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AzTrials

Sleep Apnea Syndromes in ChildrenELIPSENCT06692660

Overview: Use of Respiratory Support At Home in Children

An observational study of Sleep Apnea Syndromes in Children and Obesity in Children, run by University Hospital, Grenoble at 2 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

the primary outcome is to describe the perceived success of the use of the respiratory support from the parent's point of view Read more about this study

Who is it for?
Ages 0 to 17 years
How many people
30 participants
Where
2 sitesFrance
Study dates
Nov 2024to Aug 2025
Phase
Observational
Are there results?
Not yet: the study is under way

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 0 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Our study population includes patients from the Grenoble Alpes Hospital, from 0 to 18 (not yet passed) years old. These patients benefit from respiratory support at home. Their follow-up is done at the Grenoble Alpes Hospital. We will not include patients who benefit from palliative care, invasive ventilation or high flow oxygen therapy.

Who may be able to join

  • Children with respiratory support at home
  • Age 0 to 18 (not yet passed) years old

Who cannot join

  • Palliative care
  • Invasive ventilation
  • High flow oxygen therapy

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Julie CASSIBBA, MD contact

+33476765566

jcassibba@chu-grenoble.fr

Camille BERTIN, Intern contact

+33660676532

cbertin1@chu-grenoble.fr

France2 sites

  • Centre Hospitalier Universitaire Grenoble Alpes

    Grenoble, Isère, 38100

  • Centre Hospitalier Grenoble Alpes

    La Tronche, 38700

    Eglantine HULLO, MD, +33(0)4 76 76 51 89, EHullo@chu-grenoble.fr

    Camille BERTIN, Intern, +33660676532, cbertin1@chu-grenoble.fr

Other trials in France

About this study

Official title: An Overview of the Use of Respiratory Support At Home in Children - Patients and Families Point of View

the primary outcome is to describe the perceived success of the use of the respiratory support from the parent's point of view

Read the detailed description

The use of ventilatory support, including CPAP (Continuous Positive Airway Pressure), which is a mode of ventilation with continuous positive pressure, and BiPAP (Bilevel Positive Airway Pressure), which is a mode of ventilation with two levels of pressure, has seen a significant increase in indications in recent years. The indications have become more numerous and increasingly complex. Sleep-related respiratory disorders, including obstructive sleep apnea-hypopnea syndrome, central apnea syndrome, and alveolar hypoventilation, are the primary reasons for these indications. In pediatrics, numerous conditions contribute to sleep-related respiratory disorders: ENT malformations, genetic conditions, obesity, bronchopulmonary dysplasia, neuromuscular diseases, thoracic deformities, and storage diseases.

The non-use or insufficient use of ventilatory support leads to a lack of treatment for sleep-related respiratory disorders. In the absence of treatment, the consequences are neurocognitive, cardiovascular, and metabolic, resulting in high morbidity. Non-use or insufficient use is a cause of failure of ventilatory support. Neither the use nor the failure of ventilatory support is clearly defined. It is crucial to evaluate the use of ventilatory support in order to correct factors related to non-use or insufficient use and to prevent the negative consequences resulting from unaddressed sleep-related respiratory disorders. This pilot study aims to assess the use of ventilatory support at home in pediatrics through interviews with patients and their parents. We will use a questionnaire designed for the study, consisting of 10 questions regarding sleep, symptoms, quality of life, technical issues, side effects, economic barriers, and adherence, to describe their experiences with ventilatory support.

Keywords
respiratory suport, sleep apnea syndrome, CPAP, BiPAP, ventilation, alveolar hypoventilation, non invasive ventilation
Medical subject headings
Pediatric Obesity, Bronchopulmonary Dysplasia, Neuromuscular Diseases, Congenital Abnormalities, Hypoventilation, Sleep Apnea Syndromes, Respiratory Aspiration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. describe the perceived success of the use of the respiratory support from the parent's point of view

    The primary outcome measure is the median score and interquartile range, obtained from the answer modalities according to the Likert scale (scores ranging from 1 to 5), in response to the question from the parent interview guide, which states: "Do you consider that the ventilatory support proposed for your child is a success? Please circle the corresponding score."

    Measured: Assessment during the filling of the questionnaire at enrollment

Secondary outcomes (6)

  1. Describe the persistence of symptoms under ventilatory support according to the parent.

    Answer to the question from the parent interview guide: "What symptoms did your child have before starting treatment? Have these symptoms improved?"

    Measured: Assessment during the filling of the questionnaire at enrollment

  2. Describe the persistence of symptoms under ventilatory support according to the child

    Answer to the question from the child interview guide: "Were you bothered before getting the machine? Is it better with the machine?"

