We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02539771
Recruitment Status : Unknown
Verified June 2017 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : September 3, 2015
Last Update Posted : June 20, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date  ICMJE July 27, 2015
First Posted Date  ICMJE September 3, 2015
Last Update Posted Date June 20, 2017
Study Start Date  ICMJE September 2014
Estimated Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2015)
Percentage of patients with nocturnal desaturation and patients with OSA [ Time Frame: at 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2015)
  • Oxygen desaturation index [ Time Frame: at 1 year ]
  • Minimum oxygen saturation level [ Time Frame: at 1 year ]
  • Quantitative analysis of biomarkers in plasma samples [ Time Frame: at 1 year ]
  • Quantitative analysis of proinflammatory and anti-inflammatory cytokines [ Time Frame: 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 [ Time Frame: at 1 year ]
  • Apnea-Hypopnea Index [ Time Frame: at 1 year ]
  • Sleep time with arterial oxygen saturation less than 90% [ Time Frame: at 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sleep Study in Adult Patients With Major Sickle Cell Disease With Paroxysmal Nocturnal Events
Official Title  ICMJE Sleep Study in Adult Patients With Major Sickle Cell Disease With Paroxysmal Nocturnal Events
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Sickle Cell Disease
Intervention  ICMJE 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 "
Study Arms  ICMJE
  • Nocturnal VOC
    Intervention: Other: Polysomnography and blood sample
  • Diurnal VOC
    Intervention: Other: Polysomnography and blood sample
  • Slightly symptomatic
    Intervention: Other: Polysomnography and blood sample
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 31, 2015)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2018
Estimated Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02539771
Other Study ID Numbers  ICMJE P111121
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Assistance Publique - Hôpitaux de Paris
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anoosha Habibi, MD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP