Sickle Cell Disease Clinical Trial
Official title:
Systematic Evaluation of Sleep Respiratory Disorders During Sleep in Children With Sickle Cell Disease
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.
- 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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02227472 -
Working Memory and School Readiness in Preschool-Aged Children With Sickle Cell Disease
|
||
| Recruiting |
NCT06301893 -
Uganda Sickle Surveillance Study (US-3)
|
||
| Recruiting |
NCT04398628 -
ATHN Transcends: A Natural History Study of Non-Neoplastic Hematologic Disorders
|
||
| Completed |
NCT02522104 -
Evaluation of the Impact of Renal Function on the Pharmacokinetics of SIKLOS ® (DARH)
|
Phase 4 | |
| Recruiting |
NCT04688411 -
An mHealth Strategy to Improve Medication Adherence in Adolescents With Sickle Cell Disease
|
N/A | |
| Terminated |
NCT03615924 -
Effect of Ticagrelor vs. Placebo in the Reduction of Vaso-occlusive Crises in Pediatric Patients With Sickle Cell Disease
|
Phase 3 | |
| Not yet recruiting |
NCT06300723 -
Clinical Study of BRL-101 in Severe SCD
|
N/A | |
| Recruiting |
NCT03937817 -
Collection of Human Biospecimens for Basic and Clinical Research Into Globin Variants
|
||
| Completed |
NCT04134299 -
To Assess Safety, Tolerability and Physiological Effects on Structure and Function of AXA4010 in Subjects With Sickle Cell Disease
|
N/A | |
| Completed |
NCT04917783 -
Health Literacy - Neurocognitive Screening in Pediatric SCD
|
N/A | |
| Completed |
NCT02580565 -
Prevalence of Problematic Use of Equimolar Mixture of Oxygen and Nitrous Oxide and Analgesics in the Sickle-cell Disease
|
||
| Recruiting |
NCT04754711 -
Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition
|
N/A | |
| Completed |
NCT04388241 -
Preliminary Feasibility and Efficacy of Behavioral Intervention to Reduce Pain-Related Disability in Pediatric SCD
|
N/A | |
| Recruiting |
NCT05431088 -
A Phase 2/3 Study in Adult and Pediatric Participants With SCD
|
Phase 2/Phase 3 | |
| Completed |
NCT01158794 -
Genes Influencing Iron Overload State
|
||
| Recruiting |
NCT03027258 -
Point-of-Delivery Prenatal Test Results Through mHealth to Improve Birth Outcome
|
N/A | |
| Withdrawn |
NCT02960503 -
Macrolide Therapy to Improve Forced Expiratory Volume in 1 Second in Adults With Sickle Cell Disease
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT02630394 -
A Pilot Study of Azithromycin Prophylaxis for Acute Chest Syndrome in Sickle Cell Disease
|
Phase 1 | |
| Completed |
NCT02565082 -
Evaluation of the Hemostatic Potential in Sickle Cell Disease Patients
|
N/A | |
| Completed |
NCT02567682 -
Drug Interaction Study of GBT440 With Caffeine, S-warfarin, Omeprazole, and Midazolam in Healthy Subjects
|
Phase 1 |