Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
30 participants
INTERVENTIONAL
2018-05-28
2021-11-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
polysomnography and oxygen saturation exam
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
calculation of VOC rate within the two previous years or between first polysomnography and one year of continuous positive airway pressure treatment
Blood samples
Blood samples with measurements of hematological, hemorheological, inflammatory and blood coagulation markers
Physiological measurements
Evaluation of microvascular reactivity and autonomic nervous system activity
Continuous Positive Airway Pressure
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
polysomnography and oxygen saturation exam
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
calculation of VOC rate within the two previous years or between first polysomnography and one year of continuous positive airway pressure treatment
Blood samples
Blood samples with measurements of hematological, hemorheological, inflammatory and blood coagulation markers
Physiological measurements
Evaluation of microvascular reactivity and autonomic nervous system activity
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
polysomnography and oxygen saturation exam
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
calculation of VOC rate within the two previous years or between first polysomnography and one year of continuous positive airway pressure treatment
Blood samples
Blood samples with measurements of hematological, hemorheological, inflammatory and blood coagulation markers
Physiological measurements
Evaluation of microvascular reactivity and autonomic nervous system activity
Continuous Positive Airway Pressure
Continuous Positive Airway Pressure during 1 year
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* recent blood transfusion (less than 2 months),
* patients not at steady state (VOC or acute chest syndrome less than 2 months),
* pregnancy.
15 Years
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospices Civils de Lyon
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hôpital Edouard Herriot
Lyon, , France
Centre Léon Berard
Lyon, , France
Hôpital de la Croix Rousse
Lyon, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2017-A03352-51
Identifier Type: OTHER
Identifier Source: secondary_id
69HCL17_0784
Identifier Type: -
Identifier Source: org_study_id