Sleep Study in Adult Patients With Major Sickle Cell Disease With Paroxysmal Nocturnal Events

Study Overview
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Brief Summary
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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.

Official Title
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Sleep Study in Adult Patients With Major Sickle Cell Disease With Paroxysmal Nocturnal Events

Conditions
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Sickle Cell Disease

Intervention / Treatment
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* Other: Polysomnography and blood sample


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Nocturnal VOC<br> | Other: Polysomnography and blood sample<br>* 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 <br>|
| Other: Diurnal VOC<br> | Other: Polysomnography and blood sample<br>* 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 <br>|
| Other: Slightly symptomatic<br> | Other: Polysomnography and blood sample<br>* 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 <br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with nocturnal desaturation and patients with OSA |  | at 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen desaturation index |  | at 1 year | 
| 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 | 
| 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 | 
| Apnea-Hypopnea Index |  | at 1 year | 
| Sleep time with arterial oxygen saturation less than 90% |  | at 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaso-occlusive crisis, obstructive sleep apnea, priapism