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Obstructive Sleep Apnea (OSA)TERMOAPNEANCT04206449

Sleep Thermography for Diagnosis of Obstructive Sleep Apnea (TERMOAPNEA)

A study testing Therapeutic decision PSG and Therapeutic decision Infrared thermgraphy system in people with Obstructive Sleep Apnea (OSA), run by Hospital Universitario Araba at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Obstructive Sleep Apnea (OSA)
What is being tested?
Therapeutic decision PSG and Therapeutic decision Infrared thermgraphy system
Could I receive a placebo?
No, everyone receives an active treatment
How many people
198 participants
Where
1 siteSpain
Study dates
10 Sep 2018to 7 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women over 18 years to 75 years old, with clinical suspicion of OSA
  • Written informed consent signed

Who cannot join

  • 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 )

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Universitario Araba

    Vitoria-Gasteiz, Araba, 01009

Other trials in Spain

About this study

Official title: 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).

Read the 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.

Being tested
Therapeutic decision PSG, Therapeutic decision Infrared thermgraphy system
Keywords
Infrared thermography system, Standard Polysomnography, Validity, Cost-effectiveness
Medical subject headings
Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Therapeutic decision PSGOther

    Randomizing for therapeutic decision taken with Standard Polysomnography (PSG)

  • Therapeutic decision Infrared thermgraphy systemOther

    Also randomizing for Infrared thermography system

Study groups in NCT04206449
Study groupRoleWhat they receive
Infrared thermography systemExperimentalTherapeutic decision taken with infrared thermography system, integrated in an expert diagnostic algorithm (TIS), to determine the sleep stages and Apnea-Hypopnea Index (AHI).
Receives: Other: Therapeutic decision Infrared thermgraphy system
Standard Polysomnography (PSG)Active comparatorTherapeutic decision taken with Standard Polysomnography (PSG), to determine the sleep stages and Apnea-Hypopnea Index (AHI)
Receives: Other: Therapeutic decision PSG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Apnea-Hypopnea Index (AHI)

    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).

    Measured: Baseline

Secondary outcomes (8)

  1. Validation of the therapeutic decision

    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.

    Measured: 6 month

  2. Cost effectiveness analysis

    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).

    Measured: 6 month

  3. Epworth Sleepiness Scale

    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.

    Measured: baseline and at 6 month

  4. STOP-Bang Questionnaire

    The questionnaire screens for obstructive sleep apnea (OSA):

    • Low risk of OSA: <3
    • High risk of OSA: ≥3

    Measured: baseline and at 6 month

  5. Berlin questionnaire

    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

    Measured: baseline and at 6 month

  6. Blood pressure

    Blood pressure measurements: systolic blood pressure and diastolic blood pressure

    Measured: baseline and at 6 month

  7. Anthropometric variables (Body mass index)

    Body mass index

    Measured: baseline and at 6 month

  8. Quality of life (EuroQOL test)

    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).

    Measured: baseline and at 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2019
  2. Study start10 Sep 2018
  3. Primary completion7 Jun 2022
  4. Study completion7 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
198 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04206449
Sponsor's protocol ID
PI17/02011
Acronym
TERMOAPNEA
Status last verified
Mar 2023
First submitted
6 Nov 2019
Last updated
3 Apr 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Durán-Cantolla J, Puertas FJ, Pin G y el Grupo Español de Sueño (GES).Documento de consenso nacional sobre el SAHS. Arch Bronconumol 2005;41(nº4):1-110.

  • Lloberes P, Duran-Cantolla J, Martinez-Garcia MA, Marin JM, Ferrer A, Corral J, Masa JF, Parra O, Alonso-Alvarez ML, Teran-Santos J. Diagnosis and treatment of sleep apnea-hypopnea syndrome. Spanish Society of Pulmonology and Thoracic Surgery. Arch Bronconeumol. 2011 Mar;47(3):143-56. doi: 10.1016/j.arbres.2011.01.001. No abstract available. English, Spanish.

    PubMed 21398016

  • Duran J, Esnaola S, Rubio R, Iztueta A. Obstructive sleep apnea-hypopnea and related clinical features in a population-based sample of subjects aged 30 to 70 yr. Am J Respir Crit Care Med. 2001 Mar;163(3 Pt 1):685-9. doi: 10.1164/ajrccm.163.3.2005065.

