RecruitingNot Applicable

CCHS Secure Health-hub Advancing Research Efforts (CCHS SHARE)

United States125 participantsStarted 2024-09-01

Plain-language summary

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

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Participants with a confirmed CCHS diagnosis (confirmed alveolar hypoventilation and PHOX2B mutation testing results), of all ages and genders, who are followed clinically. Exclusion Criteria: An unconfirmed diagnosis of CCHS or unconfirmed PHOX2B mutation or not followed clinically

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Patient Quality of Life

Timeframe: Up to every 14 months

Caregiver Burden

Timeframe: Up to every 14 months

Patient and Caregiver Sleep

Timeframe: Up to every 14 months

Autonomic Symptom Profile

Timeframe: Up to every 14 months

Characterize CCHS from a clinical perspective using standardized common data elements (CDEs) in the clinical setting.

Timeframe: Up to every 14 months

Trial details

NCT IDNCT06554275

SponsorAnn & Robert H Lurie Children's Hospital of Chicago

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-06-01

Contact for this trial

Casey Rand, MSDS

312-227-3300 Crand@luriechildrens.org

View on ClinicalTrials.gov More Congenital Central Hypoventilation Syndrome trials

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Patient Quality of Life

Timeframe: Up to every 14 months

Caregiver Burden

Timeframe: Up to every 14 months

Patient and Caregiver Sleep

Timeframe: Up to every 14 months

Autonomic Symptom Profile

Timeframe: Up to every 14 months

Characterize CCHS from a clinical perspective using standardized common data elements (CDEs) in the clinical setting.

Timeframe: Up to every 14 months