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

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.

Study Overview

• Status: Completed
• Conditions: Sickle Cell Disease
• Intervention / Treatment: Other: Polysomnography and blood sample

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Creteil, France, 94010
    • Henri Mondor Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Nocturnal VOC	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 "
Other: Diurnal VOC	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 "
Other: Slightly symptomatic	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 "

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Anoosha Habibi, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2014
• Primary Completion (Actual): April 10, 2019
• Study Completion (Actual): April 10, 2019

Study Registration Dates

• First Submitted: July 27, 2015
• First Submitted That Met QC Criteria: August 31, 2015
• First Posted (Estimate): September 3, 2015

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: vaso-occlusive crisis; obstructive sleep apnea; priapism
• Additional Relevant MeSH Terms: Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Anemia, Sickle Cell
• Other Study ID Numbers: P111121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: DATAS ARE OWNED BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No