Clinical trial NCT02539771: Sleep Study in Adult Patients With Major Sickle Cell Disease With Paroxysmal Nocturnal Events
Official title: Sleep Study in Adult Patients With Major Sickle Cell Disease With Paroxysmal Nocturnal Events
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Disease
Keywords: vaso-occlusive crisis
obstructive sleep apnea
priapism
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2015-09-03
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients with nocturnal desaturation and patients with OSA
timeFrame: at 1 year
Secondary outcomes:
measure: Oxygen desaturation index
timeFrame: at 1 year
measure: Minimum oxygen saturation level
timeFrame: at 1 year
measure: Quantitative analysis of biomarkers in plasma samples
timeFrame: at 1 year
measure: Quantitative analysis of proinflammatory and anti-inflammatory cytokines
timeFrame: at 1 year
measure: Minimum oxygen saturation level during rapid eye movement (REM) sleep in patients with recurrent priapism and in patients who never presented priapism
timeFrame: at 1 year
measure: Apnea-Hypopnea Index
timeFrame: at 1 year
measure: Sleep time with arterial oxygen saturation less than 90%
timeFrame: at 1 year
Other outcomes:
Locations:
city: Creteil
country: France
facility: Henri Mondor Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Anoosha Habibi, MD
role: PRINCIPAL_INVESTIGATOR
References: