Malformation BrainCHDSBNCT05913297
Neuroradiology Assesses Chiari Malformation's Impact on Airways, Cranial Base, and Sleep Disorders in Children.
An observational study of Malformation Brain, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The severity of sleep disorders in patients with Chiari malformations can vary. The investigators propose to establish a correlation between the severity of sleep-disordered breathing (SDB) and the quantitative neuroradiological data of the airways, cranial base foramina, and posterior cranial fossae Read more about this study
- Who is it for?
- Ages 3 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Malformation Brain
- What is being tested?
- Magnetic Resonance and Polysomnographic evaluation
- How many people
- 138 participants
- Where
- 1 siteItaly
- Study dates
- 8 Jun 2023to 8 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children (males or females) aged between 3 years and 18 years. Clinical diagnosis of Chiari malformation 1 and 2.
Who may be able to join
- Children (males or females) aged between 3 years and 18 years.
- Clinical diagnosis of Chiari malformation 1 and 2.
- Presence of informed consent for the initial clinical evaluation. The investigators commit to providing appropriate informational sheets to the parents of the patients (for those included in the study) during the initial clinical evaluation.
Who cannot join
- Chiari Malformation I and II associated with neurological diseases or craniofacial malformations.
- Cranial trauma or cardiac arrest.
- Administration of centrally acting medications within 2 weeks prior to the study, except for antiepileptic treatment for patients who have had seizures.
- Associated brain and cranial base tumors.
- Refusal to sign the informed consent for the initial clinical evaluation. The investigators commit to providing appropriate informational sheets to the parents of the patients (for those included in the study) during the initial clinical evaluation.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Gemelli IRCCS
Rome, Italy, 00168
Marina Cicerone, MD, 3484745545 ext. +39, marina.cicerone@policlinicogemelli.it
About this study
Official title: Quantitative Neuroradiological Assessment of the Airways, Cranial Base Foramina, and Posterior Cranial Fossae in Children with Chiari Malformation: Relationship with Sleep Disorders
The severity of sleep disorders in patients with Chiari malformations can vary. The investigators propose to establish a correlation between the severity of sleep-disordered breathing (SDB) and the quantitative neuroradiological data of the airways, cranial base foramina, and posterior cranial fossae
Read the detailed description
Primary objective of the study is the evaluation of sleep-disordered breathing (SDB) in two distinct pediatric populations of patients with Chiari Malformation Type 1 (CM-I) and Chiari Malformation Type 2 (CM-II).
Secondary objectives:
Stratify the presence of SDB into central and obstructive origins in the two study populations.
Assess the volume of posterior cranial fossae, airway volume, and area of cranial base foramina in both groups.
Determine the relationships between SDB and morphological-quantitative anomalies associated with CM.
- Conditions
- Malformation Brain
- Being tested
- Magnetic Resonance, Polysomnographic evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic ResonanceDiagnostic test
Magnetic Resonance
Polysomnographic evaluationDiagnostic test
Polysomnographic evaluation
| Study group | Role | What they receive |
|---|---|---|
| Malformation Chiari 1 | Magnetic Resonance Receives: Diagnostic Test: Magnetic Resonance; Diagnostic Test: Polysomnographic evaluation | |
| Malformation Chiari 2 | Magnetic Resonance Receives: Diagnostic Test: Magnetic Resonance; Diagnostic Test: Polysomnographic evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of SDB
The primary endpoint of the study is the prevalence of sleep-disordered breathing (SDB) in two distinct pediatric populations of patients with CM-I and CM-II.
Measured: 3 years
Secondary outcomes (3)
volume of posterior cranial fossae
Evaluation of the volume of posterior cranial fossae CM-1 and CM-2, respectively, compared to an age-matched control group.
