Sleep Thermography for Diagnosis of Obstructive Sleep Apnea (TERMOAPNEA)

NCT04206449 | Completed

• 1 other identifier: PI17/02011
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obstructive Sleep Apnea (OSA)

Keywords

Infrared thermography system; Standard Polysomnography; Validity; Cost-effectiveness

Outcome Measures

Primary Outcomes (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).

  Baseline

Secondary Outcomes (8)

• Validation of the therapeutic decision

  6 month

• Cost effectiveness analysis

  6 month

• Epworth Sleepiness Scale

  baseline and at 6 month

• STOP-Bang Questionnaire

  baseline and at 6 month

• Berlin questionnaire

  baseline and at 6 month

Study Arms (2)

Infrared thermography system

EXPERIMENTAL

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

Standard Polysomnography (PSG)

ACTIVE COMPARATOR

Therapeutic decision taken with Standard Polysomnography (PSG), to determine the sleep stages and Apnea-Hypopnea Index (AHI)

Other: Therapeutic decision PSG

Interventions

Therapeutic decision PSG OTHER

Randomizing for therapeutic decision taken with Standard Polysomnography (PSG)

Standard Polysomnography (PSG)

Therapeutic decision Infrared thermgraphy system OTHER

Also randomizing for Infrared thermography system

Infrared thermography system

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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 )

Sponsors & Collaborators

• Hospital Universitario Araba: lead
• Ibermática/i3B: collaborator
• Instituto de Salud Carlos III: collaborator
• Bioraba: collaborator

Study Sites (1)

Hospital Universitario Araba

Vitoria-Gasteiz, Araba, 01009, Spain

Location

Related Publications (19)

• 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.

  BACKGROUND

• 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.

  PMID: 21398016 BACKGROUND

• 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.

  PMID: 11254524 BACKGROUND

• 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.

  PMID: 8464434 BACKGROUND

• 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.

  PMID: 15161592 BACKGROUND

• 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.

  PMID: 19688045 BACKGROUND

• 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.

  PMID: 18198809 BACKGROUND

• 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.

  PMID: 16171294 BACKGROUND

• 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.

  PMID: 17283346 BACKGROUND

• 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.

  PMID: 19960649 BACKGROUND

• 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.

  PMID: 10841209 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 9785270 BACKGROUND

• 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.

  PMID: 15033148 BACKGROUND

• 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.

  PMID: 17070562 BACKGROUND

• Parmeggiani PL, Agnati LF, Zamboni G, Cianci T. Hypothalamic temperature during the sleep cycle at different ambient temperatures. Electroencephalogr Clin Neurophysiol. 1975 Jun;38(6):589-96. doi: 10.1016/0013-4694(75)90159-5.

  PMID: 50184 BACKGROUND

• Montgomery I, Trinder J, Paxton S, Harris D, Fraser G, Colrain I. Physical exercise and sleep: the effect of the age and sex of the subjects and type of exercise. Acta Physiol Scand Suppl. 1988;574:36-40.

  PMID: 3245465 BACKGROUND

• Lack LC, Gradisar M, Van Someren EJ, Wright HR, Lushington K. The relationship between insomnia and body temperatures. Sleep Med Rev. 2008 Aug;12(4):307-17. doi: 10.1016/j.smrv.2008.02.003.

  PMID: 18603220 BACKGROUND

• 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.

  PMID: 14509309 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Joaquin Duran-Cantolla, MD

  Hospital Universitario Araba

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD, PhD

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: December 20, 2019
• Study Start: September 10, 2018
• Primary Completion: June 7, 2022
• Study Completion: June 7, 2022
• Last Updated: April 3, 2023

Record last verified: 2023-03

Locations

ES (1)