Registry on the Treatment of Central and Complex Sleep-Disordered Breathing With Adaptive Servo-Ventilation
Condition: Central Sleep Apnea; Complex Sleep Apnea; Obstructive Sleep Apnea; Mixed Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Apnea, Central
Study type: Observational [Patient Registry]

Summary: 
      Phase 1: The European ASV Registry (short name) will investigate the use of Adaptive
      Servo-Ventilation in non-heart failure conditions. The purpose is to examine the effects of
      ASV on quality of life, daytime symptoms and sleep, to describe usage patterns of ASV with
      regards to patient characteristics and to document adverse events related to therapy for a
      therapy safety analysis. A pilot phase will enrol at least 200 patients to test the
      feasibility of the registry. After the pilot phase will be completed and an intermediate data
      analysis had been performed, the registry will be expanded over several countries across
      Europe with the goal of enrolling up to 800 patients over a period of 5 years. Phase 2: The
      READ-ASV Registry (short name) will investigate the use of Adaptive Servo-Ventilation in
      non-heart failure conditions. The purpose is to examine the effects of ASV on quality of
      life, daytime symptoms and sleep, to describe usage patterns of ASV with regards to patient
      characteristics and to document adverse events related to therapy for a therapy safety
      analysis.
    

Detailed 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 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.
    

Intervention name(s): Adaptive Servo-Ventilation
Intervention type(s): Device
Intervention description(s): Adaptive Bi-Level positive airway pressure with a targeted minute ventilation and auto-adjusting expiratory pressure level.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The registry shall include adult individuals with a prescription of ASV therapy.
        Indications are sleep-related breathing disorders, including obstructive, central or
        complex sleep apnea.