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Completed

NCT Number: NCT04206449

Sleep Thermography for Diagnosis of Obstructive Sleep Apnea (TERMOAPNEA)

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

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Key information

Conditions

Obstructive Sleep Apnea (OSA) Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Araba

Vitoria-Gasteiz, Araba, 01009, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 )

Treatment and study plan

Therapeutic decision PSG

Other

Randomizing for therapeutic decision taken with Standard Polysomnography (PSG)

Therapeutic decision Infrared thermgraphy system

Other

Also randomizing for Infrared thermography system

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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

  5. 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

  6. Blood pressure

    Time frame: baseline and at 6 month

    Blood pressure measurements: systolic blood pressure and diastolic blood pressure

  7. Anthropometric variables (Body mass index)

    Time frame: baseline and at 6 month

    Body mass index

  8. 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).

Sponsors and collaborators

Lead sponsor

Hospital Universitario Araba

Other

Collaborators

  • Bioaraba Health Research Institute
  • Ibermática/i3B
  • Instituto de Salud Carlos III

Registry information

Official study title

Sleep Thermography for Diagnosis of Obstructive Sleep Apnea (OSA)

Acronym: TERMOAPNEA

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Dec 20, 2019
Registry last updated
Apr 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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