OSA Clinical Trial
Official title:
Validation of a Programme of Treatment and Follow-Up for Obstructive Sleep Apnea (OSA) Patients to be Applied by General Practitioners (GPs). Collaborative Network System Between GPs, CPAP Provider Enterprise and Sleep Specialists
The objective of the study is to compare the results of a follow-up and treatment coordinate
and interactive program performed by the General Practitioners (GP) for Obstructive Sleep
Apnea (OSA) patients treated with positive continuous pressure (CPAP) vs. usual control by
sleep specialists from the sleep unit.
METHODOLOGY: DESIGN: Randomized comparative study. It will include patients with diagnosis of
severe OSA that should start treatment with CPAP. Participating center is Hospital
Universitario Araba in Vitoria-Gasteiz (Spain). These patients will be randomized to two
monitoring groups : 1 monitoring in the sleep unit; 2: monitoring in primary care
consultations by the General Practitioners (GP), once the OSA diagnosis has been made and it
was indicated the treatment with CPAP.
Patients will be carried out in both groups the same follow-up visits in two study arms:
basal, 1 month, 3 month and 6 months. PRIMARY OUTCOME: To compare the objective CPAP
compliance treatment in the two study groups, so that use >= 4h/day is defined as good
adherence to the treatment. SECONDARY OUTCOMES: 1)To evaluate the level of patient's
satisfaction by visual-analogical scales and quality of life tests; 2) to establish the
clinical improvement by somnolence and sleep scales; 3) To determine the numbers of CPAP
complications, type, severity and duration; 4) To figure-out the level of take care of the
CPAP machine, substitutions and complements, assistance and technical incidents; 5)
Cost-effectiveness analysis.
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