Viewing Study NCT06458777



Ignite Creation Date: 2024-06-16 @ 11:51 AM
Last Modification Date: 2024-10-26 @ 3:32 PM
Study NCT ID: NCT06458777
Status: COMPLETED
Last Update Posted: 2024-06-20
First Post: 2023-08-02

Brief Title: Evaluation of the Cost-Effectiveness and Sensitivity of Automatic Analysis Versus Manual Analysis of Polygraphy in the Diagnosis of Obstructive Sleep Apnea
Sponsor: Hospital San Pedro de Logroño
Organization: Hospital San Pedro de Logroño

Study Overview

Official Title: Evaluación de la Rentabilidad y Sensibilidad Del análisis automático Contra el análisis Manual de la poligrafía en el diagnóstico de Apnea Obstructiva Del sueño
Status: COMPLETED
Status Verified Date: 2024-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Obstructive sleep apnea OSA is a chronic pathology that affects more than 20 of the adult population It is one of the main sleep disorders with great clinical economic and social repercussions

To assess the impact and severity of obstructive sleep apnea the number of apneas and hypopneas per hour AHI is counted To define that a person has OAS a sleep study must have an AHI 15h predominantly obstructive or the presence of an AHI 5h accompanied by symptoms

The diagnosis of certainty or exclusion as well as the severity is established with a sleep study Polysomnography PSG continues to be the gold standard for the diagnosis of OSA it encompasses the recording of cardiorespiratory and neurophysiological variables which makes it possible to analyze sleep time and structure the presence of different respiratory episodes and their repercussions Respiratory polygraphy RP includes recording from a flow sensor respiratory effort oxygen saturation heart rate and also position but not EEG There are several studies that have explored the diagnostic agreement of RP versus PSG being a validated useful and necessary test for the diagnosis of OSA in different clinical situations Being cheaper and more accessible

When talking about the diagnosis of OSA it refers to establishing whether or not there is the severity and the therapeutic decision that will greatly affect the quality of life prognosis and day-to-day life of the patient since it is a chronic disease

It must be borne in mind that most studies are carried out in a field specialized in dream interpretation so caution must be exercised in interpreting results in another field PR teams incorporate increasingly better developed software that allows automatic analysis of records but the technology and algorithms used vary depending on the device and up to now the AASM continues to recommend manual analysis based on existing evidence Several studies have examined the agreement between automatic and manual analysis of the PR record or between automatic analysis of PR and PSG It seems that this agreement is reached above all in the highest AHIs above 25-30 which may limit its use in clinical practice

For this reason it is important to carry out a study with a large number of patients to achieve statistical significance and strong conclusions that support normal clinical practice and to disable a study that does not meet the scientific requirements when interpreting and reading
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None