Specific study targets and objectives

The overall objective is to generate a database useful for multiple scientific protocols

Base cohort

1. Primary objective:

  • to generate cross sectional data on anthropometrics, sleepiness measures and comorbidity in European patients with various degree of OSA severity.

2. Secondary objectives:

  • to measure the incidence of cardiovascular disease (hypertension, stroke, ischemic heart disease).
  • to prospectively explore the cardiovascular and overall mortality in OSA and its relation to OSA severity and cardiovascular risk factors.
  • to explore the effect of different OSA treatment modalities like CPAP, oral devices or surgery on hemodynamic and metabolic parameters (e.g. blood pressure, HbA1c, lipid status) as well as on cardiovascular morbidity, metabolic disorder and sleepiness.

3. Tertiary objectives:

  • to explore the dose-response relationship between OSA severity and hypertension, hyperglycemia, cardiovascular morbidity, metabolic disorder and sleepiness.
  • to assess the effect of age, gender, domicile as well as cardiovascular and metabolic comorbidity on cardiovascular endpoints in sleep apnea patients.
  • to assess the value of various sleep laboratory procedures in terms of diagnostic and treatment routines on outcome in sleep apnea patients.
  • to assess the safety, tolerability and compliance with long-term CPAP treatment, oral devices and surgery (safety and tolerability).

European sleep laboratory clinical process evaluation

  • to assess the regional differences across sleep laboratories in Europe regarding patient populations, treatment allocations, diagnostic work up, as well as adherence to therapy.
  • to transfer know-how and to unify procedures as well as to generate minimum standards between different European sleep laboratories by the use of a standardized data acquisition procedure.
  • to generate a data base to be used for future health economical assessments in sleep apnea patients in relation to the various national health care systems.

Substudy protocols to be generated from the joint database

  • to create a network of scientifically active sleep centres and a joint database to be used for specific patient recruitment in future collaborative studies (e.g. specific cardiovascular, metabolic, genetic and treatment protocols).