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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 Summary:
Sponsor: Assistance Publique - Hôpitaux de Paris

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: July 27, 2015
Date Started: September 2014
Date Completion: September 2018
Last Updated: August 31, 2015
Last Verified: July 2015