Sickle Cell DiseaseSOMMEDREPNCT01565954
Sleep Respiratory Disorders Evaluation in Sickle Cell Disease Children
An observational study of Sickle Cell Disease and Respiration Disorders, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
In Sickle cell disease children, sleep respiratory abnormalities are risk factors for vaso-occlusive complications, as well as cerebral vasculopathy. A 18 months follow-up children with sickle cell disease evaluating sleep respiratory problems frequency and etiology, as well as their influence on sickle cell disease… Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Sickle Cell Disease, Respiration Disorders
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Aug 2018
- 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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: The objective of this study is to provide an early curative treatment for homozygous sickle cell children in age group of 2 to 6 years based on the anomalies identified in polysomnography. The choice of the age of 2 to 6 is linked to the peak risk of onset of cerebrovascular occlusive complications in this age
Who may be able to join
- Sickle cell disease children with either sickle cell anemia, compound heterozygozity SB0-thalassemia, or SDPunjab,
- no prior transfusion program within 3 months,
- no prior treatment with hydroxycarbamide within 3 months,
- Aged 2 to 6 years,
- Parents or tutors signed informed consent,
- Prior physical examination,
- Social security insurance.
Who cannot join
- Encephalopathy
- Other disease that could interfere with protocol exams realization
- Nitrous oxide analgesia contre-indication
- Conventional hospitalization in the past 3 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Systematic Evaluation of Sleep Respiratory Disorders During Sleep in Children With Sickle Cell Disease
In Sickle cell disease children, sleep respiratory abnormalities are risk factors for vaso-occlusive complications, as well as cerebral vasculopathy.
A 18 months follow-up children with sickle cell disease evaluating sleep respiratory problems frequency and etiology, as well as their influence on sickle cell disease complications.
Read the detailed description
- Inclusion visit with physical examination. A 2.9 ml blood sample will be necessary, if not done within the framework of care within 6 months for: CBC (Cell Blood Count), reticulocytes counts (1.2 ml of blood), liver enzymes, electrolytes, urea, creatininemia (1,2 ml of blood) and fetal hemoglobin (0.5 ml of blood). - A complete standardized examination including nasopharynx endoscopy, if not yet done in usual care, to identified upper airway obstruction
- A standardized pneumology evaluation to identified obstructive lung symptomatology
- An ambulatory polysomnography will be performed within days following inclusion, during sleep and will allow electroencephalogram recording, oculomotricity, muscles (mentalis muscles and tibialis anterior) movements, electrocardiogram and respiratory activity recording.
The steering committee will classify the children in three populations based on their exam results:
- Group 1: no abnormality in polysomnography
- Group 2: obstructive sleep-related disorder
- Group 3: isolated sleep hypoxemia for group3, patients will have a new ambulatory polysomnography.
- Conditions
- Sickle Cell Disease, Respiration Disorders
- Keywords
- Sickle Cell Disease, Respiration Disorders, Polysomnography
- Medical subject headings
- Anemia, Sickle Cell, Respiration Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaso-occlusive and cerebral complications frequency
Vaso-occlusive complications frequency and abnormal transcranial doppler (TCD) during the 18 months of follow up (cohort study) 3 subpopulations will be identified upon polysomnographic results:
- Group 1: normal polysomnography
- Group 2: sleep abnormalities related to obstructive upper airway disease or bronchial disease
- Group 3: sleep abnormalities associated with non-obstructive pattern and isolated hypoxemia identified. The therapeutic trial will be done on this group.
Measured: 18 months
Secondary outcomes (3)
Respiratory sleep abnormalities frequency
Respiratory sleep abnormalities frequency in a population of young sickle cell disease children.
