Follow-up of Patients With Obstructive Sleep Apnea in 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 coordinated and interactive program for the treatment, monitoring and control of patients with a moderate-severe diagnosis of Obstructive Sleep Apnea (OSA) and treated with positive continuous pressure (CPAP), with the currently established situation. Methodology: Equivalence randomized comparative study . It will include patients with diagnosis of moderate-severe OSA (apnea-hypopnea Index >=15) that should start treatment with (CPAP). Participating center is Hospital Santa María-Arnau de Vilanova in Lleida (Spain).These patients will be randomized to two monitoring groups (1: monitoring in the Sleep disorders unit, 2: monitoring in primary care consultations) once the OSAS diagnosis has been made and it was indicated that treatment with CPAP. Patients Will be carried out in both groups the same follow-up visits in two study arms: basal, 1 month, 3 months and 6 months. Primary outcomes: number of hours of use per day (according to the accountant of the CPAP), so that use >= 4h/day is defined as good adherence to the treatment. Secondary outcomes: daytime sleepiness, patient satisfaction, Adverse events related to CPAP treatment. It will be collected demographic ,clinics and anthropometric variables. At the end of follow-up primary and secondary outcomes will be compared between two groups.

Official Title
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Follow-up of Patients With the Apnea-hypopnea Syndrome in Primary Care and Sleep Disorders Units. Equivalence Randomized Comparative Study on Compliance and Clinical Response.

Conditions
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OSA

Intervention / Treatment
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* Other: Clinical follow up by general practitioners in primary care


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 units 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 deprivation, regular use of hypnotic or sedative medications and 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. Any medical factor, social or geographical, that may jeopardize patient compliance.(e.g., alcohol consumption (more 80 gr/day in men and more than 60 gr / day in women), no fixed address, disorientation, or a history of non-compliance).

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Sleep Unit group<br>This group will have standard follow up in sleep unit at 1, 3 and 6 month. These patients will also be instructed in hygienic-dietary measures, standard care of cardiovascular risk factors and sleep hygiene counseling. | |
| Experimental: Primary Care group<br>This group will have standard follow up in primary care at 1, 3 and 6 month. These patients will also be instructed in hygienic-dietary measures, standard care of cardiovascular risk factors and sleep hygiene counseling. | Other: Clinical follow up by general practitioners in primary care<br>* The study evaluates two different setting to follow up patients with obstructive sleep apnea on CPAP treatment<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 | Number of hours of use per day of CPAP according to the internal clock of the CPAP device | Six month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daytime sleepiness | Epworth Sleepiness Scale (ESS) | At baseline and at 6 month of follow-up | 
| Patient satisfaction | visual analog scale (0-10) | Six month | 
| Adverse events | Adverse events related to CPAP treatment | Six month | 
| Quality of life | EuroQol | Baseline and at 6 month of follow up | 
| Cost-efficacy evaluation | Qualys | Six month | 
| Comorbidity index | Charlson index | Six month | 
| Blood pressure | Office blood pressure | Sixt month | 
| Lost of follow up | Percentage of patients lost during follow up | Six month | 

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