Sleep Respiratory Disorders Evaluation in Sickle Cell Disease Children (SOMMEDREP)
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|ClinicalTrials.gov Identifier: NCT01565954|
Recruitment Status : Completed
First Posted : March 29, 2012
Last Update Posted : March 13, 2019
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.
|Condition or disease|
|Sickle Cell Disease Respiration Disorders|
- 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 Type :||Observational|
|Actual Enrollment :||62 participants|
|Official Title:||Systematic Evaluation of Sleep Respiratory Disorders During Sleep in Children With Sickle Cell Disease|
|Actual Study Start Date :||January 2014|
|Actual Primary Completion Date :||August 2018|
|Actual Study Completion Date :||August 2018|
- 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.
- Respiratory sleep abnormalities frequency [ Time Frame: 18 months ]Respiratory sleep abnormalities frequency in a population of young sickle cell disease children.
- Relationship between sleep abnormalities and transcranial doppler abnormalities [ Time Frame: 2 months ]Analyze the relationship between sleep respiratory and non-respiratory abnormalities and transcranial doppler abnormalities
- Polysomnography relevance compared to sleep ventilatory polygraphy [ Time Frame: 2 months ]Polysomnography relevance compared to sleep ventilatory polygraphy in diagnosis of sleep abnormalities
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01565954
|Assistance Publique - Hôpitaux de Paris|
|Paris, France, 75019|
|Principal Investigator:||Malika BENKERROU, MD, PhD||Assistance Publique - Hôpitaux de Paris|