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

Evaluación de la Rentabilidad y Sensibilidad Del análisis automático Contra el análisis Manual de la poligrafía en el diagnóstico de Apnea Obstructiva Del sueño.

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Diagnostic test: poligraphy

• Study Type: Observational
• Enrollment (Actual): 3144

Contacts and Locations

Study Locations

• Spain
  • La Rioja
    • Logroño, La Rioja, Spain, 26006
      • Hospital San Pedro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Dream Unit Patients with diagnostic suspicion of OSA

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients diagnosed with manual report of polygraphy	Diagnostic test: poligraphy; OSA diagnosis
Patients diagnosed with automatical report of polygraphy	Diagnostic test: poligraphy; OSA diagnosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Hospital San Pedro de Logroño

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2014
• Primary Completion (Actual): March 28, 2020
• Study Completion (Actual): March 15, 2023

Study Registration Dates

• First Submitted: August 2, 2023
• First Submitted That Met QC Criteria: June 12, 2024
• First Posted (Actual): June 14, 2024

Study Record Updates

• Last Update Posted (Actual): June 20, 2024
• Last Update Submitted That Met QC Criteria: June 17, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: PI 608

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No