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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

Tracking Information
First Submitted Date March 27, 2012
First Posted Date March 29, 2012
Last Update Posted Date March 13, 2019
Actual Study Start Date January 2014
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 27, 2012)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 28, 2016)
  • 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
Original Secondary Outcome Measures
 (submitted: March 27, 2012)
  • Hydroxycarbamide versus placebo efficacy [ Time Frame: 16 months ]
    Hydroxycarbamide versus placebo efficacy in a group of young sickle cell disease patients whose polysomnographic results showed an isolated hypoxemia associated with a non-obstructive airway pattern. Efficacy will be assessed on:
    • Vaso-occlusive crisis occurrence and / or an abnormal TCD occurrence during the next 16 months
    • Reduction / disappearance at 16 months of the nocturnal hypoxemia observed during the initial polysomnography
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Sleep Respiratory Disorders Evaluation in Sickle Cell Disease Children
Official Title Systematic Evaluation of Sleep Respiratory Disorders During Sleep in Children With Sickle Cell Disease
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.

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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Sickle Cell Disease
  • Respiration Disorders
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 1, 2018)
62
Original Estimated Enrollment
 (submitted: March 27, 2012)
280
Actual Study Completion Date August 2018
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years to 6 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT01565954
Other Study ID Numbers P110102
2011-005029-31 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators Not Provided
Investigators
Principal Investigator: Malika BENKERROU, MD, PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date February 2018