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

Not Applicable

Completed

• Conditions: Sickle Cell Disease
• Interventions: Other: Polysomnography and blood sample

• Registration Number: NCT02539771
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-17
• Study First Submitted: 2015-07-27
• Study First Submitted QC: 2015-08-31
• Study First Posted: 2015-09-03
• Primary Completion: 2019-04-10
• Study Completion: 2019-04-10
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-17
• Last Update Posted: 2023-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nocturnal VOC	Polysomnography and blood sample	-
Diurnal VOC	Polysomnography and blood sample	-
Slightly symptomatic	Polysomnography and blood sample	-

Primary Outcome Measures

Name	Time	Method
Percentage of patients with nocturnal desaturation and patients with OSA	at 1 year

Secondary Outcome Measures

Name	Time	Method
Apnea-Hypopnea Index	at 1 year
Oxygen desaturation index	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	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
Sleep time with arterial oxygen saturation less than 90%	at 1 year

Trial Locations

Locations (1)

Henri Mondor Hospital; 🇫🇷 Creteil, France