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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorIstanbul University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

>50 years old

30< BMI< 45 kg/m2

Patients who have undergone polysomnography evaluation within the last 6 months

Disqualifiers

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 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Assessment-OHS

    Other intervention

    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 OHS

    Other intervention

    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'.

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: Obesity Hypoventilation Syndrome Group1 intervention
Group B: Obesity Hypoventilation Syndrome with Sarcopenic Obesity group1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 day
2

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.

Time frame
1 day
3

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.

Time frame
1 day
4

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.

Time frame
1 day

Secondary outcomes

1

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).

Time frame
1 day
2

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.

Time frame
1 day
3

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.

Time frame
1 day
4

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.

Time frame
1 day

Other outcomes

Sponsors and contacts

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Istanbul University

Lead sponsor

Istanbul University - Cerrahpasa

Collaborator

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