NCT06337149

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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
4mo left

Started Feb 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress87%
Feb 2024Sep 2026

Study Start

First participant enrolled

February 29, 2024

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 29, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

March 29, 2024

Status Verified

March 1, 2024

Enrollment Period

1 year

First QC Date

March 22, 2024

Last Update Submit

March 22, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Wechsler scale

    Neuropsychological assessement

    12 months

  • Nepsy II test

    Neuropsychological assessement

    12 months

Interventions

neuropsychological tests used usually in clinical practice (TEA-ch, NEPSY, BRIEF) and research (Conners 3, K-CPT II or CPT III, Flankers Task)

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Ondine Syndrome, children with CCHS

You may qualify if:

  • children with CCHS (Ondine Syndrome) and IQ \> 70, age from 6 to 16 years old, french speaking, informed consent signed by both parents and oral agreement in principle given by the subject.

You may not qualify if:

  • IQ \< 70

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert Debre Hospital

Paris, 75019, France

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, CentralCongenital central hypoventilation syndrome

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • Anne-Claude TABET, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christophe DELCLAUX, MD, PhD

CONTACT

Benjamin DUDOIGNON, MD

CONTACT

Study Design

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

Study Record Dates

First Submitted

March 22, 2024

First Posted

March 29, 2024

Study Start

February 29, 2024

Primary Completion

March 1, 2025

Study Completion (Estimated)

September 1, 2026

Last Updated

March 29, 2024

Record last verified: 2024-03

Locations