    PubMed 11254524

  • Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. doi: 10.1056/NEJM199304293281704.

    PubMed 8464434

  • Duran-Cantolla J, Mar J, de La Torre Munecas G, Rubio Aramendi R, Guerra L. [The availability in Spanish public hospitals of resources for diagnosing and treating sleep apnea-hypopnea syndrome]. Arch Bronconeumol. 2004 Jun;40(6):259-67. doi: 10.1016/s1579-2129(06)70096-9. Spanish.

    PubMed 15161592

  • Punjabi NM, Caffo BS, Goodwin JL, Gottlieb DJ, Newman AB, O'Connor GT, Rapoport DM, Redline S, Resnick HE, Robbins JA, Shahar E, Unruh ML, Samet JM. Sleep-disordered breathing and mortality: a prospective cohort study. PLoS Med. 2009 Aug;6(8):e1000132. doi: 10.1371/journal.pmed.1000132. Epub 2009 Aug 18.

    PubMed 19688045

  • Collop NA, Anderson WM, Boehlecke B, Claman D, Goldberg R, Gottlieb DJ, Hudgel D, Sateia M, Schwab R; Portable Monitoring Task Force of the American Academy of Sleep Medicine. Clinical guidelines for the use of unattended portable monitors in the diagnosis of obstructive sleep apnea in adult patients. Portable Monitoring Task Force of the American Academy of Sleep Medicine. J Clin Sleep Med. 2007 Dec 15;3(7):737-47.

    PubMed 18198809

  • Kushida CA, Littner MR, Morgenthaler T, Alessi CA, Bailey D, Coleman J Jr, Friedman L, Hirshkowitz M, Kapen S, Kramer M, Lee-Chiong T, Loube DL, Owens J, Pancer JP, Wise M. Practice parameters for the indications for polysomnography and related procedures: an update for 2005. Sleep. 2005 Apr;28(4):499-521. doi: 10.1093/sleep/28.4.499.

    PubMed 16171294

  • Mulgrew AT, Fox N, Ayas NT, Ryan CF. Diagnosis and initial management of obstructive sleep apnea without polysomnography: a randomized validation study. Ann Intern Med. 2007 Feb 6;146(3):157-66. doi: 10.7326/0003-4819-146-3-200702060-00004.

    PubMed 17283346

  • Epstein LJ, Kristo D, Strollo PJ Jr, Friedman N, Malhotra A, Patil SP, Ramar K, Rogers R, Schwab RJ, Weaver EM, Weinstein MD; Adult Obstructive Sleep Apnea Task Force of the American Academy of Sleep Medicine. Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults. J Clin Sleep Med. 2009 Jun 15;5(3):263-76.

    PubMed 19960649

  • Van Someren EJ. More than a marker: interaction between the circadian regulation of temperature and sleep, age-related changes, and treatment possibilities. Chronobiol Int. 2000 May;17(3):313-54. doi: 10.1081/cbi-100101050.

    PubMed 10841209

  • Parmeggiani PL. Thermoregulation during sleep from the view point of homeostasis. Clinical Physiology of Sleep, American Physiological Society 1988, pp 159-69.

  • van den Heuvel CJ, Noone JT, Lushington K, Dawson D. Changes in sleepiness and body temperature precede nocturnal sleep onset: evidence from a polysomnographic study in young men. J Sleep Res. 1998 Sep;7(3):159-66. doi: 10.1046/j.1365-2869.1998.00112.x.

    PubMed 9785270

  • Gilbert SS, van den Heuvel CJ, Ferguson SA, Dawson D. Thermoregulation as a sleep signalling system. Sleep Med Rev. 2004 Apr;8(2):81-93. doi: 10.1016/S1087-0792(03)00023-6.

    PubMed 15033148

  • Raymann RJ, Swaab DF, Van Someren EJ. Skin temperature and sleep-onset latency: changes with age and insomnia. Physiol Behav. 2007 Feb 28;90(2-3):257-66. doi: 10.1016/j.physbeh.2006.09.008. Epub 2006 Oct 27.

    PubMed 17070562

Questions about this trial

What is this clinical trial studying?

A study testing Therapeutic decision PSG and Therapeutic decision Infrared thermgraphy system in people with Obstructive Sleep Apnea (OSA), run by Hospital Universitario Araba at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Apnea-Hypopnea Index (AHI) (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04206449, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.

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