Analysis of Mandibular Movements in Ventilated Children With Sleep Apnea Syndrome

Obstructive Sleep Apnea Clinical Trial

— AMANDA  

Official title:

Analysis of Mandibular Movements to Optimize Ventilatory Management of Children With Obstructive Sleep Apnea Syndrome Treated With Continuous Positive Airway Pressure or Non-Invasive Ventilation.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05908188
• Other study ID #: 2021-A02697-34
• Status: Recruiting
• Start date: February 15, 2023
• Est. completion date: September 2023

Study information

• Verified date: February 2023
• Source: University Hospital, Grenoble
• Contact: Guillaume Mortamet, MD
• Phone: +33 4 76 76 55 03
• Email: gmortamet[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Obstructive Sleep Apnea is a common medical condition in children. Diagnosis is based on polysomnography . We conducted an open prospective non randomised clinical trial to assess the efficacy of a new medical device called SUNRISE.

Description:

Obstructive Sleep apnea affects 4 percent of children. The standard device for the diagnosis and follow up is the polysomnography (PSG). However acess for this technique is difficult and expensive in certain institutions . Moreover, not all centers are qualified to receive the pediatric population. Thus expert consensus is present on the need for the development of a less expensive and easily accessible device to ensure the equality in medical care.

Recently an innovative medical device utilising the artificial intelligence technology is used to diagnose OSA in adults by recording the mandibular movement. Martinot et al were the first to use this device in children and noted a correlation between the mandibular movements and polysomnography measurements.

A multidisciplinary approach is used in the treatment of OSA. Indeed, the treatment is based on continous positive pressure and non invasive ventilation. To better evaluate the treatment, the sensor can be an alternative allowing to analyze the mandibular movements without moving at home.

We conducted an open prospective non randomised clinical trial to assess the efficacy of a new medical device called "SUNRISE" in the diagnosis and monitoring of OSA.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

Inclusion Criteria:

• Children aged 5-18 years inclusive.

• With a diagnosis of severe OSA diagnosed at PSG, defined by an apnoea-hypopnoea index = 10/ hours or an apnoea index = 5/ hours, and associated or not with alveolar hypoventilation.

• Ventilated with noninvaisve ventilation or continuous positive airway pressure during sleep.

• With a nasal or nostril interface.

• Followed in one of the 2 participating centres: the Grenoble-Alpes University Hospital or the Trousseau Hospital in Paris.

Exclusion Criteria:

• Patients with centrally-induced sleep apnoea syndrome.

• Patients at the end of life or for whom limitation of active therapies has been established.

• Patients ventilated with a naso-oral interface.

Related Conditions & MeSH terms

• Apnea
• Apnea Syndrome
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Locations

Country	Name	City	State
France	Grenoble University Hospital	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (16)

Abrahamyan L, Sahakyan Y, Chung S, Pechlivanoglou P, Bielecki J, Carcone SM, Rac VE, Fitzpatrick M, Krahn M. Diagnostic accuracy of level IV portable sleep monitors versus polysomnography for obstructive sleep apnea: a systematic review and meta-analysis. Sleep Breath. 2018 Sep;22(3):593-611. doi: 10.1007/s11325-017-1615-1. Epub 2018 Jan 9. — View Citation

Amaddeo A, Caldarelli V, Fernandez-Bolanos M, Moreau J, Ramirez A, Khirani S, Fauroux B. Polygraphic respiratory events during sleep in children treated with home continuous positive airway pressure: description and clinical consequences. Sleep Med. 2015 Jan;16(1):107-12. doi: 10.1016/j.sleep.2014.07.030. Epub 2014 Nov 18. — View Citation

Amaddeo A, Frapin A, Fauroux B. Long-term non-invasive ventilation in children. Lancet Respir Med. 2016 Dec;4(12):999-1008. doi: 10.1016/S2213-2600(16)30151-5. Epub 2016 Jul 13. — View Citation

Amaddeo A, Frapin A, Touil S, Khirani S, Griffon L, Fauroux B. Outpatient initiation of long-term continuous positive airway pressure in children. Pediatr Pulmonol. 2018 Oct;53(10):1422-1428. doi: 10.1002/ppul.24138. Epub 2018 Aug 1. — View Citation

Amaddeo A, Khirani S, Griffon L, Teng T, Lanzeray A, Fauroux B. Non-invasive Ventilation and CPAP Failure in Children and Indications for Invasive Ventilation. Front Pediatr. 2020 Oct 26;8:544921. doi: 10.3389/fped.2020.544921. eCollection 2020. — View Citation

Aubertin G, Schroder C, Sevin F, Clouteau F, Lamblin MD, Vecchierini MF. [Obstructive sleep apnea-hypopnea syndrome in children: Clinical diagnosis]. Arch Pediatr. 2017 Feb;24 Suppl 1:S7-S15. doi: 10.1016/j.arcped.2016.09.002. Epub 2016 Oct 18. French. — View Citation