Measured: 3 years
airway volume
Evaluation of the airway volume, in CM-1 and CM-2, respectively, compared to an age-matched control group
Measured: 3 years
area of cranial base foramina
Evaluation of the area of cranial base foramina in CM-1 and CM-2, respectively, compared to an age-matched control group
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start8 Jun 2023
- Primary completion8 Jun 2025 (estimated)
- Study completion8 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malformation BrainStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Calandrelli Rosalinda, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Rosalinda Calandrelli, MD, Principal investigator, Fondazione Policlinico A. Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05913297
- Sponsor's protocol ID
- 5791 NO PROFIT
- Acronym
- CHDSB
- Status last verified
- Jun 2024
- First submitted
- 8 Jun 2023
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Neuroradiological Assessment of the Airways, Cranial Base Foramina, and Posterior Cranial Fossae in Children with Chiari Malformation: Relationship with Sleep Disorders
- ClinicalTrials.gov ID
- NCT05913297
- Acronym / sponsor ID
- CHDSB / 5791 NO PROFIT
- Conditions
- Malformation Brain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- 8 Jun 2025 (estimated)
- Study completion
- 8 Jun 2026 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The severity of sleep disorders in patients with Chiari malformations can vary. The investigators propose to establish a correlation between the severity of sleep-disordered breathing (SDB) and the quantitative neuroradiological data of the airways, cranial base foramina, and posterior cranial fossae
Detailed description
Primary objective of the study is the evaluation of sleep-disordered breathing (SDB) in two distinct pediatric populations of patients with Chiari Malformation Type 1 (CM-I) and Chiari Malformation Type 2 (CM-II).
Secondary objectives:
Stratify the presence of SDB into central and obstructive origins in the two study populations.
Assess the volume of posterior cranial fossae, airway volume, and area of cranial base foramina in both groups.
Determine the relationships between SDB and morphological-quantitative anomalies associated with CM.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Malformation Chiari 1 | – | Diagnostic Test: Magnetic Resonance, Diagnostic Test: Polysomnographic evaluationMagnetic Resonance |
| Malformation Chiari 2 | – | Diagnostic Test: Magnetic Resonance, Diagnostic Test: Polysomnographic evaluationMagnetic Resonance |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children (males or females) aged between 3 years and 18 years. Clinical diagnosis of Chiari malformation 1 and 2.
Key inclusion criteria (3 listed)
- Children (males or females) aged between 3 years and 18 years.
- Clinical diagnosis of Chiari malformation 1 and 2.
- Presence of informed consent for the initial clinical evaluation. The investigators commit to providing appropriate informational sheets to the parents of the patients (for those included in the study) during the initial clinical evaluation.
Key exclusion criteria (5 listed)
- Chiari Malformation I and II associated with neurological diseases or craniofacial malformations.
- Cranial trauma or cardiac arrest.
- Administration of centrally acting medications within 2 weeks prior to the study, except for antiepileptic treatment for patients who have had seizures.
- Associated brain and cranial base tumors.
- Refusal to sign the informed consent for the initial clinical evaluation. The investigators commit to providing appropriate informational sheets to the parents of the patients (for those included in the study) during the initial clinical evaluation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic ResonanceMagnetic Resonance | Diagnostic test | Malformation Chiari 1, Malformation Chiari 2 |
| Polysomnographic evaluationPolysomnographic evaluation | Diagnostic test | Malformation Chiari 1, Malformation Chiari 2 |
Primary outcome
prevalence of SDB
Time frame: 3 years
The primary endpoint of the study is the prevalence of sleep-disordered breathing (SDB) in two distinct pediatric populations of patients with CM-I and CM-II.
3 secondary outcomes
volume of posterior cranial fossae
Time frame: 3 years
airway volume
Time frame: 3 years
area of cranial base foramina
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosalinda Calandrelli, MD principal investigator
Fondazione Policlinico A. Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malformation Brain, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rosalinda Calandrelli, MD (3385417971 ext. +39, rosalinda.calandrelli@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of SDB (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.