Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06337149
Status:
RECRUITING
Last Update Posted:
2024-03-29
First Post:
2024-03-22
Brief Title:
Relationship Between Breathing and Attention in Children With Ondine Syndrome
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Relationship Between Breathing and Attention in Children With Ondine Syndrome
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OndineCo
Brief Summary:
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IDRCB 2023-A00006-39 | REGISTRY | IDRCB ANSM | None |