Sleep Apnea in Sickle Cell Disease

NCT03753854 | Terminated

• 2 other identifiers: 69HCL17_07842017-A03352-51
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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.

Conditions

Sickle Cell Disease

Keywords

sickle cell disease; obstructive sleep apnoea; vaso-occlusive crisis

Outcome Measures

Primary Outcomes (1)

• number of VOC crises required hospitalization in the previous two years

  Calculated over a 2 years period before inclusion. VOC requiring hospitalizations will be recorded. Measured at day 1

  day 1

Secondary Outcomes (19)

• Blood inflammatory markers

  An average of 1 month

• Blood inflammatory markers

  Day 365

• Markers of blood coagulation

  An average of 1 month

• Markers of blood coagulation

  Day 365

• Blood cell counts and markers of hemolysis

  An average of 1 month

Study Arms (2)

SS patients

ACTIVE COMPARATOR

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

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

SS patients apneic

EXPERIMENTAL

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

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

Interventions

polysomnography and oxygen saturation exam DIAGNOSTIC_TEST

Measurement of the Apnea/hypopnea index (AHI) and oxygen saturation

SS patients; SS patients apneic

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

calculation of VOC rate within the two previous years or between first polysomnography and one year of continuous positive airway pressure treatment

SS patients; SS patients apneic

Blood samples BIOLOGICAL

Blood samples with measurements of hematological, hemorheological, inflammatory and blood coagulation markers

SS patients; SS patients apneic

Physiological measurements OTHER

Evaluation of microvascular reactivity and autonomic nervous system activity

SS patients; SS patients apneic

Continuous Positive Airway Pressure OTHER

Continuous Positive Airway Pressure during 1 year

SS patients apneic

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (3)

Hôpital Edouard Herriot

Lyon, 69003, France

Location

Centre Léon Berard

Lyon, 69008, France

Location

Hôpital de la Croix Rousse

Lyon, 69317, France

Location

Related Publications (1)

• 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.

  PMID: 34630163 DERIVED

MeSH Terms

Conditions

Anemia, Sickle Cell; Sleep Apnea, Obstructive; Vaso-Occlusive Crises

Interventions

Polysomnography; Blood Specimen Collection; Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative; Investigative Techniques; Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: November 27, 2018
• Study Start: May 28, 2018
• Primary Completion: November 29, 2021
• Study Completion: November 29, 2021
• Last Updated: December 28, 2022

Record last verified: 2022-12

Locations

FR (3)