Trials / Completed
CompletedNCT04206449
Sleep Thermography for Diagnosis of Obstructive Sleep Apnea (TERMOAPNEA)
Sleep Thermography for Diagnosis of Obstructive Sleep Apnea (OSA)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 198 (actual)
- Sponsor
- Hospital Universitario Araba · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Therapeutic decision PSG | Randomizing for therapeutic decision taken with Standard Polysomnography (PSG) |
| OTHER | Therapeutic decision Infrared thermgraphy system | Also randomizing for Infrared thermography system |
Timeline
- Start date
- 2018-09-10
- Primary completion
- 2022-06-07
- Completion
- 2022-06-07
- First posted
- 2019-12-20
- Last updated
- 2023-04-03
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT04206449. Inclusion in this directory is not an endorsement.