Measured: 18 months
Relationship between sleep abnormalities and transcranial doppler abnormalities
Analyze the relationship between sleep respiratory and non-respiratory abnormalities and transcranial doppler abnormalities
Measured: 2 months
Polysomnography relevance compared to sleep ventilatory polygraphy
Polysomnography relevance compared to sleep ventilatory polygraphy in diagnosis of sleep abnormalities
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study startJan 2014
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malika BENKERROU, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01565954
- Sponsor's protocol ID
- P110102
- Other IDs
- 2011-005029-31
- Acronym
- SOMMEDREP
- Status last verified
- Feb 2018
- First submitted
- 27 Mar 2012
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Evaluation of Sleep Respiratory Disorders During Sleep in Children With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT01565954
- Acronym / sponsor ID
- SOMMEDREP / P110102
- Conditions
- Sickle Cell Disease, Respiration Disorders
- Keywords
- Sickle Cell Disease, Respiration Disorders, Polysomnography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 29 Mar 2012 (estimated)
- 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.
In Sickle cell disease children, sleep respiratory abnormalities are risk factors for vaso-occlusive complications, as well as cerebral vasculopathy.
A 18 months follow-up children with sickle cell disease evaluating sleep respiratory problems frequency and etiology, as well as their influence on sickle cell disease complications.
Detailed description
- Inclusion visit with physical examination. A 2.9 ml blood sample will be necessary, if not done within the framework of care within 6 months for: CBC (Cell Blood Count), reticulocytes counts (1.2 ml of blood), liver enzymes, electrolytes, urea, creatininemia (1,2 ml of blood) and fetal hemoglobin (0.5 ml of blood). - A complete standardized examination including nasopharynx endoscopy, if not yet done in usual care, to identified upper airway obstruction
- A standardized pneumology evaluation to identified obstructive lung symptomatology
- An ambulatory polysomnography will be performed within days following inclusion, during sleep and will allow electroencephalogram recording, oculomotricity, muscles (mentalis muscles and tibialis anterior) movements, electrocardiogram and respiratory activity recording.
The steering committee will classify the children in three populations based on their exam results:
- Group 1: no abnormality in polysomnography
- Group 2: obstructive sleep-related disorder
- Group 3: isolated sleep hypoxemia for group3, patients will have a new ambulatory polysomnography.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The objective of this study is to provide an early curative treatment for homozygous sickle cell children in age group of 2 to 6 years based on the anomalies identified in polysomnography. The choice of the age of 2 to 6 is linked to the peak risk of onset of cerebrovascular occlusive complications in this age
Key inclusion criteria (7 listed)
- Sickle cell disease children with either sickle cell anemia, compound heterozygozity SB0-thalassemia, or SDPunjab,
- no prior transfusion program within 3 months,
- no prior treatment with hydroxycarbamide within 3 months,
- Aged 2 to 6 years,
- Parents or tutors signed informed consent,
Key exclusion criteria (4 listed)
- Encephalopathy
- Other disease that could interfere with protocol exams realization
- Nitrous oxide analgesia contre-indication
- Conventional hospitalization in the past 3 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Vaso-occlusive and cerebral complications frequency
Time frame: 18 months
Vaso-occlusive complications frequency and abnormal transcranial doppler (TCD) during the 18 months of follow up (cohort study) 3 subpopulations will be identified upon polysomnographic results: * Group 1: normal polysomnography * Group 2: sleep abnormalities related to obstructive upper airway disease or bronchial disease * Group 3: sleep abnormalities associated with non-obstructive pattern and isolated hypoxemia identified. The therapeutic trial will be done on this group.
3 secondary outcomes
Respiratory sleep abnormalities frequency
Time frame: 18 months
Relationship between sleep abnormalities and transcranial doppler abnormalities
Time frame: 2 months
Polysomnography relevance compared to sleep ventilatory polygraphy
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
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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.
Malika BENKERROU, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Sickle Cell Disease and Respiration Disorders, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 7 inclusion and 4 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: finished, as of the sponsor's last update on 13 Mar 2019. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaso-occlusive and cerebral complications frequency (time frame: 18 months). 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 13 Mar 2019.