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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01565954
Other study ID # P110102
Secondary ID 2011-005029-31
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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