Continuous Positive Airway Pressure (CPAP) for Primary Care

Not Applicable

Completed

• Conditions: OSA
• Interventions: Other: Follow up in Primary Care Group; Other: Follow up in Sleep Unit Group

• Registration Number: NCT02459548
• Lead Sponsor: Hospital Universitario Araba

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2015-04-01
• Study First Submitted QC: 2015-05-28
• Study First Posted: 2015-06-02
• Primary Completion: 2015-12
• Study Completion: 2016-05
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-03
• Last Update Posted: 2018-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Primary Care Group	Follow up in 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.
Sleep Unit Group	Follow up in 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.

Primary Outcome Measures

Name	Time	Method
Number of hours of use per day of CPAP	Six month	Compare the objective CPAP compliance treatment in the two study groups.

Secondary Outcome Measures

Name	Time	Method
Adverse events (number of CPAP complications)	Six month	Determine the number of CPAP complications (secondary effects).
Patient satisfaction (visual-analogical scale)	Six month	Evaluate the level of patient's satisfaction by visual-analogical scale.
Comorbidity index (Charlson index)	Six month	Charlson index
Level of clinical improvement evaluated through the Epworth Sleep Scale	At baseline and at 6 month of follow-up	Evaluate the level of clinical improvement from the start of treatment until 6 months by the changes in the Epworth Sleep Scale
Quality of life (EuroQOL test)	Baseline and at 6 month of follow up	Evaluate by EuroQOL test
Blood pressure	Six month	Blood pressure measurements
Cost-effectiveness analysis	Six month	Cost-efficacy evaluation

Trial Locations

Locations (1)

Hospital Universitario Araba; 🇪🇸 Vitoria, Araba, Spain