NCT05908188

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2021

Completed
1.2 years until next milestone

Study Start

First participant enrolled

February 15, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

June 18, 2023

Status Verified

February 1, 2023

Enrollment Period

7 months

First QC Date

December 20, 2021

Last Update Submit

June 8, 2023

Conditions

Apnea SyndromeObstructive Sleep Apnea

Keywords

obstructive sleep apneaapnea syndromechildrencontinuous positive pressurenon invasive ventilation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Residual obstructive airway events detected by mandibular movements and integrated continuous positive pressure or non invasive ventilation monitoring software.

    1 year

  • The Obstructive Respiratory disturbance Index (ORDI) reproductibility

    1 year

  • The difference in the Obstructive Respiratory disturbance Index (ORDI) before and after the modification of ventilatory parameters

    1 year

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

My population consists of children aged between 5 and 18 years old with obstructive sleep apnea syndrome and treated with positive pressure ventilation and non invasive ventilation.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grenoble University Hospital

Grenoble, France

RECRUITING

Related Publications (16)

  • 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.

    PMID: 26541535BACKGROUND

  • 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.

    PMID: 23078979BACKGROUND

  • 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.

    PMID: 10228121BACKGROUND

  • 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.

    PMID: 27769627BACKGROUND

  • 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.

    PMID: 29318566BACKGROUND

  • 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.

    PMID: 29446755BACKGROUND

  • 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.

    PMID: 2985349BACKGROUND

  • 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.

    PMID: 28198129BACKGROUND

  • 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.

    PMID: 27682033BACKGROUND

  • 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.

    PMID: 25541022BACKGROUND

  • 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.

    PMID: 31968116BACKGROUND

  • 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.

    PMID: 25766710BACKGROUND

  • 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.

    PMID: 23066376BACKGROUND

  • 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.

    PMID: 30070059BACKGROUND

  • 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.

    PMID: 27423917BACKGROUND

  • 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.

    PMID: 33194886BACKGROUND

MeSH Terms

Conditions

Sleep Apnea SyndromesSleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Guillaume Mortamet, MD

    Grenoble Alpes University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillaume Mortamet, MD

CONTACT

+33 4 76 76 55 03gmortamet@chu-grenoble.fr

Guillaume Aubertin, MD

CONTACT

+33 1 88 32 00 00guillaume.aubertin@aphp.fr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2021

First Posted

June 18, 2023

Study Start

February 15, 2023

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

June 18, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)