G47.3
Conditions
Interventions
Group 1: Observation group: Patients diagnosed with OSA and residual excessive daytime sleepiness despite current or prior OSA treatment. Ozawade® is prescribed independently of the study and in accor
24-weeks FU
- Baseline: demographics, cardiovascular and other diagnoses (Restless Legs Syndrome (RLS), Periodic Limb Movement in Sleep (PLMS), stroke, acute myocardial infarction (AMI)/acute coronary
Sponsors
Bioprojet Deutschland GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - OSA diagnosis according to the International Classification of Sleep Disorders 3rd Edition criteria - Residual excessive daytime sleepiness with ESS >=12 despite treatment, or after CPAP treatment attempt (or alternative OSA treatment attempt) - new treatment with Ozawade® (patient is treatment naïve to wake-promoting pharmacotherapy) - Signed informed consent by the patient Exclusion criteri
Exclusion criteria
Exclusion criteria: Patient is unable to understand the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of patients with reduction in daytime sleepiness assessed using the ESS scale of at least 3 points between baseline and 24 weeks. - 24 weeks ESS scale | — |
Secondary
| Measure | Time frame |
|---|---|
| - Trajectory of ESS change from baseline to 12 weeks and 24 weeks - ESS scale - Evaluation of basic cardiovascular parameters at 12 weeks and 24 weeks - heart rate and blood pressure - Change of disease related quality of life from baseline to the end of the study - FOSQ10 - Clinical improvement at end of study - PGI-C, FAS, CGI - Medication adherence at 12 and 24 weeks - Dropout rate - adverse drug reactions/AEs/SAEs | — |
Countries
Germany
Contacts
Public ContactMartin Schulz
CRO Dr. med. Kottmann GmbH & Co. KG
Outcome results
None listed