An interventional study of Therapeutic decision PSG and Therapeutic decision Infrared thermgraphy system in Obstructive Sleep Apnea (OSA), sponsored by Hospital Universitario Araba. Completed at 1 site in Spain. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-04-03.
Sponsored by Hospital Universitario Araba · Not applicable, Interventional, and Diagnostic
To assess the diagnostic validity and cost-effectiveness of an infrared thermography system in adults with clinical suspicion of Obstructive Sleep Apnea (OSA).
AIMS: To assess the diagnostic validity and cost-effectiveness of an infrared thermography system, integrated in an expert diagnostic algorithm (TIS), to determine the sleep stages and identify respiratory events, compared to conventional polysomnography (PSG) in adults with clinical suspicion of Obstructive Sleep Apnea (OSA).
METODOLOGY: DESIGN: Prospective, unicentric, randomized and blinded study carried out into two phases: Phase I: Development of the tool in 99 full valuable adults with suspected OSA (PSG recruitment, coordination and quality control, image capture, Information and development of the expert system); Phase II: Validation of the tool compared with the PSG in another group of 99 full valuable adults with suspected OSA. INSTRUMENTALIZATION: a) Clinical history and anthropometric variables; b) Sleep and quality of life questionnaires; c) PSG; d) TIS; e) Cost-effectiveness study.
ANALYSYS : The validity of the results of the TIS will be analyzed compared with the results of the PSG. The agreement measure will be established according to the different categories of the Apnea-Hypopnea Index (AHI), using ROC (Receiver Operating Characteristic) curves and the area under the curve. The investigators will also validate the therapeutic decisions made with PSG compared to those performed with the TIS. Finally, a cost-effectiveness study will be performed.
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
This study's enrollment of 198 is above the median of 52 across 1,472 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Hospital Universitario Araba is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Therapeutic decision taken with infrared thermography system, integrated in an expert diagnostic algorithm (TIS), to determine the sleep stages and Apnea-Hypopnea Index (AHI).
Other: Therapeutic decision Infrared thermgraphy system
Therapeutic decision taken with Standard Polysomnography (PSG), to determine the sleep stages and Apnea-Hypopnea Index (AHI)
Other: Therapeutic decision PSG
Randomizing for therapeutic decision taken with Standard Polysomnography (PSG)
Also randomizing for Infrared thermography system
Apnea-Hypopnea Index (AHI)
Count the respiratory events (apneas and hypopneas) that occur during sleep using a high sensitivity infrared thermal camera integrated in an expert diagnostic algorithm (TIS).
Time frame: Baseline
Validation of the therapeutic decision
Analyze the concordance in the therapeutic decision using clinical findings and the results of Apnea-Hypopnea Index (AHI) from standard polysomnography (PSG) compared with data from infrared thermography system. In the Phase II.
Time frame: 6 month
Cost effectiveness analysis
Cost-efficacy evaluation: the analysis will be made in both arms based on intention to treat. Only direct costs will be analyzed: the cost of the use of polysomnography and infrared thermography system (Staff and consumable material).
Time frame: 6 month
Epworth Sleepiness Scale
The Epworth Sleepiness Scale (the sum of 8 items score,0-3) can range from 0 to 24. Scores of 11-24 represent increasing levels of excessive daytime sleepiness.
Time frame: baseline and at 6 month
STOP-Bang Questionnaire
The questionnaire screens for obstructive sleep apnea (OSA): * Low risk of OSA: \<3 * High risk of OSA: ≥3
Time frame: baseline and at 6 month
Berlin questionnaire
The questionnaire consists of 3 categories related to the risk of having sleep apnea. Patients can be classified into High Risk or Low Risk based on their responses to the individual items and their overall scores in the symptom categories. * High Risk: if there are 2 or more categories where the score is positive. * Low Risk: if there is only 1 or no categories where the score is positive. Scoring Categories: * Category 1 is positive with 2 or more positive responses to questions 2-6 * Category 2 is positive with 2 or more positive responses to questions 7-9 * Category 3 is positive with 1 positive response and a BMI\>30
Time frame: baseline and at 6 month
Blood pressure
Blood pressure measurements: systolic blood pressure and diastolic blood pressure
Time frame: baseline and at 6 month
Anthropometric variables (Body mass index)
Body mass index
Time frame: baseline and at 6 month
Quality of life (EuroQOL test)
Evaluate by EuroQOL test, is a standardised measure of health status. Description of the state of health in five dimensions (mobility, self-car, usual activities, pain/discomfort and anxiety/depression), each o wich is defined with three levels of severity, as measured by a Likert scale type (no problems, some problems and many problems or inability to activity).
Time frame: baseline and at 6 month
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Hospital Universitario Araba