Sickle Cell Disease
Conditions
Keywords
vaso-occlusive crisis, obstructive sleep apnea, priapism
Brief summary
Hypothesis is that the occurrence of nocturnal Vaso-Occlusive Crisis (VOC) and priapism in adults might be related to episodes of nocturnal desaturation secondary to a sleep apnea syndrome. Investigator hypothesize that chronic biological consequences of Obstructive Sleep Apnea (hypercoagulability, endothelial dysfunction ...) favour VOC and acute manifestations (nocturnal desaturation) favour nocturnal VOC. 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.
Interventions
OTHERPolysomnography 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
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Night VOC Group: * 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 opioids * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with nocturnal desaturation and patients with OSA | at 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Minimum oxygen saturation level | at 1 year |
| Quantitative analysis of biomarkers in plasma samples | at 1 year |
| Quantitative analysis of proinflammatory and anti-inflammatory cytokines | at 1 year |
| Oxygen desaturation index | at 1 year |
| Apnea-Hypopnea Index | at 1 year |
| Sleep time with arterial oxygen saturation less than 90% | at 1 year |
| Minimum oxygen saturation level during rapid eye movement (REM) sleep in patients with recurrent priapism and in patients who never presented priapism | at 1 year |
Countries
France
Outcome results
None listed