Sleep Thermography for Diagnosis of Obstructive Sleep Apnea (TERMOAPNEA)

  • STATUS
    Recruiting
  • End date
    Sep 26, 2023
  • participants needed
    198
  • sponsor
    Hospital Universitario Araba
Updated on 26 September 2021

Summary

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

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.

Details
Condition obstructive sleep apnoea, obstructive sleep apnea syndrome, Obstructive sleep apnea
Treatment Therapeutic decision, Therapeutic decision PSG, Therapeutic decision Infrared thermgraphy system
Clinical Study IdentifierNCT04206449
SponsorHospital Universitario Araba
Last Modified on26 September 2021

Eligibility

Yes No Not Sure

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 C at the time of testing
Patient with malformation syndromes, Down syndrome and neuromuscular diseases
Patient on active treatment with Positive continuous pressure (CPAP )
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