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

August 11, 2024 updated by: Goksen Kuran Aslan, Istanbul University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
      • Istanbul, Turkey, 34320
        • Istanbul University-Cerrahpaşa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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'.
Other Names:
  • Obesity Hypoventilation Syndrome Group
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
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'.
Other Names:
  • Obesity Hypoventilation Syndrome with Sarcopenic Obesity group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 day
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.
1 day
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.
1 day
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.
1 day
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.
1 day
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.
1 day
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.
1 day
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.
1 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Modified Charlson Comorbidity Index
Time Frame: 1 day
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).
1 day
SARC-F Questionnaire
Time Frame: 1 day
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.
1 day
Body Mass Index
Time Frame: 1 day
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.
1 day
Body Fat Percentage
Time Frame: 1 day
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.
1 day
Body Fluid Percentage
Time Frame: 1 day
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.
1 day
Muscle Mass
Time Frame: 1 day
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.
1 day
Fat-free Muscle
Time Frame: 1 day
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.
1 day
Skeletal Muscle Mass
Time Frame: 1 day
Values changes in total skeletal muscle mass (in kilograms) using bioelectrical impedance analysis and formulas.
1 day
Skeletal Muscle Mass Index
Time Frame: 1 day
Values changes in total skeletal muscle mass index using bioelectrical impedance analysis and formulas.
1 day
Anthropometric Measurements-Neck
Time Frame: 1 day
With the help of a tape measure, neck circumference is measured in cm.
1 day
Anthropometric Measurements-Waist
Time Frame: 1 day
With the help of a tape measure, waist circumference is measured in cm.
1 day
Anthropometric Measurements-Abdomen
Time Frame: 1 day
With the help of a tape measure, abdomen circumference is measured in cm.
1 day
Anthropometric Measurements-Hip
Time Frame: 1 day
With the help of a tape measure, hip circumference is measured in cm.
1 day
The Waist-Hip ratio
Time Frame: 1 day
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.
1 day
Six Minutes Walk Test
Time Frame: 1 day
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.
1 day
The Short Physical Performance Battery (SPPB)
Time Frame: 1 day
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).
1 day
Respiratory Muscle Strength
Time Frame: 1 day
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.
1 day
Muscle Strength - Dynamometer
Time Frame: 1 day
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.
1 day
Physical Activity Level - Pedometer
Time Frame: 1 day
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.
1 day
Beck Depression Inventory
Time Frame: 1 day
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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Istanbul University - Cerrahpasa (IUC)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Goksen KURAN ASLAN, Assoc. Prof., Istanbul University - Cerrahpasa (IUC)
  • Principal Investigator: Ece ACIKBAS, PT,MSc, Istanbul University - Cerrahpasa (IUC)
  • Study Chair: Ozge ERTAN HARPUTLU, PT,MSc, Istanbul University - Cerrahpasa (IUC)
  • Study Chair: Melike SARITAS ARSLAN, PT,MSc, Marmara University
  • Study Chair: Esen KIYAN, Prof., Istanbul University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 10, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 12, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-2/GAslan

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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