NCT01918449

Follow-up of Patients With Obstructive Sleep Apnea in Primary Care.

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: Sociedad Española de Neumología y Cirugía Torácica · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• OSA

Interventions

Type	Name	Description
OTHER	Clinical follow up by general practitioners in primary care	The study evaluates two different setting to follow up patients with obstructive sleep apnea on CPAP treatment

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-12-01
• Completion: 2014-06-01
• First posted: 2013-08-07
• Last updated: 2014-11-25

Locations

1 site across 1 country: Spain