Home Nasal Pressure for Sleep Apnea Management in Primary Case

Study Overview
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Brief Summary
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Primary objectives: To determine the efficacy and cost-effectiveness of a management program for patients with obstructive sleep apnea syndrome (OSAS) carried out in primary or specialist healthcare. In the primary arm, the diagnosis and therapeutic decision will be made by means of a domiciliary nasal pressure (DNP) channel and oximetry while the specialist healthcare arm will use polysomnography (PSG) in a hospital. Patients with an intermediate-high suspicion of OSAS will be included, taking as primary variables the Epworth scale, for efficacy, and the Epworth scale and EuroQol 5D, for cost-effectiveness. Secondary objectives: efficacy of the two SAHS management programs according to the following secondary variables: a) quality-of-life tests: FOSQ questionnaire, SF36 and analogical wellbeing scale, b) adherence to and compliance with the treatment.

Detailed Description
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Design: prospective, randomized, controlled, open, parallel, non-inferiority. A total of 280 patients will be randomized for management on the basis of DNP (primary) or PSG (specialist), thereby giving rise to 4 groups: two treated and two not treated with CPAP. The former will undergo a home auto-titration. The follow-up will last 6 months and include 4 evaluations.

Official Title
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Efficacy and Cost-Effectiveness of a Super Simplified System for the Management of Patients With Sleep Apneas in Primary Healthcare.

Conditions
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Obstructive Sleep Apnea Syndrome

Intervention / Treatment
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* Device: Diagnosis, autoCPAP, follow up.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Snoring or apneas objectively observed during sleep by a partner; Symptoms that are potentially secondary to apneas/hypopneas with an intermediate-high probability of being treated with CPAP. In operative terms, Epworth scale ≥12 or previous cardiovascular disease; Age between 18 and 70 years; Absence of any clinical suspicion of any other sleep pathology susceptible to coinciding with daytime sleepiness. Exclusion Criteria: Psycho-physical incapacity to complete questionnaires; Documented structural or coronary heart disease uncontrolled by any medical treatment; Cheyne-Stokes syndrome; Patients subjected to uvulopalatopharyngoplasty; Significant nasal obstruction impeding the use of CPAP; Pregnancy; Lack of informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Primary.<br>Diagnosis, autoCPAP, follow up. | Device: Diagnosis, autoCPAP, follow up.<br>* comparison between the efficacy of two protocol<br>|
| Active Comparator: Hospital<br>Diagnosis, autoCPAP, follow up | Device: Diagnosis, autoCPAP, follow up.<br>* comparison between the efficacy of two protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of the extra- and intra-hospital programs using DNP or PSG, taking as primary variable the Epworth scale. |  | Before and after 6 months of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-effectiveness of the exta- and intra-hospital management programs using DNP or PSG, evaluated by means of the Epworth scale and EuroQol 5D. |  | Before and after 6 months of follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep apnea, portable monitor, primary care, cost-effectiveness, OSAS