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

NCT02539771 | Completed

• 1 other identifier: P111121
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease

Keywords

vaso-occlusive crisis; obstructive sleep apnea; priapism

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with nocturnal desaturation and patients with OSA

  at 1 year

Secondary Outcomes (7)

• 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

Study Arms (3)

Nocturnal VOC

OTHER

Other: Polysomnography and blood sample

Diurnal VOC

OTHER

Other: Polysomnography and blood sample

Slightly symptomatic

OTHER

Other: Polysomnography and blood sample

Interventions

Polysomnography and blood sample OTHER

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 "

Diurnal VOC; Nocturnal VOC; Slightly symptomatic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Henri Mondor Hospital

Créteil, 94010, France

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Vaso-Occlusive Crises; Sleep Apnea, Obstructive; Priapism

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Anoosha Habibi, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2015
• First Posted: September 3, 2015
• Study Start: September 17, 2014
• Primary Completion: April 10, 2019
• Study Completion: April 10, 2019
• Last Updated: May 19, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)