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Sleep Respiratory Disorders Evaluation in Sickle Cell Disease Children (SOMMEDREP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01565954
Recruitment Status : Completed
First Posted : March 29, 2012
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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 complications.


Condition or disease
Sickle Cell Disease Respiration Disorders

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.

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Study Type : Observational
Actual Enrollment : 62 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Respiratory sleep abnormalities frequency [ Time Frame: 18 months ]
    Respiratory sleep abnormalities frequency in a population of young sickle cell disease children.

  2. 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

  3. Polysomnography relevance compared to sleep ventilatory polygraphy [ Time Frame: 2 months ]
    Polysomnography relevance compared to sleep ventilatory polygraphy in diagnosis of sleep abnormalities



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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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
Criteria

Inclusion Criteria:

  • 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.

Exclusion criteria:

  • Encephalopathy
  • Other disease that could interfere with protocol exams realization
  • Nitrous oxide analgesia contre-indication
  • Conventional hospitalization in the past 3 weeks

Information from the National Library of Medicine

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


Locations
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France
Assistance Publique - Hôpitaux de Paris
Paris, France, 75019
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Malika BENKERROU, MD, PhD Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01565954    
Other Study ID Numbers: P110102
2011-005029-31 ( EudraCT Number )
First Posted: March 29, 2012    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: February 2018
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Sickle Cell Disease
Respiration Disorders
Polysomnography
Additional relevant MeSH terms:
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Respiration Disorders
Respiratory Tract Diseases
Anemia, Sickle Cell
Disease
Pathologic Processes
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn