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Completed

NCT Number: NCT01565954

Sleep Respiratory Disorders Evaluation in Sickle Cell Disease Children

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.

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Key information

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Systematic Evaluation of Sleep Respiratory Disorders During Sleep in Children With Sickle Cell Disease

Acronym: SOMMEDREP

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Mar 29, 2012
Registry last updated
Mar 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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