An observational study in Ondine Syndrome and Congenital Central Hypoventilation Syndrome (CCHS), sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 6 Years to 16 Years. Per ClinicalTrials.gov, last updated 2024-03-29.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
Among 14 studies in Sleep Apnea, Central with a site in France — 3 open to participants now, 3 under way, none of them phase 3. Sleep Apnea, Central · France.
Among the 14 studies in Sleep Apnea, Central with a site in France, this one is the only one that started in 2024, is one of 8 observational ones, and was the 13th registered.
96 studies on the registry are indexed under Sleep Apnea, Central; 18 are open to participants now.
This study's planned enrollment of 20 is below the median of 148 across 36 observational studies indexed under Sleep Apnea, Central.
Browse Sleep Apnea, Central studies →3 of the 14 studies in Sleep Apnea, Central with a site in France are open now.
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 13 Sleep Apnea, Central studies recruiting now, 8 (62%) set no upper age limit and 3 (23%) stop at 75 or younger; 4 take children under 18; 5 take healthy volunteers.
This study: 6 Years to 16 Years · all sexes · no healthy volunteers.
The full table on the hub →14 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 1 started in 2024.
Median enrollment 104 across the 6 interventional studies, 287 across the 8 observational. Of the 9 that completed or were terminated, 0 (0%) have results posted.
3 of 14 have an industry lead sponsor. The 8 most frequent:
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
Assistance Publique - Hôpitaux de Paris has 4 studies filed under Sleep Apnea, Central — fewer than ten, so there is no comparison to draw.
1 of the studies in Sleep Apnea, Central with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07081464Assistance Publique - Hôpitaux de ParisLocus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome) | 2027-11-15 |
Among the 14 studies in Sleep Apnea, Central with a site in France, from their registry updates:
Congenital central hypoventilation syndrome (CCHS) is a rare disorder of autonomic and respiratory regulation that alters oxygen delivery to the brain. CCHS patients are at risk for broad neurocognitive deficits. Patients retain ventilatory activity when awake through a respiratory-related cortical network but the need to mobilise cortical resources to breathe lead to breathing-cognition interferences during cognitive tasks. The purpose of this study is to assess the relationship between breathing pattern and attention in CCHS children
Congenital central hypoventilation syndrome (CCHS) is a rare genetic disorder caused by PHOX2B gene mutations. CCHS is characterized by hypoventilation and autonomic nervous system dysregulation and global dysautonomia necessitating artificial ventilation. CCHS increases the risk to develop neurocognitive deficiencies. Patients retain ventilatory activity when awake through a respiratory-related cortical network but the need to mobilise cortical resources to breathe lead to breathing-cognition interferences during cognitive tasks.
No study has focused on attentional abilities in CCHS pediatric population to highlight a specific attentional profile or to investigate the double task paradigm impact when attentional resources and management of spontaneous breathing are competing.
The aim of this study is to (i) Understand the link between spontaneous breathing and attentional functioning in CCHS children by comparing the evolution of breathing pattern relatively to the complexity of the attentionals tasks.
(ii) Characterize the attentional profil of CCHS patients by comparing attentional tasks performance of CCHS children versus control children (iii) Measure the impact of variables such as age and CO2 ventilatory response on attentional performances, by comparing attentional performances of the young patient group (\< 50e p) to the attentional performances of older patient group (> 50e p) and studying the correlation between ventilatory response to CO2 and attentional performance (iv) Investigate the link between clinicals and behavioural tools regarding attentional and executive domains by studying the correlation between the cognitif test and inventories results Hypothese : attentional task could be link to a deficit in breathing function leading to hypoxemia and hypercapnia (alveolar hypoventilation).
Methode : compare CCHS patients performances and control group in neuropsychological tests used usually in clinical practice (TEA-ch, NEPSY, BRIEF) and research (Conners 3, K-CPT II or CPT III, Flankers Task).
Twenty children (age range : 6 to 16 years old) with CCHS and IQ > 70 and twenty control subjects in the same age range without neurodevelopmental disorder diagnosis will be enrolled.
Firstly, subjects of both groups will respond to a neuropsychological assessment including intellectual Wechsler scale (WISC V), instruction comprehension test (Nepsy II), a manual laterality test and attentional and executive assessment (TEA-ch + NEPSY II).
Secondarily, CCHS group assessment will be completed with a double task paradigm. Our protocol includes a simple task condition (the patient must remain still) and a double task condition (the patient respond to the flanker tasks and K-CPT II or CPT III).
Procedure : continuous recording of breathing parameters : oxygen saturation, exhaled PCO2 (PETCO2 with nasal cannula) and respiratory rate. Breathing respiratory parameters will be recorded during simple condition and double task condition. "
Ondine Syndrome, children with CCHS
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
neuropsychological tests used usually in clinical practice (TEA-ch, NEPSY, BRIEF) and research (Conners 3, K-CPT II or CPT III, Flankers Task)
Wechsler scale
Neuropsychological assessement
Time frame: 12 months
Nepsy II test
Neuropsychological assessement
Time frame: 12 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started Feb 2024 (actual). Primary completion is estimated for Mar 2025, 12 months after the start.
Of 18 observational studies under Sleep Apnea, Central, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 107. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
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