Status:
COMPLETED
Validity of a Home Respiratory Polygraphy for the Diagnosis of Obstructive Sleep Apnea
Lead Sponsor:
Hospital Universitario Araba
Collaborating Sponsors:
BTI Biotechnology Institute S.L
Instituto de Investigación Sanitaria BIO-ARABA
Conditions:
Obstructive Sleep Apnea (OSA)
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 clini...
Eligibility Criteria
Inclusion
- Men and women over 18 years to 75 years old, with clinical suspicion of OSA
- Written informed consent signed
Exclusion
- Psycho-Physical inability to perform the study at home
- Presence of insomnia or depressive syndrome
- Patient with malformation syndromes, Down syndrome and neuromuscular diseases
- Cardiovascular, cerebrovascular or respiratory disease exacerbated.
- Previous Positive continuous pressure (CPAP ) treatment or surgery for OSA
Key Trial Info
Start Date :
September 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2018
Estimated Enrollment :
251 Patients enrolled
Trial Details
Trial ID
NCT03415633
Start Date
September 1 2015
End Date
September 1 2018
Last Update
September 6 2018
Active Locations (1)
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1
Hospital Universitario Araba
Vitoria-Gasteiz, Araba, Spain, 01009