Validity of a Home Respiratory Polygraphy for the Diagnosis of Obstructive Sleep Apnea

Study Overview
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Brief Summary
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To assess the diagnostic validity and cost-effectiveness of a APNiA device, a home respiratory polygraphy (HRP).

Detailed Description
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To assess the diagnostic validity and cost-effectiveness of a APNiA device, a home respiratory polygraphy (HRP), performed at home compared with the standard polysomnography (PSG) in adults with clinically suspected Obstructive Sleep Apnea (OSA). METHODOLOGY: DESIGN: Randomized, prospective, multicenter, and crossover trial. The study will include 240 adults, both sexes, with clinical suspicion of obstructive sleep apnea (OSA). MEASUREMENTS: To all patients with clinical suspected OSA and referred to the sleep units, the following questionnaires and measurements will be performed: a) clinical history; b) Anthropometric variables: weight, height, body mass index, neck circumference and percentile; c)Epworth sleepiness scale; OSA questionnaire, quality of life and clinical questionnaires and comorbidity; d) PSG in the sleep laboratory; e) HRP at home; f) Cost-effectiveness variables. ANALYSIS: Data from HRP and from full PSG will be compared as follows: 1) Agreement of results according to the different apnea-hypopnea index by using the Receiver Operating Characteristic (ROC) curve; 2) The concordance of the diagnosis and treatment decisions when using clinical findings and data from PSG or HRP at home; 3) All data will be analyzed independently; 4) A cost-effectiveness analysis of the different diagnostic and therapeutic procedures will be performed.

Official Title
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Validity and Cost-effectiveness Analysis of a Home Respiratory Polygraphy for the Diagnosis of Obstructive Sleep Apnea

Conditions
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Obstructive Sleep Apnea (OSA)

Intervention / Treatment
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* Other: Home Respiratory Polygraphy (APNIA)
* Other: Standard Polysomnography (PSG)
* Other: Home Respiratory Polygraphy (APNIA)
* Other: Standard Polysomnography (PSG)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women over 18 years to 75 years old, with clinical suspicion of OSA Written informed consent signed Exclusion Criteria: Psycho-Physical inability to perform the study at home Presence of insomnia or depressive syndrome Patient with malformation syndromes, Down syndrome and neuromuscular diseases Cardiovascular, cerebrovascular or respiratory disease exacerbated. Previous Positive continuous pressure (CPAP ) treatment or surgery for OSA

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diagnostic Randomizing<br>Randomizing to start with home respiratory polygraphy (APNIA) or Standard Polysomnography (PSG) | Other: Home Respiratory Polygraphy (APNIA)<br>* Randomizing to start with home respiratory polygraphy (APNIA)<br>* Other names: Validity;Other: Standard Polysomnography (PSG)<br>* Randomizing to start with Standard Polysomnography (PSG)<br>* Other names: Validity;|
| Active Comparator: Therapeutic Randomizing<br>Randomizing for therapeutic decision taken with home respiratory polygraphy (APNIA) or Standard Polysomnography (PSG) | Other: Home Respiratory Polygraphy (APNIA)<br>* Randomizing for therapeutic decision taken with home respiratory polygraphy (APNIA)<br>* Other names: Effectiveness;Other: Standard Polysomnography (PSG)<br>* Randomizing for therapeutic decision taken with Standard Polysomnography (PSG)<br>* Other names: Effectiveness;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea-Hypopnea Index (AHI) | To assess the diagnostic validity of a home respiratory polygraphy (HRP) compared with the standard polysomnography (PSG) in adults with clinically suspected Obstructive Sleep Apnea (OSA), based on the results of the Apnea-hypopnea Index (AHI). | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapeutic decision | The concordance of the diagnosis and treatment decision when using clinical findings and data from standard polysomnography (PSG) or home respiratory polygraphy (HRP). | 6 month | 
| Epworth Sleepiness Scale | The Epworth Sleepiness Scale (the sum of 8 items score,0-3) can range from 0 to 24. Scores of 11-24 represent increasing levels of excessive daytime sleepiness. | baseline and at 6 month | 
| STOP-BANG Sleep apnea questionnaire | Sleep Apnea Questionnaire. High STOP-Bang score indicates a high probability of obstructive sleep apnea. | baseline and at 6 month | 
| Berlin questionnaire | The questionnaire consists of 3 categories related to the risk of having sleep apnea. Patients can be classified into High Risk or Low Risk based on their responses to the individual items and their overall scores in the symptom categories. High Risk: if there are 2 or more categories where the score is positive. Low Risk: if there is only 1 or no categories where the score is positive. | baseline and at 6 month | 
| Cost-effectiveness analysis | Cost-efficacy evaluation | 6 month | 
| Blood pressure | Blood pressure measurements: systolic blood pressure and diastolic blood pressure | baseline and at 6 month | 
| Anthropometric variables (Body mass index) | Body mass index | baseline and at 6 month | 
| Quality of life (EuroQOL test) | Evaluate by EuroQOL test, is a standardised measure of health status. Description of the state of health in five dimensions (mobility, self-car, usual activities, pain/discomfort and anxiety/depression), each o wich is defined with three levels of severity, as measured by a Likert scale type (no problems, some problems and many problems or inability to activity). | baseline and at 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Home Respiratory Polygraphy, Standard Polysomnography, Validity, Cost-effectiveness