Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02539771
Recruitment Status : Recruiting
First Posted : September 3, 2015
Last Update Posted : June 20, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment Phase
Sickle Cell Disease Other: Polysomnography and blood sample Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Sleep Study in Adult Patients With Major Sickle Cell Disease With Paroxysmal Nocturnal Events
Study Start Date : September 2014
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 "

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 "

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 "




Primary Outcome Measures :
  1. Percentage of patients with nocturnal desaturation and patients with OSA [ Time Frame: at 1 year ]

Secondary Outcome Measures :
  1. Oxygen desaturation index [ Time Frame: at 1 year ]
  2. Minimum oxygen saturation level [ Time Frame: at 1 year ]
  3. Quantitative analysis of biomarkers in plasma samples [ Time Frame: at 1 year ]
  4. Quantitative analysis of proinflammatory and anti-inflammatory cytokines [ Time Frame: at 1 year ]
  5. Minimum oxygen saturation level during rapid eye movement (REM) sleep in patients with recurrent priapism and in patients who never presented priapism [ Time Frame: at 1 year ]
  6. Apnea-Hypopnea Index [ Time Frame: at 1 year ]
  7. Sleep time with arterial oxygen saturation less than 90% [ Time Frame: at 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02539771


Contacts
Layout table for location contacts
Contact: Serge Adnot, MD. PhD (0)1 49 81 26 90 ext +33 serge.adnot@inserm.fr
Contact: Anoosha Habibi, MD (0)1 49 81 27 73 ext +33 anoosha.habibi@hmn.aphp.fr

Locations
Layout table for location information
France
Henri Mondor Hospital Recruiting
Creteil, France, 94010
Contact: Anoosha Habibi, MD    (0)1 49 81 27 73 ext +33    anoosha.habibi@hmn.aphp.fr   
Contact: Serge Adnot, MD. PhD    (0)1 49 81 26 90 ext +33    serge.adnot@inserm.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Layout table for investigator information
Principal Investigator: Anoosha Habibi, MD Assistance Publique - Hôpitaux de Paris

Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02539771     History of Changes
Other Study ID Numbers: P111121
First Posted: September 3, 2015    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017

Keywords provided by Assistance Publique - Hôpitaux de Paris:
vaso-occlusive crisis
obstructive sleep apnea
priapism

Additional relevant MeSH terms:
Layout table for MeSH terms
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn