Continuous Positive Airway Pressure (CPAP) for Primary Care

NCT ID: NCT02459548

Last Updated: 2018-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2016-05-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Primary Care Group

This group will be follow up in Primary Care at 1, 3 and 6 month. At each visit patients receive advice on CPAP treatment, management of adverse effects associated with CPAP, making anthropometric and blood pressure measurements and also were asked to complete questionnaires.

Group Type: EXPERIMENTAL

Follow up in Primary Care Group

Intervention Type: OTHER

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.

Sleep Unit Group

This group will be follow up in Sleep unit at 1, 3 and 6 month. At each visit patients receive advice on CPAP treatment, management of adverse effects associated with CPAP, making anthropometric and blood pressure measurements and also were asked to complete questionnaires.

Group Type: OTHER

Follow up in Sleep Unit Group

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Men and women over 18 years old.
• Patients with OSA diagnosis performed in the sleep unit
• Written informed consent signed.

Exclusion Criteria

• Previous CPAP treatment for OSA diagnosis
• Psycho-physical inability to complete questionnaires
• Presence of any previously diagnosed sleep disorders: narcolepsy, insomnia, chronic sleep deprivations, regular use of hypnotic or sedative medications nad restless leg syndrome
• Patients with respiratory diseases (overlap syndrome, hypoventilation, restrictive diseases)
• A medical history that may interfere with the study objectives or, in the opinion of the investigator, compromise the conclusions.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spain:Health Department. Basque Government.

UNKNOWN

Sponsor Role: collaborator

Linde Health Care

OTHER

Sponsor Role: collaborator

Hospital Universitario Araba

OTHER

Sponsor Role: lead

Responsible Party

Joaquin Duran-Cantolla, MD

Joaquin Duran-Cantolla, MD Hospital Universitario Araba, Vitoria-Gasteiz (Spain)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joaquin Duran-Cantolla, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Araba

Locations

Hospital Universitario Araba

Vitoria-Gasteiz, Araba, Spain

Countries

Spain

Other Identifiers

2010111082

Identifier Type: -

Identifier Source: org_study_id