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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
198
Randomizing for therapeutic decision taken with Standard Polysomnography (PSG)
Also randomizing for Infrared thermography system
Hospital Universitario Araba
Vitoria-Gasteiz, Araba, Spain
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
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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