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.
Study Type
OBSERVATIONAL
Enrollment
1,800
Antwerp University Hospital
Antwerp, Antwerp, Belgium
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
Time frame: From enrollment to the end of the individual observation period at 36 months
Change in office systolic blood pressure
Time frame: From enrollment to the end of the individual observation period at 36 months
Change in office diastolic blood pressure
Time frame: 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)
Time frame: 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
Time frame: From enrollment to the end of the individual observation period at 36 months
Number of patients who discontinue OSA treatment
Time frame: 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.
Time frame: From enrollment to the end of the individual observation period at 36 months
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UZ Leuven
Leuven, Vlaams-Brabant, Belgium
RECRUITINGCentre Hospitalier Universitaire Grenoble Alpes
Grenoble, Isère, France
NOT_YET_RECRUITINGWissenschaftliches Institut Bethanien für Pneumologie e.V.
Solingen, Germany
RECRUITINGDepartment of Pulmonology, University General Hospital of Alexandroupolis, Medical School, Democritus University of Thrace
Alexandroupoli, Evros, Greece
RECRUITINGDivision of Pulmonology, Department of Clinical Therapeutics, National and Kapodistrian University of Athens, Medical School
Athens, Greece
NOT_YET_RECRUITINGUniversity of Crete
Heraklion, Greece
RECRUITINGRespiratory Failure Unit, G. Papanikolaou Hospital
Thessaloniki, Greece
NOT_YET_RECRUITINGIstituto Auxologico Italiano
Milan, Italy
NOT_YET_RECRUITINGIstituti Clinici Scientifici Maugeri IRCCS
Pavia, Italy
RECRUITING...and 8 more locations
Change in subjective sleep length
Subjective sleep length as assessed via personal interview, measured in hours per night
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From enrollment to the end of the individual observation period at 36 months