Hospital San Pedro
Logroño, La Rioja, 26006, Spain
NCT Number: NCT06458777
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Logroño, La Rioja, 26006, Spain
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
OSA diagnosis
Time frame: 2 years
effectiveness of the analysis described with the AHI (number of sleep apneas in each hour slept)
Time frame: 2 years
economic cost (measured in euros) of manual and automatic polygraphy
Hospital San Pedro de Logroño
Other
Evaluación de la Rentabilidad y Sensibilidad Del análisis automático Contra el análisis Manual de la poligrafía en el diagnóstico de Apnea Obstructiva Del sueño.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05929079
Apnea, Body Weight
Anniston, Alabama, United States
View Trial DetailsNCT06146101
Apnea, Dyssomnias
Chula Vista, California, United States
View Trial DetailsNCT07723417
Apnea, Dyssomnias
Al Mansurah, Dakahlia Governorate, Egypt
View Trial DetailsNCT04950894
Apnea, Apnea+Hypopnea
Birmingham, Alabama, United States
View Trial Details