Clinical trial NCT03753854: Sleep Apnea in Sickle Cell Disease
Official title: Effects of Obstructive Sleep Apnea on the Frequency of Vaso-occlusive Crises Events and Bio-physical Markers in Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sickle Cell Disease
Keywords: sickle cell disease
obstructive sleep apnoea
vaso-occlusive crisis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 30
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Despite the fact that obstructive sleep apnoea (OSA) is highly prevalent in the sickle cell population, studies focusing on the associations of the two diseases and their common pathophysiological mechanisms are scarce. OSA is one of the most common conditions responsible for hemoglobin desaturation. The nocturnal hemoglobin desaturation occurring in some sickle cell disease (SCD) patients with OSA could trigger hemoglobin S polymerization and red blood cell (RBC) sickling, leading to further blood rheological alterations, hence increasing the risks for VOC. Moreover, OSA has been demonstrated to increase oxidative stress and inflammation in non Sickle Cell Disease (SCD) patients, which, in SCD patients, could increase the risk for complications. Finally, OSA is accompanied by impaired vascular function and autonomic nervous system dysfunction in the general population. Indeed, the presence of OSA in SCD could increase the clinical severity of patients and the frequency of VOC.


Eligibility criteria: Inclusion Criteria:

* Homozygous HbS (Hemoglobin S) (SS) patients,
* aged between 15 and 3 months and 50 years old,
* in steady state (i.e. without vaso-occlusive crisis or recent blood transfusion),
* followed by the sickle cell center of the Hospices Civils de Lyon,
* and showing symptoms of OSA.

Exclusion Criteria:

* Patients receiving treatment of OSA,
* recent blood transfusion (less than 2 months),
* patients not at steady state (VOC or acute chest syndrome less than 2 months),
* pregnancy.

Primary outcomes:
measure: number of VOC crises required hospitalization in the previous two years
timeFrame: day 1
Secondary outcomes:
measure: Blood inflammatory markers
timeFrame: An average of 1 month
measure: Blood inflammatory markers
timeFrame: Day 365
measure: Markers of blood coagulation
timeFrame: An average of 1 month
measure: Markers of blood coagulation
timeFrame: Day 365
measure: Blood cell counts and markers of hemolysis
timeFrame: An average of 1 month
measure: Blood cell counts and markers of hemolysis
timeFrame: Day 365
measure: Markers of nitric oxide metabolism
timeFrame: An average of 1 month
measure: Markers of nitric oxide metabolism
timeFrame: Day 365
measure: Oxidative stress markers
timeFrame: An average of 1 month
measure: Oxidative stress markers
timeFrame: Day 365
measure: Hemorheological parameters
timeFrame: An average of 1 month
measure: Hemorheological parameters
timeFrame: Day 365
measure: Arterial blood gases
timeFrame: An average of 1 month
measure: Arterial blood gases
timeFrame: Day 365
measure: Vascular function (microvascular reactivity to skin heating test)
timeFrame: Day 1
measure: Vascular function (microvascular reactivity to skin heating test)
timeFrame: Day 365
measure: autonomic nervous system activity (measured by heart rate variability analysis)
timeFrame: Day 1
measure: autonomic nervous system activity (measured by heart rate variability analysis)
timeFrame: Day 365
measure: Frequency of VOC
timeFrame: Day 365
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Edouard Herriot
city: Lyon
country: France
facility: Centre Léon Berard
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
Study officials:
References:
citation: Stauffer E, Poutrel S, Cannas G, Gauthier A, Fort R, Bertrand Y, Renoux C, Joly P, Boisson C, Hot A, Peter-Derex L, Pialoux V, PetitJean T, Connes P. Nocturnal Hypoxemia Rather Than Obstructive Sleep Apnea Is Associated With Decreased Red Blood Cell Deformability and Enhanced Hemolysis in Patients With Sickle Cell Disease. Front Physiol. 2021 Sep 24;12:743399. doi: 10.3389/fphys.2021.743399. eCollection 2021.