Recruitment

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