NCT03415633

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 251 (actual)
• Sponsor: Hospital Universitario Araba · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Obstructive Sleep Apnea (OSA)

Interventions

Type	Name	Description
OTHER	Home Respiratory Polygraphy (APNIA)	Randomizing to start with home respiratory polygraphy (APNIA)
OTHER	Standard Polysomnography (PSG)	Randomizing to start with Standard Polysomnography (PSG)
OTHER	Home Respiratory Polygraphy (APNIA)	Randomizing for therapeutic decision taken with home respiratory polygraphy (APNIA)
OTHER	Standard Polysomnography (PSG)	Randomizing for therapeutic decision taken with Standard Polysomnography (PSG)

Timeline

• Start date: 2015-09-01
• Primary completion: 2018-06-01
• Completion: 2018-09-01
• First posted: 2018-01-30
• Last updated: 2018-09-06

Locations

1 site across 1 country: Spain