To assess the diagnostic validity and cost-effectiveness of a APNiA device, a home respiratory polygraphy (HRP).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
251
Randomizing to start with home respiratory polygraphy (APNIA)
Randomizing to start with Standard Polysomnography (PSG)
Randomizing for therapeutic decision taken with home respiratory polygraphy (APNIA)
Hospital Universitario Araba
Vitoria-Gasteiz, Araba, Spain
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).
Time frame: baseline
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline and at 6 month
Cost-effectiveness analysis
Cost-efficacy evaluation
Time frame: 6 month
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Randomizing for therapeutic decision taken with Standard Polysomnography (PSG)
Blood pressure
Blood pressure measurements: systolic blood pressure and diastolic blood pressure
Time frame: baseline and at 6 month
Anthropometric variables (Body mass index)
Body mass index
Time frame: 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).
Time frame: baseline and at 6 month