    Measured: Assessment during the filling of the questionnaire at enrollment

  3. Describe the tolerance of ventilatory support according to the parent.

    Answer to the question from the parent interview guide: "Have you noticed any complications since your child started using the machine?"

    Measured: Assessment during the filling of the questionnaire at enrollment

  4. Describe the tolerance of ventilatory support according to the child.

    Answer to the question from the child interview guide: "Does the machine bother you?"

    Measured: Assessment during the filling of the questionnaire at enrollment

  5. Describe adherence to ventilatory support according to the parent.

    Answer to the question from the parent interview guide: "How many hours does your child use the machine at night? How many nights per week? Does your child use the machine when you go away for the weekend or on vacation...? If not, why?" For children aged 0-4 years: "Does the child wear it during naps? How many naps per week?"

    Measured: Assessment during the filling of the questionnaire at enrollment

  6. Describe adherence to ventilatory support according to the child.

    Answer to the question from the child interview guide: "Can you wear your machine all night? Every night? Do you wear your machine when you're not sleeping at home? If not, why? "

    Measured: Assessment during the filling of the questionnaire at enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2024
  2. Study startNov 2024 (estimated)
  3. Primary completionAug 2025 (estimated)
  4. Study completionAug 2025 (estimated)

Resources

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
Case only
Time perspective
Prospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06692660
Sponsor's protocol ID
2024-A01045-42
Acronym
ELIPSE
Status last verified
Nov 2024
First submitted
14 Nov 2024
Last updated
18 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 33194886

  • MacLean JE, Fauroux B. Long-term non-invasive ventilation in children: Transition from hospital to home. Paediatr Respir Rev. 2023 Sep;47:3-10. doi: 10.1016/j.prrv.2023.01.002. Epub 2023 Jan 12.

    PubMed 36806331

  • Ramirez A, Delord V, Khirani S, Leroux K, Cassier S, Kadlub N, Aubertin G, Picard A, Fauroux B. Interfaces for long-term noninvasive positive pressure ventilation in children. Intensive Care Med. 2012 Apr;38(4):655-62. doi: 10.1007/s00134-012-2516-1. Epub 2012 Mar 6.

    PubMed 22392032

  • McLaren AT, Bin-Hasan S, Narang I. Diagnosis, management and pathophysiology of central sleep apnea in children. Paediatr Respir Rev. 2019 Apr;30:49-57. doi: 10.1016/j.prrv.2018.07.005. Epub 2018 Jul 25.

    PubMed 30170958

  • Marcus CL, Brooks LJ, Draper KA, Gozal D, Halbower AC, Jones J, Schechter MS, Sheldon SH, Spruyt K, Ward SD, Lehmann C, Shiffman RN; American Academy of Pediatrics. Diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics. 2012 Sep;130(3):576-84. doi: 10.1542/peds.2012-1671. Epub 2012 Aug 27.

    PubMed 22926173

  • Ramirez A, Khirani S, Aloui S, Delord V, Borel JC, Pepin JL, Fauroux B. Continuous positive airway pressure and noninvasive ventilation adherence in children. Sleep Med. 2013 Dec;14(12):1290-4. doi: 10.1016/j.sleep.2013.06.020. Epub 2013 Sep 25.

    PubMed 24157098

  • Bhattacharjee R, Benjafield AV, Armitstead J, Cistulli PA, Nunez CM, Pepin JD, Woehrle H, Yan Y, Malhotra A; medXcloud group. Adherence in children using positive airway pressure therapy: a big-data analysis. Lancet Digit Health. 2020 Feb;2(2):e94-e101. doi: 10.1016/S2589-7500(19)30214-6. Epub 2019 Dec 23.

    PubMed 33334566

  • 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.

    PubMed 27423917

  • Fauroux B, Abel F, Amaddeo A, Bignamini E, Chan E, Corel L, Cutrera R, Ersu R, Installe S, Khirani S, Krivec U, Narayan O, MacLean J, Perez De Sa V, Pons-Odena M, Stehling F, Ferreira RT, Verhulst S. ERS statement on paediatric long-term noninvasive respiratory support. Eur Respir J. 2022 Jun 2;59(6):2101404. doi: 10.1183/13993003.01404-2021. Print 2022 Jun.

    PubMed 34916265

Questions about this trial

What is this clinical trial studying?

An observational study of Sleep Apnea Syndromes in Children and Obesity in Children, run by University Hospital, Grenoble at 2 sites 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 2 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: opening soon, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Julie CASSIBBA, MD (+33476765566, jcassibba@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

describe the perceived success of the use of the respiratory support from the parent's point of view (time frame: Assessment during the filling of the questionnaire at enrollment). 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 NCT06692660, which also lists 9 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 Nov 2024.

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