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

Sickle Cell Disease Clinical Trial

— DREPASOM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02539771
• Other study ID #: P111121
• Status: Completed
• Phase: N/A
• Start date: September 17, 2014
• Est. completion date: April 10, 2019

Study information

• Verified date: May 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: April 10, 2019
• Est. primary completion date: April 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

Other:
• 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 "

Locations

Country	Name	City	State
France	Henri Mondor Hospital	Creteil

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with nocturnal desaturation and patients with OSA		at 1 year
Secondary	Oxygen desaturation index		at 1 year
Secondary	Minimum oxygen saturation level		at 1 year
Secondary	Quantitative analysis of biomarkers in plasma samples		at 1 year
Secondary	Quantitative analysis of proinflammatory and anti-inflammatory cytokines		at 1 year
Secondary	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
Secondary	Apnea-Hypopnea Index		at 1 year
Secondary	Sleep time with arterial oxygen saturation less than 90%		at 1 year