MedTrace Logo

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

NCT03415633 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 251

Last updated 2018-09-06

No results posted yet for this study

Summary

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

Conditions

  • Obstructive Sleep Apnea (OSA)

Interventions

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)

Sponsors & Collaborators

  • BTI Biotechnology Institute S.L

    collaborator UNKNOWN

  • Instituto de Investigación Sanitaria BIO-ARABA

    collaborator UNKNOWN

  • Hospital Universitario Araba

    lead OTHER

Principal Investigators

  • Joaquin Duran-Cantolla · Hospital Universitario Araba

  • Eduardo Anitua-Aldecoa · BTI Technology Institute SL

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2018-06-30
Completion
2018-09-30

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03415633 on ClinicalTrials.gov