oticeably better sleep quality is objectively definable: How much steadier and deeper must sleepers breath?
- Conditions
- G47.31
- Registration Number
- DRKS00017471
- Lead Sponsor
- medscoops - Health Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 0
• 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
• 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
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Berlin Snoring Questionnaire, Insomnia Severity Index, Epworth Sleepiness Scale