Sleep Thermography for Diagnosis of Obstructive Sleep Apnea (TERMOAPNEA)

Study Overview
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Brief Summary
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To assess the diagnostic validity and cost-effectiveness of an infrared thermography system in adults with clinical suspicion of Obstructive Sleep Apnea (OSA).

Detailed Description
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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.

Official Title
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Sleep Thermography for Diagnosis of Obstructive Sleep Apnea (OSA)

Conditions
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Obstructive Sleep Apnea (OSA)

Intervention / Treatment
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* Other: Therapeutic decision PSG
* Other: Therapeutic decision Infrared thermgraphy system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women over 18 years to 75 years old, with clinical suspicion of OSA Written informed consent signed Exclusion Criteria: Place of residence more than 100 km from the hospital Severe, unstable or exacerbated cardio-vascular, cerebro-vascular or respiratory disease, that makes it impossible to carry out adequate studies Presence of insomnia, depressive syndrome or epilepsia Patients diagnosed of any acute inflammatory episode of the cranium-maxillo-facial area or any systemic infection that develops with fever> 38 ºC at the time of testing Patient with malformation syndromes, Down syndrome and neuromuscular diseases Patient on active treatment with Positive continuous pressure (CPAP )

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infrared thermography system<br>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<br>* Also randomizing for Infrared thermography system<br>|
| Active Comparator: Standard Polysomnography (PSG)<br>Therapeutic decision taken with Standard Polysomnography (PSG), to determine the sleep stages and Apnea-Hypopnea Index (AHI) | Other: Therapeutic decision PSG<br>* Randomizing for therapeutic decision taken with Standard Polysomnography (PSG)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 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. | 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 | 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 | baseline and at 6 month | 
| Blood pressure | Blood pressure measurements: systolic blood pressure and diastolic blood pressure | baseline and at 6 month | 
| Anthropometric variables (Body mass index) | Body mass index | 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). | baseline and at 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infrared thermography system, Standard Polysomnography, Validity, Cost-effectiveness