Clinical trial NCT02459548: Continuous Positive Airway Pressure (CPAP) for Primary Care
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: OSA
Keywords: OSA
CPAP treatment
Primary care
Efficacy
Lead sponsor: Hospital Universitario Araba
Sponsor class: OTHER
Collaborators: name: Spain:Health Department. Basque Government.
name: Linde Health Care
First posted: 2015-06-02
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Number of hours of use per day of CPAP
timeFrame: Six month
Secondary outcomes:
measure: Level of clinical improvement evaluated through the Epworth Sleep Scale
timeFrame: At baseline and at 6 month of follow-up
measure: Patient satisfaction (visual-analogical scale)
timeFrame: Six month
measure: Adverse events (number of CPAP complications)
timeFrame: Six month
measure: Quality of life (EuroQOL test)
timeFrame: Baseline and at 6 month of follow up
measure: Comorbidity index (Charlson index)
timeFrame: Six month
measure: Blood pressure
timeFrame: Six month
measure: Cost-effectiveness analysis
timeFrame: Six month
Other outcomes:
measure: Anthropometric variables (Body mass index)
timeFrame: Six month
Locations:
city: Vitoria
country: Spain
facility: Hospital Universitario Araba
state: Araba
Study officials:
affiliation: Hospital Universitario Araba
name: Joaquin Duran-Cantolla, MD
role: PRINCIPAL_INVESTIGATOR
References: