Registry on the Treatment of Central and Complex Sleep-Disordered Breathing With Adaptive Servo-Ventilation
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 200
Summary
- Conditions
- Central Sleep Apnea
- Complex Sleep Apnea
- Mixed Sleep Apnea
- Obstructive Sleep Apnea
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 99 years
- Gender
- Both males and females
Description
Phase 1: The collection of data will be performed during the course of clinical routine. In regular clinical practice, a first control visit (i.e. Follow-up number one) should occur during the first 6 months. Further follow-up visits are only indicated when the patient is reporting problems during t...
Phase 1: The collection of data will be performed during the course of clinical routine. In regular clinical practice, a first control visit (i.e. Follow-up number one) should occur during the first 6 months. Further follow-up visits are only indicated when the patient is reporting problems during the course of therapy. We recommend FU visit at least once year (after the first routine FU visit). Each patient will be included for 6 months, the total duration of phase 1 of the registry. Phase 2: The pilot phase 1 enrolled over 200 patients. After completion of the pilot phase the registry expands to 1 additional country in Europe with the goal of enrolling up to 800 patients over a period of 4 years. The collection of data will be performed during the course of clinical routine. In regular clinical practice, a first control visit (i.e. Follow-up number one) should occur after the first 12 months of therapy use. Further follow-up visits are only indicated when the patient is reporting problems during the course of therapy. Each patient will be included for a maximum of 15 months, whereas serious events will be tracked throughout the total duration of phase I and II of the registry.
Tracking Information
- NCT #
- NCT03032029
- Collaborators
- CRI-The Clinical Research Institute GmbH
- University Hospital Regensburg
- Investigators
- Not Provided