Sleep Respiratory Disorders Evaluation in Sickle Cell Disease Children

Sickle Cell Disease Clinical Trial

— SOMMEDREP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01565954
• Other study ID #: P110102
• Secondary ID: 2011-005029-31
• Status: Completed
• Start date: January 2014
• Est. completion date: August 2018

Study information

• Verified date: February 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Disease
• Respiration Disorders
• Respiratory Tract Diseases
• Sickle Cell Disease

Locations

Country	Name	City	State
France	Assistance Publique - Hôpitaux de Paris	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaso-occlusive and cerebral complications frequency	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.	18 months
Secondary	Respiratory sleep abnormalities frequency	Respiratory sleep abnormalities frequency in a population of young sickle cell disease children.	18 months
Secondary	Relationship between sleep abnormalities and transcranial doppler abnormalities	Analyze the relationship between sleep respiratory and non-respiratory abnormalities and transcranial doppler abnormalities	2 months
Secondary	Polysomnography relevance compared to sleep ventilatory polygraphy	Polysomnography relevance compared to sleep ventilatory polygraphy in diagnosis of sleep abnormalities	2 months