G47.31
Conditions
Interventions
Group 1: General information
• observational study
i.e. only one study arm
• time points: T0 (day 1), T1 (day 2), T2 (day 50 or 90) und T3 (day 360)
• primary outcome: subjective rating at T1, T2 and T3 of the impairment by the obstructive sleep apnoe
medical records for all other required data (as part of the clinical routine)
• data protection: the case report forms are pseudonymous and always remain at the study centre of the department of otorh
in the electronic data set the data are pseudonymous during the validation and afterwards anonymous
• data quality: weekly validations per routine of the statistics program
as needed followed by inquiries to the participants
Additional effort for the participants
The interrogations at T1, T2 and T3 last about 10 minutes each.
Analysis
A cut point is determined that cla
Sponsors
medscoops - Health Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Body mass index below 35 kg/m² • Obstructive sleep apnoea .. • diagnosed for the first time at T1 at the Sleep Medicine Centre of the Otorhinolaryngology Department of the Mainz University Medical Centre .. • still untreated at T1 • Consent into an auto-titrating ventilation as part of the routine therapy • Written informed consent into study participation including .. • three interviews of 10 minutes each (see “Primary Outcome”) .. • pseudonymised data electronic storage and validation of personal data
Exclusion criteria
Exclusion criteria: • Actual known pregnancy, known cardiac insufficiency, chronic obstructive pulmonary disease stadium III or higher according to GOLD, psychiatric, neurologic or neurodegenerative diseases, narcolepsy or restless-legs syndrome • Status after apoplexy, myocardial infarction or malign neoplasm • Further disease that influence the apnoea-hypopnoea-index (predictor) and the sleepiness during the day • Neuroleptics, antiepileptic drugs, antidepressants, sedatives and further substances that influence the apnoea-hypopnoea-index (predictor) and the sleepiness during the day
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective appraisal at T1, T2, and T3 of the impairment caused by the obstructive sleep apnea; the four categories are "irrelevant", "mild", "middle", and "severe". | — |
Secondary
| Measure | Time frame |
|---|---|
| Berlin Snoring Questionnaire, Insomnia Severity Index, Epworth Sleepiness Scale | — |
Countries
Germany
Contacts
Public ContactRafael Cámara
medscoops - Health Sciences
Outcome results
None listed