Sleep Thermography for Diagnosis of Obstructive Sleep Apnea (TERMOAPNEA)
NCT ID: NCT04206449
Last Updated: 2023-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
198 participants
INTERVENTIONAL
2018-09-10
2022-06-07
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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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).
Therapeutic decision Infrared thermgraphy system
Also randomizing for Infrared thermography system
Standard Polysomnography (PSG)
Therapeutic decision taken with Standard Polysomnography (PSG), to determine the sleep stages and Apnea-Hypopnea Index (AHI)
Therapeutic decision PSG
Randomizing for therapeutic decision taken with Standard Polysomnography (PSG)
Interventions
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Therapeutic decision PSG
Randomizing for therapeutic decision taken with Standard Polysomnography (PSG)
Therapeutic decision Infrared thermgraphy system
Also randomizing for Infrared thermography system
Eligibility Criteria
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Inclusion Criteria
* Written informed consent signed
Exclusion Criteria
* 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 )
18 Years
75 Years
ALL
No
Sponsors
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Ibermática/i3B
UNKNOWN
Instituto de Salud Carlos III
OTHER_GOV
Bioraba
UNKNOWN
Hospital Universitario Araba
OTHER
Responsible Party
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Carlos Javier Egea Santaolalla,Ph
Principal Investigator, MD, PhD
Principal Investigators
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Joaquin Duran-Cantolla, MD
Role: STUDY_DIRECTOR
Hospital Universitario Araba
Locations
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Hospital Universitario Araba
Vitoria-Gasteiz, Araba, Spain
Countries
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References
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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.
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.
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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.
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.
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.
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.
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.
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.
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.
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.
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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.
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van den Heuvel CJ, Ferguson SA, Dawson D, Gilbert SS. Comparison of digital infrared thermal imaging (DITI) with contact thermometry: pilot data from a sleep research laboratory. Physiol Meas. 2003 Aug;24(3):717-25. doi: 10.1088/0967-3334/24/3/308.
Other Identifiers
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PI17/02011
Identifier Type: -
Identifier Source: org_study_id
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