Sleep Respiratory Disorders Evaluation in Sickle Cell Disease Children

NCT01565954 | Completed

• 2 other identifiers: P1101022011-005029-31
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease; Respiration Disorders

Keywords

Sickle Cell Disease; Respiration Disorders; Polysomnography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Respiratory sleep abnormalities frequency

  18 months

• Relationship between sleep abnormalities and transcranial doppler abnormalities

  2 months

• Polysomnography relevance compared to sleep ventilatory polygraphy

  2 months

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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.

You may not qualify if:

• Encephalopathy
• Other disease that could interfere with protocol exams realization
• Nitrous oxide analgesia contre-indication
• Conventional hospitalization in the past 3 weeks

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Assistance Publique - Hôpitaux de Paris

Paris, 75019, France

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Respiration Disorders

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Respiratory Tract Diseases

Study Officials

• Malika BENKERROU, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2012
• First Posted: March 29, 2012
• Study Start: January 1, 2014
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: March 13, 2019

Record last verified: 2018-02

Locations

FR (1)