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

A

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Sickle Cell Disease

Treatments

Other: Polysomnography and blood sample

Study type

Interventional

Funder types

Other

Identifiers

NCT02539771
P111121

Details and patient eligibility

About

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.

Enrollment

114 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

114 participants in 3 patient groups

Nocturnal VOC
Other group
Treatment:
Other: Polysomnography and blood sample
Diurnal VOC
Other group
Treatment:
Other: Polysomnography and blood sample
Slightly symptomatic
Other group
Treatment:
Other: Polysomnography and blood sample

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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