Obstructive Sleep Apnea (OSA) Clinical Trial
Official title:
Validity and Cost-effectiveness Analysis of a Home Respiratory Polygraphy for the Diagnosis of Obstructive Sleep Apnea
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.
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