OSA Clinical Trial
Official title:
Follow-up of Patients With the Apnea-hypopnea Syndrome in Primary Care and Sleep Disorders Units. Equivalence Randomized Comparative Study on Compliance and Clinical Response.
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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