Clinical trial NCT04206449: Sleep Thermography for Diagnosis of Obstructive Sleep Apnea (TERMOAPNEA)
Official title: Sleep Thermography for Diagnosis of Obstructive Sleep Apnea (OSA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea (OSA)
Keywords: Infrared thermography system
Standard Polysomnography
Validity
Cost-effectiveness
Lead sponsor: Hospital Universitario Araba
Sponsor class: OTHER
Collaborators: name: Ibermática/i3B
name: Instituto de Salud Carlos III
name: Bioraba
First posted: 2019-12-20
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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 )

Primary outcomes:
measure: Apnea-Hypopnea Index (AHI)
timeFrame: Baseline
Secondary outcomes:
measure: Validation of the therapeutic decision
timeFrame: 6 month
measure: Cost effectiveness analysis
timeFrame: 6 month
measure: Epworth Sleepiness Scale
timeFrame: baseline and at 6 month
measure: STOP-Bang Questionnaire
timeFrame: baseline and at 6 month
measure: Berlin questionnaire
timeFrame: baseline and at 6 month
measure: Blood pressure
timeFrame: baseline and at 6 month
measure: Anthropometric variables (Body mass index)
timeFrame: baseline and at 6 month
measure: Quality of life (EuroQOL test)
timeFrame: baseline and at 6 month
Other outcomes:
Locations:
city: Gasteiz / Vitoria
country: Spain
facility: Hospital Universitario Araba
state: Araba
Study officials:
affiliation: Hospital Universitario Araba
name: Joaquin Duran-Cantolla, MD
role: STUDY_DIRECTOR
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