Sleep Thermography for Diagnosis of Obstructive Sleep Apnea (TERMOAPNEA) (TERMOAPNEA)

March 31, 2023 updated by: Carlos Javier Egea Santaolalla,Ph, Hospital Universitario Araba

Sleep Thermography for Diagnosis of Obstructive Sleep Apnea (OSA)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

198

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Araba
      • Gasteiz / Vitoria, Araba, Spain, 01009
        • Hospital Universitario Araba

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 )

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apnea-Hypopnea Index (AHI)
Time Frame: Baseline
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
Time Frame: 6 month
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
Time Frame: 6 month
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
Time Frame: baseline and at 6 month
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
Time Frame: baseline and at 6 month

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
Time Frame: baseline and at 6 month

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
Time Frame: baseline and at 6 month
Blood pressure measurements: systolic blood pressure and diastolic blood pressure
baseline and at 6 month
Anthropometric variables (Body mass index)
Time Frame: baseline and at 6 month
Body mass index
baseline and at 6 month
Quality of life (EuroQOL test)
Time Frame: baseline and at 6 month
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Araba

Collaborators

Instituto de Salud Carlos III
Ibermática/i3B
Bioraba

Investigators

  • Study Director: Joaquin Duran-Cantolla, MD, Hospital Universitario Araba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2018

Primary Completion (Actual)

June 7, 2022

Study Completion (Actual)

June 7, 2022

Study Registration Dates

First Submitted

November 6, 2019

First Submitted That Met QC Criteria

December 18, 2019

First Posted (Actual)

December 20, 2019

Study Record Updates

Last Update Posted (Actual)

April 3, 2023

Last Update Submitted That Met QC Criteria

March 31, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI17/02011

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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