Continuous Positive Airway Pressure (CPAP) for Primary Care (CPAP-SU-MAP)

Validation of a Programme of Treatment and Follow-Up for Obstructive Sleep Apnea (OSA) Patients to be Applied by General Practitioners (GPs). Collaborative Network System Between GPs, CPAP Provider Enterprise and Sleep Specialists

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.

Study Overview

• Status: Completed
• Conditions: OSA
• Intervention / Treatment: Other: Follow up in Primary Care Group; Other: Follow up in Sleep Unit Group

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Araba
    • Vitoria, Araba, Spain, 01009
      • Hospital Universitario Araba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Other: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of hours of use per day of CPAP	Compare the objective CPAP compliance treatment in the two study groups.	Six month

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anthropometric variables (Body mass index)	Body mass index	Six month

Collaborators and Investigators

• Sponsor: Hospital Universitario Araba
• Collaborators: Linde Health Care; Spain:Health Department. Basque Government.
• Investigators: Principal Investigator: Joaquin Duran-Cantolla, MD, Hospital Universitario Araba

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: April 1, 2015
• First Submitted That Met QC Criteria: May 28, 2015
• First Posted (Estimate): June 2, 2015

Study Record Updates

• Last Update Posted (Actual): December 4, 2018
• Last Update Submitted That Met QC Criteria: December 3, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Primary care; Efficacy; OSA; CPAP treatment
• Other Study ID Numbers: 2010111082