)
Not yet recruitingObservational study
Evaluation of Upper Extremity Functions in Obesity Hypoventilation Syndrome Patients
Obesity Hypoventilation Syndrome (OHS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Goksen KURAN ASLAN, Assoc. Prof. study director
Istanbul University - Cerrahpasa
Ece ACIKBAS, PT,MSc principal investigator
Istanbul University - Cerrahpasa
Ozge ERTAN HARPUTLU, PT,MSc study chair
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity Hypoventilation Syndrome (OHS) and Obesity, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ece ACIKBAS, PT,MSc (+905545389767, ece.acikbas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Polysomnography (PSG)-Apnea Hypopnea Index (time frame: 1 day). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.