Clinical Trials Logo

Clinical Trial Summary

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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03415633
Study type Interventional
Source Hospital Universitario Araba
Contact
Status Completed
Phase N/A
Start date September 2015
Completion date September 2018

See also
  Status Clinical Trial Phase
Not yet recruiting NCT04939168 - Measuring Atomoxetine and Aroxybutynin In Patients With OSA Phase 2
Completed NCT02908529 - Atomoxetine and Oxybutynin in Obstructive Sleep Apnea Phase 1/Phase 2
Completed NCT03426631 - DAW1033B2 in Obstructive Sleep Apnea Phase 1/Phase 2
Completed NCT04206449 - Sleep Thermography for Diagnosis of Obstructive Sleep Apnea (TERMOAPNEA) N/A
Active, not recruiting NCT03018912 - Validating the Use of a Subjectively Reported Sleep Vital Sign N/A
Completed NCT02549508 - Comparison Study Using APAP With and Without SensAwake in Patients With OSA and PTSD N/A
Completed NCT01249924 - The Effectiveness of Perioperative CPAP to Reduce Obstructive Sleep Apnea Related Adverse Events N/A
Completed NCT00773721 - Foam Mask - Assessment of Bioburden in a New Mask Seal Material N/A
Completed NCT02314858 - Tailored Treatment to Enhance Risk Perception in Sleep Apnea N/A
Completed NCT01476917 - The ATLAST Long-Term Study Phase 2/Phase 3
Terminated NCT00730041 - Palatal Implants in Combination With Continuous Positive Airway Pressure to Treat Obstructive Sleep Apnea Phase 4
Completed NCT00850434 - Improved Automatic CPAP Algorithm to Treat Obstructive Sleep Apnea (OSA) N/A
Enrolling by invitation NCT04538755 - DAW2020 on OSA Endotypic Traits Phase 1/Phase 2
Completed NCT02501304 - Feasibility Study of the ReVENT Sleep Apnea System N/A
Withdrawn NCT02805777 - Vent Flow Study of Prototype Nasal CPAP Mask N/A
Completed NCT02097212 - Correlation Between Trachebroncho Malacia/Hyperdynamic Airway Collapse And Obstructive Sleep Apnea N/A
Active, not recruiting NCT02295306 - Overnight Polysomnography and Respiratory Volume Monitor
Completed NCT01939938 - Pilot Study of the Comparison of the Upper Airway Dynamics of Oronasal vs Nasal Masks With PAP Treatment N/A
Terminated NCT01877928 - Post-extubation Boussignac CPAP System in Adults With Moderate to Severe Obstructive Sleep Apnea N/A
Completed NCT00965783 - Predictors of the Metabolic Effect of Sleep Loss N/A