Sleep Respiratory Disorders Evaluation in Sickle Cell Disease Children

Completed

• Conditions: Sickle Cell Disease; Respiration Disorders

• Registration Number: NCT01565954
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2012-03-27
• Study First Submitted QC: 2012-03-27
• Study First Posted: 2012-03-29
• Study Start: 2014-01
• Status Verified: 2018-02
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Last Update Submitted: 2019-03-12
• Last Update Posted: 2019-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vaso-occlusive and cerebral complications frequency	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

Name	Time	Method
Relationship between sleep abnormalities and transcranial doppler abnormalities	2 months	Analyze the relationship between sleep respiratory and non-respiratory abnormalities and transcranial doppler abnormalities
Polysomnography relevance compared to sleep ventilatory polygraphy	2 months	Polysomnography relevance compared to sleep ventilatory polygraphy in diagnosis of sleep abnormalities
Respiratory sleep abnormalities frequency	18 months	Respiratory sleep abnormalities frequency in a population of young sickle cell disease children.

Trial Locations

Locations (1)

Assistance Publique - Hôpitaux de Paris; 🇫🇷 Paris, France