Evaluation of the Cost-Effectiveness and Sensitivity of Automatic Analysis Versus Manual Analysis of Polygraphy in the Diagnosis of Obstructive Sleep Apnea.

Obstructive Sleep Apnea Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06458777
• Other study ID #: PI 608
• Status: Completed
• Start date: January 19, 2014
• Est. completion date: March 15, 2023

Study information

• Verified date: June 2024
• Source: Hospital San Pedro de Logroño
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 ≥15/h, predominantly obstructive, or the presence of an AHI ≥5/h 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3144
• Est. completion date: March 15, 2023
• Est. primary completion date: March 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Respiratory polygraphs carried out at the San Pedro Hospital in the period of time between 2014-2020.

• Polygraphs corresponding to patients over 18 years of age.

Exclusion Criteria:

• Poor technical quality of polygraphy

• Patients with >50% central apnea or presence of Cheyne-Stokes respiration (CSResp).

• Lack of automatic and/or manual analysis of the polygraph.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Diagnostic Test:
• poligraphy
OSA diagnosis

Locations

Country	Name	City	State
Spain	Hospital San Pedro	Logroño	La Rioja

Sponsors (1)

Lead Sponsor	Collaborator
Hospital San Pedro de Logroño

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the Cost-Effectiveness and Sensitivity of Automatic Analysis Versus Manual Analysis of Polygraphy in the Diagnosis of Obstructive Sleep Apnea.	effectiveness of the analysis described with the AHI (number of sleep apneas in each hour slept)	2 years
Primary	Evaluation of the Cost-Effectiveness and Sensitivity of Automatic Analysis Versus Manual Analysis of Polygraphy in the Diagnosis of Obstructive Sleep Apnea.	economic cost (measured in euros) of manual and automatic polygraphy	2 years