The objective of the study is to compare the results of a coordinated and interactive program for the treatment, monitoring and control of patients with a moderate-severe diagnosis of Obstructive Sleep Apnea (OSA) and treated with positive continuous pressure (CPAP), with the currently established situation. Methodology: Equivalence randomized comparative study . It will include patients with diagnosis of moderate-severe OSA (apnea-hypopnea Index \>=15) that should start treatment with (CPAP). Participating center is Hospital Santa María-Arnau de Vilanova in Lleida (Spain).These patients will be randomized to two monitoring groups (1: monitoring in the Sleep disorders unit, 2: monitoring in primary care consultations) once the OSAS diagnosis has been made and it was indicated that treatment with CPAP. Patients Will be carried out in both groups the same follow-up visits in two study arms: basal, 1 month, 3 months and 6 months. Primary outcomes: number of hours of use per day (according to the accountant of the CPAP), so that use \>= 4h/day is defined as good adherence to the treatment. Secondary outcomes: daytime sleepiness, patient satisfaction, Adverse events related to CPAP treatment. It will be collected demographic ,clinics and anthropometric variables. At the end of follow-up primary and secondary outcomes will be compared between two groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
210
The study evaluates two different setting to follow up patients with obstructive sleep apnea on CPAP treatment
Hospital santa Maria
Lleida, Catalonia, Spain
Number of hours of use per day of CPAP
Number of hours of use per day of CPAP according to the internal clock of the CPAP device
Time frame: Six month
Daytime sleepiness
Epworth Sleepiness Scale (ESS)
Time frame: At baseline and at 6 month of follow-up
Patient satisfaction
visual analog scale (0-10)
Time frame: Six month
Adverse events
Adverse events related to CPAP treatment
Time frame: Six month
Quality of life
EuroQol
Time frame: Baseline and at 6 month of follow up
Cost-efficacy evaluation
Qualys
Time frame: Six month
Comorbidity index
Charlson index
Time frame: Six month
Blood pressure
Office blood pressure
Time frame: Sixt month
Lost of follow up
Percentage of patients lost during follow up
Time frame: Six month
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