Cost-effectiveness of Home Respiratory Polygraphy

Study Overview
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Brief Summary
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Primary objectives: The efficacy of the therapeutic decision taken by respiratory polygraphy (RP) against polysomnography (PSG) using the Epworth scale; Secondary Objective: the cost-effectiveness of diagnosis and therapeutic decision valued using the Epworth Scale and EuroQol 5D. effectiveness of the therapeutic decision by means of: 1) quality of life tests, 2) adherence and compliance to treatment, 3) blood pressure MAP, 4) biochemistry determinations. Design: prospective, randomized, controlled, open, parallel of non-inferiority. 440 patients will be randomized to diagnose and follow treatment based on the RP or the PSG. The follow-up will last 6 months with 4 assessments. Statistical analysis: We will compare the change in the Epworth scale between both arms of treatment through analysis of covariance. The premise of non-inferiority is -2 at the lower limit of 95% IC. Secondary variables will be analyzed using differences in independent means (or non-parametric equivalent) or Chi2 for dichotomous variables. Cost-effectiveness: costs generated by one and another method will be evaluated against the effectiveness of the primary variable using Bayesian techniques

Detailed Description
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Design: Prospective, randomized, controlled, open, parallel noninferiority. 440 patients will be randomized to diagnose and follow treatment based on the PR or PSG generating four groups: two treated and two untreated with CPAP. The latter did not undergo self-certification home. The monitoring will be 6 months and 4 assessments. Statistical analysis: compare the change of the scale Epworth before and after the intervention between both treatment arms using analysis of covariance. The premise is non-inferiority of -1.6 at the lower limit of 95%. Secondary variables were analyzed by independent means differences (or nonparametric equivalent) or Chi2 for dichotomous variables. Cost-effectiveness: the costs generated by the two methods will be measured against the effectiveness of the primary endpoint using Bayesian techniques

Official Title
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Non-inferiority Randomized Control Trial About Efficacy and Cost-effectiveness of Home Respiratory Polygraphy Management in Sleep Apneas/Hypopneas Syndrome

Conditions
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Sleep Apnea Syndrome

Intervention / Treatment
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* Procedure: diagnosis and therapeutic decision
* Procedure: diagnosis and therapeutic decision


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Snoring or sleep apneas observed by partner Symptoms that may be secondary to the apneas/hypopneas - concretely, an ESS ≥10 Age between 18 and 70 Absence of clinical suspicion of any other sleep pathology which could cause daytime sleepiness Exclusion criteria: Psycho-physical inability to complete questionnaires documented structural or coronary cardiopathy not controlled by medical treatment Cheyennes-Stokes Syndrome Patient has undergone an uvulopalatopharyngoplasty Unable to provide 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 |
| --- | --- |
| Active Comparator: Hospital diagnosis<br>diagnosis of Sleep Apnea and therapeutic decision will perform according to polysomnography | Procedure: diagnosis and therapeutic decision<br>* A conventional polysomnography will be done to perform the diagnosis and therapeutic decision(CPAP or not). Treated and untreated will be followed 6 moths<br>|
| Experimental: Home diagnosis<br>diagnosis of Sleep Apnea and therapeutic decision will be perform according to home respiratory polygraphy | Procedure: diagnosis and therapeutic decision<br>* A home respiratory polygraphy will be done to perform the diagnosis and therapeutic decision(CPAP or not). Treated and untreated will be followed 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the efficacy of diagnosis and therapeutic decision-making evaluated using Epworth sleepiness scale as primary variable in patients managed by home RP and by PSG after six months of follow-up. |  | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the cost-effectiveness of diagnosis and therapeutic decision valued using the Epworth Scale and EuroQol 5D. |  | Six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep apnea, Portable monitor,autoCPAP