Apnea SyndromeAMANDANCT05908188
Analysis of Mandibular Movements in Ventilated Children With Sleep Apnea Syndrome
An observational study of Apnea Syndrome and Obstructive Sleep Apnea, run by University Hospital, Grenoble at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Apnea Syndrome, Obstructive Sleep Apnea
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 15 Feb 2023to Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Grenoble University Hospital
Grenoble
Guillaume Mortamet, PhD
About this study
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.
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.
Read the detailed 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.
- Conditions
- Apnea Syndrome, Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, apnea syndrome, children, continuous positive pressure, non invasive ventilation
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (3)
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
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start15 Feb 2023
- Primary completion1 Sep 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Apnea SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume Mortamet, MD, Principal investigator, Grenoble Alpes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908188
- Sponsor's protocol ID
- 2021-A02697-34
- Acronym
- AMANDA
- Status last verified
- Feb 2023
- First submitted
- 20 Dec 2021
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26541535Lescanne 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.
PubMed 23078979Redline 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.
PubMed 10228121Aubertin 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.
PubMed 27769627Abrahamyan 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.
PubMed 29318566Uddin 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.
PubMed 29446755Lapina 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.
PubMed 2985349Gray 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.
PubMed 28198129Obermeyer 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.
PubMed 27682033Amaddeo 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.
PubMed 25541022Pepin 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.
PubMed 31968116Martinot 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.
PubMed 25766710Berry 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.
PubMed 23066376Amaddeo 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.
PubMed 30070059Amaddeo 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.
PubMed 27423917
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05908188
- Acronym / sponsor ID
- AMANDA / 2021-A02697-34
- Conditions
- Apnea Syndrome, Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, apnea syndrome, children, continuous positive pressure, non invasive ventilation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: 1 year
during one night in hospital and one night at home
3 secondary outcomes
Residual obstructive airway events detected by mandibular movements and integrated continuous positive pressure or non invasive ventilation monitoring software.
Time frame: 1 year
The Obstructive Respiratory disturbance Index (ORDI) reproductibility
Time frame: 1 year
The difference in the Obstructive Respiratory disturbance Index (ORDI) before and after the modification of ventilatory parameters
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Background: PubMed 26541535Kaditis 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.
- Background: PubMed 23078979Lescanne 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.
- Background: PubMed 10228121Redline 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.
- Background: PubMed 27769627Aubertin 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.
- Background: PubMed 29318566Abrahamyan 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.
- Background: PubMed 29446755Uddin 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.
- Background: PubMed 2985349Lapina 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.
- Background: PubMed 28198129Gray 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.
- Background: PubMed 27682033Obermeyer 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.
- Background: PubMed 25541022Amaddeo 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.
- Background: PubMed 31968116Pepin 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.
- Background: PubMed 25766710Martinot 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.
- Individual participant dataSharing planned: No
Related trials for Apnea Syndrome
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Recruiting
Janus II Feasibility
Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume Mortamet, MD principal investigator
Grenoble Alpes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Apnea Syndrome and Obstructive Sleep Apnea, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guillaume Mortamet, MD (+33 4 76 76 55 03, gmortamet@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05908188, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.