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The goal of this observational study is to evaluate a new classification system for obstructive sleep apnoea in patients with newly diagnosed obstructive sleep apnoea and monitor for long-term objective and subjective improvement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| weak treatment indication | Patients with obstructive sleep apnoea (OSA) for whom OSA-specific treatment is generally not recommended according to the Baveno classification | ||
| intermediate treatment indication | Patients with obstructive sleep apnoea (OSA) for whom OSA-specific treatment should be considered based on individual assessment according to the Baveno classification | ||
| strong treatment indication | Patients with obstructive sleep apnoea (OSA) for whom OSA-specific treatment is generally recommended according to the Baveno classification |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in daytime sleepiness as measured by the Epworth Sleepiness Scale | The Epworth Sleepiness Scale total score ranges from 0-24. Higher values represent a larger extent of daytime sleepiness | From enrollment to the end of the individual observation period at 36 months |
| Change in office systolic blood pressure | From enrollment to the end of the individual observation period at 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in office diastolic blood pressure | From enrollment to the end of the individual observation period at 36 months | |
| Cardiovascular events (MACE) occurring after study inclusion, including but not limited to myocardial infarction, stroke, hospitalisation for cardiovascular-related treatment (e.g. heart failure, arrhythmia) |
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Inclusion criteria
Exclusion criteria
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Patients with suspected obstructive sleep apnoea presenting for sleep medical evaluation
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marcel Treml, Dr. | Contact | +49212636661 | marcel.treml@klinik-bethanien.de |
| Name | Affiliation | Role |
|---|---|---|
| Winfried J Randerath, Prof. Dr. | Wissenschaftliches Institut Bethanien für Pneumologie e.V. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Antwerp University Hospital | Not yet recruiting | Antwerp | Antwerp | B-2650 | Belgium |
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| From enrollment to the end of the individual observation period at 36 months |
| Average OSA treatment usage | Average usage of the prescribed treatment for obstructive sleep apnea, measured as hours per day, derived from therapy device data | From enrollment to the end of the individual observation period at 36 months |
| Number of patients who discontinue OSA treatment | From enrollment to the end of the individual observation period at 36 months |
| Change in Insomnia Severity Index total score | The Insomnia Severity Index (ISI) total score ranges from 0-28. Higher scores represent a larger extent of insomnia-related symptoms. Scores of 15 and above are indicative of clinical insomnia. | From enrollment to the end of the individual observation period at 36 months |
| Change in subjective sleep length | Subjective sleep length as assessed via personal interview, measured in hours per night | From enrollment to the end of the individual observation period at 36 months |
| Change in Fatigue Severity Scale mean score | The Fatigue Severity Scale (FSS) mean score ranges from 0-7, with higher values indicating a larger extent of fatigue. | From enrollment to the end of the individual observation period at 36 months |
| Change in cognitive performance as assessed by the Montreal Cognitive Assessment (MoCA) total score | The Montreal Cognitive Assessment (MoCA) total score ranges from 0-30. A higher score represents a better cognitive performance. A result of 26 or higher is considered normal. | From enrollment to the end of the individual observation period at 36 months |
| Change in average oxygen desaturation area as measured by overnight oximetry | The average oxygen desaturation area (unit: s*%) is automatically calculated from the oximetry signal of a single night poly(somno)graphy. Higher values indicate a larger extent of hypoxic burden. | From enrollment to the end of the individual observation period at 36 months |
| UZ Leuven | Recruiting | Leuven | Vlaams-Brabant | 3000 | Belgium |
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| Centre Hospitalier Universitaire Grenoble Alpes | Not yet recruiting | Grenoble | Isère | 38043 Cedex 9 | France |
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| Wissenschaftliches Institut Bethanien für Pneumologie e.V. | Recruiting | Solingen | 42699 | Germany |
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| Department of Pulmonology, University General Hospital of Alexandroupolis, Medical School, Democritus University of Thrace | Recruiting | Alexandroupoli | Evros | 68100 | Greece |
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| Division of Pulmonology, Department of Clinical Therapeutics, National and Kapodistrian University of Athens, Medical School | Not yet recruiting | Athens | Greece |
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| University of Crete | Recruiting | Heraklion | 71500 | Greece |
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| Respiratory Failure Unit, G. Papanikolaou Hospital | Not yet recruiting | Thessaloniki | Greece |
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| Istituto Auxologico Italiano | Not yet recruiting | Milan | 20149 | Italy |
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| Istituti Clinici Scientifici Maugeri IRCCS | Recruiting | Pavia | 27100 | Italy |
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| Institute of Tuberculosis and Lung Diseases | Recruiting | Warsaw | Masovian Voivodeship | 01-138 | Poland |
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| Unidade Local de Saúde de Gaia e Espinho ULSGE - Unidade de Patologia do Sons | Recruiting | Vila Nova de Gaia | Porto District | 4434-502 | Portugal |
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| Hospital Beatriz Ângelo, Unidade Local de Saúde Loures-Odivelas | Recruiting | Loures | 2674-514 | Portugal |
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| Clinica Somnolog | Recruiting | Bucharest | Romania |
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| University of Medicine and Pharmacy Dr. Victor Babes | Recruiting | Timișoara | Romania |
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| University Clinic of Respiratory and Allergic Diseases Golnik | Recruiting | Golnik | 4204 | Slovenia |
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| Klinik für Pneumologie Universitätsspital Zürich | Not yet recruiting | Zurich | Switzerland |
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| Ege University, Faculty of Medicine, Department of Respiratory Medicine | Recruiting | Izmir | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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