NCT06554275|Recruiting
CCHS Secure Health-hub Advancing Research Efforts (CCHS SHARE)
CCHS SHARE: A Multi-center Longitudinal Natural History Study
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CCHS SHARE: A Multi-center Longitudinal Natural History Study
Sponsor study identifier
Secondary identifiers
observational
125
1 country
1
Study Start
September 1, 2024
Actual (reported)Primary Completion
June 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The purpose of this study is to capture longitudinal natural history data in Congenital Central Hypoventilation Syndrome (CCHS). This will include capturing standardized clinical data from standard of care assessments at several CCHS referral centers. Funding source-FDA OOPD
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 9, 2024
Actual (reported)August 15, 2024
Actual (reported)September 1, 2024
Actual (reported)June 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Patient Quality of Life
Patient reported outcome common data elements reflecting core aspects of CCHS will be captured using the Pediatric Quality of Life Inventory (PedsQL) and the 36-item Short Form Health Survey (SF-36)
Up to every 14 months
Caregiver Burden
Caregiver burden will be assessed using the Zarit Burden Interview
Up to every 14 months
Patient and Caregiver Sleep
Patient and caregiver sleep will be assessed using PROMIS Sleep Disturbance and Sleep-Related Impairment short forms
Up to every 14 months
Autonomic Symptom Profile
Validated measures of autonomic function will be captured including data elements from COMPASS-31 and a patient-reported clinical and disease-specific outcomes symptomatology questionnaire relating to CCHS.
Up to every 14 months
Characterize CCHS from a clinical perspective using standardized common data elements (CDEs) in the clinical setting.
CDEs will include key data points from standard of care assessments of respiratory and cardiovascular function, sleep, exercise capacity, neurocognition, and blood labs.
Any individual with a confirmed CCHS diagnosis treated clinically at any of the participating sites.
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Debra E Weese-Mayer, MD
Ann & Robert H Lurie Children's Hospital of Chicago
Maxime Patout, MD
Groupe Hospitalier Pitie-Salpetriere
Martin Samuels, MD
Great Ormond Street Hospital-London (GOSH)
Christophe Delclaux, MD
Hopital Universitaire Robert-Debre
First Submitted
August 9, 2024
First Posted
August 15, 2024
Study Start
September 1, 2024
Actual (reported)Primary Completion
June 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Neurocognition in Congenital Central Hypoventilation Syndrome (CCHS)
Up to every 14 months
Contact the study team to confirm eligibility.
Study Completion
August 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 16, 2025
Record last verified: 2025-07
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Source: ClinicalTrials.gov.
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