Sleep Apnea in Sickle Cell Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-28

Study Completion Date

2021-11-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Sickle Cell Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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SS patients apneic

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

Group Type EXPERIMENTAL

polysomnography and oxygen saturation exam

Intervention Type DIAGNOSTIC_TEST

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

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

Intervention Type BIOLOGICAL

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

Blood samples

Intervention Type BIOLOGICAL

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

Physiological measurements

Intervention Type OTHER

Evaluation of microvascular reactivity and autonomic nervous system activity

Continuous Positive Airway Pressure

Intervention Type OTHER

Continuous Positive Airway Pressure during 1 year

SS patients

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

Group Type ACTIVE_COMPARATOR

polysomnography and oxygen saturation exam

Intervention Type DIAGNOSTIC_TEST

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

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

Intervention Type BIOLOGICAL

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

Blood samples

Intervention Type BIOLOGICAL

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

Physiological measurements

Intervention Type OTHER

Evaluation of microvascular reactivity and autonomic nervous system activity

Interventions

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polysomnography and oxygen saturation exam

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

Intervention Type DIAGNOSTIC_TEST

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

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

Intervention Type BIOLOGICAL

Blood samples

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

Intervention Type BIOLOGICAL

Physiological measurements

Evaluation of microvascular reactivity and autonomic nervous system activity

Intervention Type OTHER

Continuous Positive Airway Pressure

Continuous Positive Airway Pressure during 1 year

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

15 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No