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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
220
Compare the results of a program of treatment and follow-up by Primary Care in patients with obstructive sleep apnea on CPAP treatment, versus the usual practice of control by the Sleep Unit.
Compare the results of a program of treatment and follow-up by Primary Care in patients with obstructive sleep apnea on CPAP treatment, versus the usual practice of control by the Sleep Unit.
Hospital Universitario Araba
Vitoria-Gasteiz, Araba, Spain
Number of hours of use per day of CPAP
Compare the objective CPAP compliance treatment in the two study groups.
Time frame: Six month
Level of clinical improvement evaluated through the Epworth Sleep Scale
Evaluate the level of clinical improvement from the start of treatment until 6 months by the changes in the Epworth Sleep Scale
Time frame: At baseline and at 6 month of follow-up
Patient satisfaction (visual-analogical scale)
Evaluate the level of patient's satisfaction by visual-analogical scale.
Time frame: Six month
Adverse events (number of CPAP complications)
Determine the number of CPAP complications (secondary effects).
Time frame: Six month
Quality of life (EuroQOL test)
Evaluate by EuroQOL test
Time frame: Baseline and at 6 month of follow up
Comorbidity index (Charlson index)
Charlson index
Time frame: Six month
Blood pressure
Blood pressure measurements
Time frame: Six month
Cost-effectiveness analysis
Cost-efficacy evaluation
Time frame: Six month
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