Berry RB, Budhiraja R, Gottlieb DJ, Gozal D, Iber C, Kapur VK, Marcus CL, Mehra R, Parthasarathy S, Quan SF, Redline S, Strohl KP, Davidson Ward SL, Tangredi MM; American Academy of Sleep Medicine. Rules for scoring respiratory events in sleep: update of the 2007 AASM Manual for the Scoring of Sleep and Associated Events. Deliberations of the Sleep Apnea Definitions Task Force of the American Academy of Sleep Medicine. J Clin Sleep Med. 2012 Oct 15;8(5):597-619. doi: 10.5664/jcsm.2172. — View Citation

Gray EL, Barnes DJ. Beyond the thermistor: Novel technology for the ambulatory diagnosis of obstructive sleep apnoea. Respirology. 2017 Apr;22(3):418-419. doi: 10.1111/resp.13004. Epub 2017 Feb 14. No abstract available. — View Citation

Kaditis AG, Alonso Alvarez ML, Boudewyns A, Alexopoulos EI, Ersu R, Joosten K, Larramona H, Miano S, Narang I, Trang H, Tsaoussoglou M, Vandenbussche N, Villa MP, Van Waardenburg D, Weber S, Verhulst S. Obstructive sleep disordered breathing in 2- to 18-year-old children: diagnosis and management. Eur Respir J. 2016 Jan;47(1):69-94. doi: 10.1183/13993003.00385-2015. Epub 2015 Nov 5. — View Citation

Lapina VA, Dontsov AE, Ostrovskii MA, Emanuel' NM. [Interaction of oxygen anion radicals with eye melanins and ommochromes]. Dokl Akad Nauk SSSR. 1985;280(6):1463-5. No abstract available. Russian. — View Citation

Lescanne E, Chiron B, Constant I, Couloigner V, Fauroux B, Hassani Y, Jouffroy L, Lesage V, Mondain M, Nowak C, Orliaguet G, Viot A; French Society of ENT (SFORL); French Association for Ambulatory Surgery (AFCA); French Society for Anaesthesia, Intensive Care (SFAR). Pediatric tonsillectomy: clinical practice guidelines. Eur Ann Otorhinolaryngol Head Neck Dis. 2012 Oct;129(5):264-71. doi: 10.1016/j.anorl.2012.03.003. Epub 2012 Oct 15. — View Citation

Martinot JB, Senny F, Denison S, Cuthbert V, Gueulette E, Guenard H, Pepin JL. Mandibular movements identify respiratory effort in pediatric obstructive sleep apnea. J Clin Sleep Med. 2015 Apr 15;11(5):567-74. doi: 10.5664/jcsm.4706. — View Citation

Obermeyer Z, Emanuel EJ. Predicting the Future - Big Data, Machine Learning, and Clinical Medicine. N Engl J Med. 2016 Sep 29;375(13):1216-9. doi: 10.1056/NEJMp1606181. No abstract available. — View Citation

Pepin JL, Letesson C, Le-Dong NN, Dedave A, Denison S, Cuthbert V, Martinot JB, Gozal D. Assessment of Mandibular Movement Monitoring With Machine Learning Analysis for the Diagnosis of Obstructive Sleep Apnea. JAMA Netw Open. 2020 Jan 3;3(1):e1919657. doi: 10.1001/jamanetworkopen.2019.19657. — View Citation

Redline S, Tishler PV, Schluchter M, Aylor J, Clark K, Graham G. Risk factors for sleep-disordered breathing in children. Associations with obesity, race, and respiratory problems. Am J Respir Crit Care Med. 1999 May;159(5 Pt 1):1527-32. doi: 10.1164/ajrccm.159.5.9809079. — View Citation

Uddin MB, Chow CM, Su SW. Classification methods to detect sleep apnea in adults based on respiratory and oximetry signals: a systematic review. Physiol Meas. 2018 Mar 26;39(3):03TR01. doi: 10.1088/1361-6579/aaafb8. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concomitant detection of residual obstructive breathing events by mandibular movements recorded by the sensor in comparison with a complete polysomnography recording performed in hospital under continuous positive pressure or non invasive ventilation	during one night in hospital and one night at home	1 year
Secondary	Residual obstructive airway events detected by mandibular movements and integrated continuous positive pressure or non invasive ventilation monitoring software.	the number of apnea and obstructive hypopnea per hour	1 year
Secondary	The Obstructive Respiratory disturbance Index (ORDI) reproductibility	To compare the Obstructive Respiratory disturbance Index (ORDI) (defined as the number of obstructive apneas, hypopneas, and flow limitation events per hour) calculated during the hospital recording and that calculated during the home recording.	1 year
Secondary	The difference in the Obstructive Respiratory disturbance Index (ORDI) before and after the modification of ventilatory parameters	The difference between the ORDI ((defined as the number of obstructive apneas, hypopneas, and flow limitation events per hour) at hospital recording and at home recording.	1 year