Sleep Thermography for Diagnosis of Obstructive Sleep Apnea (TERMOAPNEA)

Obstructive Sleep Apnea (OSA) Clinical Trial

— TERMOAPNEA  

Official title:

Sleep Thermography for Diagnosis of Obstructive Sleep Apnea (OSA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04206449
• Other study ID #: PI17/02011
• Status: Completed
• Phase: N/A
• Start date: September 10, 2018
• Est. completion date: June 7, 2022

Study information

• Verified date: March 2023
• Source: Hospital Universitario Araba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: June 7, 2022
• Est. primary completion date: June 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 )

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea (OSA)
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• Therapeutic decision PSG
Randomizing for therapeutic decision taken with Standard Polysomnography (PSG)
• Therapeutic decision Infrared thermgraphy system
Also randomizing for Infrared thermography system

Locations

Country	Name	City	State
Spain	Hospital Universitario Araba	Gasteiz / Vitoria	Araba

Sponsors (4)

Lead Sponsor	Collaborator
Hospital Universitario Araba	Bioraba, Ibermática/i3B, Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

References & Publications (19)

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Arch Bronconeumol. 2011 Jul;47(7):378. English, Spanish. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	6 month
Secondary	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).	6 month
Secondary	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.	baseline and at 6 month
Secondary	STOP-Bang Questionnaire	The questionnaire screens for obstructive sleep apnea (OSA): Low risk of OSA: <3; High risk of OSA: =3	baseline and at 6 month
Secondary	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	baseline and at 6 month
Secondary	Blood pressure	Blood pressure measurements: systolic blood pressure and diastolic blood pressure	baseline and at 6 month
Secondary	Anthropometric variables (Body mass index)	Body mass index	baseline and at 6 month
Secondary	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).	baseline and at 6 month