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It is not yet known whether an analysis of daytime sleepiness over the course of the day can predict the diagnosis or severity of sleep apnea. The goal of the study is to examine whether a psychometric determination of daytime sleepiness can adequately and practicably record daytime sleepiness in patients with mainly sleep apnea in comparison to other standardized methods.
Detailed Description: Sleep-related respiratory disorders are a common disease in the general population. Untreated sleep apnea is associated with an increased risk of accidents, an increased risk of perioperative complications and various cardiovascular diseases such as arterial hypertension, coronary heart disease or stroke. Sleep apnea is often undetected. As part of the diagnosis of sleep apnea, screening is usually carried out to assess the probability of pre-testing before a sleep medical examination by means of anamnesis, examination and recording of risk factors and comorbidities. Questionnaires play a decisive role here. The Epworth Sleepiness Scale (ESS) or the STOP BANG questionnaires are often used for this purpose. ESS asks about the probability of falling asleep in different situations. With STOP BANG, the points daytime tiredness, snoring, breathing stops and various risk factors such as age, sex, neck circumference, high blood pressure and overweight are asked. The quality of the questionnaire used to assess the risk of sleep apnea is of crucial importance, as it is usually the basis for the decision whether or not to perform further sleep medical diagnostics. To date, there is no established, easy-to-use method for measuring daytime sleepiness during the day. However, it can be assumed that the degree of daytime sleepiness can predict the presence of sleep apnea. In a proof-of-concept study, the psychometric determination of daytime sleepiness in a time series on one day in patients with mainly sleep apnea will be measured.
The following questions should be answered:
The quantification of daytime sleepiness can potentially be of crucial importance both for diagnostic procedures and for the assessment of the use of therapeutic measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with a clinical suspicion of sleep apnea (n=150) | patients with a clinical suspicion of sleep apnea |
| |
| healthy subjects (n=10) | healthy subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire for recording daytime sleepiness over the course of the day | Other | Questionnaire for recording daytime sleepiness over the course of the day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prediction of Sleep Apnea | the degree of daytime sleepiness can predict the presence of sleep apnea the degree of daytime sleepiness can predict the presence of sleep apnea | at Baseline |
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Inclusion criteria for patients
Exclusion criteria for patients:
Inclusion criteria for healthy subjects:
Exclusion criteria for healthy subjects:
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patients with the clinical suspicion of sleep apnea and healthy subject
The healthy subjects will be recruited at the Lung and Allergy Centre, Practice for Internal Medicine, Pneumology, Allergology, Sleep and Sports Medicine Neuss in the clinical routine. The patients are from the Lung and Allergy Centre, Practice for Internal Medicine, Pneumology, Allergology, Sleep and Sports Medicine in Neuss and from the Div. of Cardiology, Pulmonary Disease and Vascular Medicine from the University Hospital Düsseldorf.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefanie Keymel, MD | Contact | +492118118800 | ctsu@med.uni-duesseldorf.de | |
| Rabea Wagstaff, M.A. | Contact | +492118118914 | ctsu@med.uni-duesseldorf.de |
| Name | Affiliation | Role |
|---|---|---|
| Malte Kelm, Prof. Dr. | Heinrich-Heine University, Duesseldorf | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heinrich-Heine-University | Recruiting | Düsseldorf | North Rhine-Westphalia | 40225 | Germany |
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| Anamnesis and physicial examination | Other | Anamnesis and physical examination, e.g. medication, comorbidities, complaints |
|
| Questionnaire for quantifying daytime sleepiness | Other | the Epworth Sleepiness Scale (ESS) questionnaire and the STOP BANG Questionnaire |
|
| Pulmonary function test | Diagnostic Test | The measured values of spirometry/body plethysmography, CO diffusion and blood gas analysis are documented, if available. |
|
| Polygraphy | Diagnostic Test | Polygraphy is a non-invasive portable examination method that the patient uses in the home environment at night to measure possible sleep-related breathing disorders. Typically, the following measurement signals are recorded: nasal airflow, thoracic and abdominal breathing excursions, snoring and breathing sounds via a microphone, pulse, oxygen saturation and position. The evaluation results and the findings are checked by a physician. Essential parameters include the apnoea-hypopnoea index, the number of obstructive, central and mixed apnoea/hypopnoea, the number and duration of desaturation, snoring or the association with a certain position. |
|
| Lung and Allergy Centre | Recruiting | Neuss | North Rhine-Westphalia | 41462 | Germany |
|
| ID | Term |
|---|---|
| D006970 | Disorders of Excessive Somnolence |
| D012120 | Respiration Disorders |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D012140 | Respiratory Tract Diseases |
| D001049 | Apnea |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D007156 | Immunologic Memory |
| D012129 | Respiratory Function Tests |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D056704 | Adaptive Immunity |
| D007109 | Immunity |
| D055633 | Immune System Phenomena |
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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