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Continuous Positive Airway Pressure (CPAP) for Primary Care

NCT02459548 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2018-12-04

No results posted yet for this study

Summary

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.

Conditions

  • OSA

Interventions

OTHER

Follow up in Sleep Unit Group

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.

OTHER

Follow up in Primary Care Group

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.

Sponsors & Collaborators

  • Spain:Health Department. Basque Government.

    collaborator UNKNOWN

  • Linde Health Care

    collaborator OTHER

  • Hospital Universitario Araba

    lead OTHER

Principal Investigators

  • Joaquin Duran-Cantolla, MD · Hospital Universitario Araba

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2015-12-31
Completion
2016-05-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02459548 on ClinicalTrials.gov