Sleep Study in Adult Patients With Major Sickle Cell Disease With Paroxysmal Nocturnal Events
NCT ID: NCT02539771
Last Updated: 2023-05-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
114 participants
INTERVENTIONAL
2014-09-17
2019-04-10
Brief Summary
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The confirmation of this hypothesis will lead investigator to propose a systematic screening of obstructive sleep apnea (OSA) in patients with nocturnal VOC. Moreover, systematic treatment of OSA in sickle cell patients could help significantly reduce the number and severity of nocturnal VOC.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Nocturnal VOC
Polysomnography and blood sample
Blood collection is a specific intervention of protocol for the 3 arms. Polysomnography is a specific intervention for the arms " Diurnal VOC " and " Slightly symptomatic "
Diurnal VOC
Polysomnography and blood sample
Blood collection is a specific intervention of protocol for the 3 arms. Polysomnography is a specific intervention for the arms " Diurnal VOC " and " Slightly symptomatic "
Slightly symptomatic
Polysomnography and blood sample
Blood collection is a specific intervention of protocol for the 3 arms. Polysomnography is a specific intervention for the arms " Diurnal VOC " and " Slightly symptomatic "
Interventions
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Polysomnography and blood sample
Blood collection is a specific intervention of protocol for the 3 arms. Polysomnography is a specific intervention for the arms " Diurnal VOC " and " Slightly symptomatic "
Eligibility Criteria
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Inclusion Criteria
* night VOC ≥ 2 in the previous year
* written informed consent
Daytime VOC Group:
* VOC no nocturnal
* diurnal VOC ≥ 2 in the previous year
* written informed consent
Slightly symptomatic group:
* no hospitalization for VOC
* written informed consent
Exclusion Criteria
* Taking medication that alters sleep (antidepressants, benzodiazepines ...)
* Known history of sleep apnea syndrome
* Known history of serious psychiatric disorder
* Recent vaso-occlusive crisis (within 3 weeks)
* Changes in background treatment (Hydrea or exchange transfusions) in the past 12 months
* Inactive affiliation to social security
* Under legal protection
* A female who is pregnant or breastfeeding
* Prisoners
* Emergency situation
* Refusing to participate in the study
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Anoosha Habibi, MD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Henri Mondor Hospital
Créteil, , France
Countries
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Other Identifiers
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P111121
Identifier Type: -
Identifier Source: org_study_id
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