Sleep Apnea in Sickle Cell Disease (DREPAPNEE)

Civil Hospices of Lyon

Status: Terminated

Conditions: Sickle Cell Disease

Treatments: Other: Continuous Positive Airway Pressure; Biological: calculation of VOC frequency between the first polysomnography and the end of the first year of continuous positive airway pressure treatment; Diagnostic Test: polysomnography and oxygen saturation exam; Other: Physiological measurements; Biological: Blood samples

Study type: Interventional

Funder types: Other

Identifiers

NCT03753854

69HCL17_0784

2017-A03352-51 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 15 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

SS patients

Active Comparator group

Description:

Homozygous sickle cell patients Each patient will undergo the following: 1. polysomnography and oxygen saturation exam 2. calculation of VOC rate within the two previous years 3. Blood samples 4. Physiological measurements

Treatment:

Biological: Blood samples

Biological: calculation of VOC frequency between the first polysomnography and the end of the first year of continuous positive airway pressure treatment

Diagnostic Test: polysomnography and oxygen saturation exam

Other: Physiological measurements

SS patients apneic

Experimental group

Description:

Homozygous sickle cell patients after one year of continuous positive airway pressure treatment Each patient will undergo the following: 1. polysomnography and oxygen saturation exam 2. calculation of VOC rate within the two previous years 3. Blood samples 4. Physiological measurements

Treatment:

Biological: Blood samples

Biological: calculation of VOC frequency between the first polysomnography and the end of the first year of continuous positive airway pressure treatment

Diagnostic Test: polysomnography and oxygen saturation exam

Other: Continuous Positive Airway Pressure

Other: Physiological measurements