Continuous Positive Airway Pressure (CPAP) for Primary Care

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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OSA

Intervention / Treatment
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* Other: Follow up in Sleep Unit Group
* Other: Follow up in Primary Care Group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Primary Care Group<br>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<br>* 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.<br>|
| Other: Sleep Unit Group<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OSA, CPAP treatment, Primary care, Efficacy