Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06312956
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-02-21
Brief Title:
Multidimensional Evaluation of Patients Affected by Obstructive Apnea Syndrome OSAS Before and After Ventilotherapy
Sponsor:
Istituto Auxologico Italiano
Organization:
Istituto Auxologico Italiano
Study Overview
Official Title:
Multidimensional Evaluation of Patients Affected by Obstructive Apnea Syndrome OSAS Before and After Ventilotherapy
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MULTI-OSAS
Brief Summary:
This observational study aims to evaluate multiple dimensions of health in patients with Obstructive Sleep Apnea Syndrome OSAS before and after three weeks of ventilotherapy
Specifically the study aims to identify pre- vs post-treatment differences in the following domains
cognitive performance
blood expression of biomarkers related to neurodegeneration
psychosocial wellbeing
Thus patients will complete the following evaluations before T0 and after T1 ventilotherapy
neuropsychological standard assessment
blood sampling
psychosocial self-reported questionnaires
Specifically the study aims to identify pre- vs post-treatment differences in the following domains
cognitive performance
blood expression of biomarkers related to neurodegeneration
psychosocial wellbeing
Thus patients will complete the following evaluations before T0 and after T1 ventilotherapy
neuropsychological standard assessment
blood sampling
psychosocial self-reported questionnaires
Detailed Description:
Obstructive Sleep Apnea Syndrome is associated with cognitive difficulties low psychosocial wellbeing and quality of life however the possible beneficial contribution of ventilotherapy on these dimensions is not completely clear Ventilotherapy restores brain oxygenation and improve rest possibly increasing cognitive performances psychosocial health and quality of life Multidisciplinary approaches to the treatment of OSAS are rare although recommended Solid proof of OSAS comorbidities may encourage clinicians to adopt a holistic perspective of care leading to better rehabilitative outcomes Also evidence of the beneficial effects of ventilotherapy could increase patients compliance to ventilotherapy which is generally low
The study aims to evaluate multiple dimensions of patients health before and after three weeks of ventilotherapy focusing on the cognitive performance the blood expression of biomarkers related to neurodegeneration and individuals psychosocial wellbeing
Overall it is expected improved cognitive performances and psychosocial wellbeing after ventilotherapy Also a reduction in the blood expression of biomarkers related to neurodegeneration if found before the treatment is hypothesized although the limited research in this field requires cautious predictions
Comprehensive evidence about OSAS comorbidity beyond breath and sleep difficulties is mandatory to design innovative multidisciplinary rehabilitative approaches in line with a holistic perspective of care Effective multidisciplinary approaches are considered the gold standard in medical care leading to better treatment outcomes and higher patients satisfaction
Beyond the clear ethical implication of providing higher quality of treatment multidisciplinary interventions also imply a shared responsibility of treatment preventing from clinical misjudgments and professionals burnout
The study aims to evaluate multiple dimensions of patients health before and after three weeks of ventilotherapy focusing on the cognitive performance the blood expression of biomarkers related to neurodegeneration and individuals psychosocial wellbeing
Overall it is expected improved cognitive performances and psychosocial wellbeing after ventilotherapy Also a reduction in the blood expression of biomarkers related to neurodegeneration if found before the treatment is hypothesized although the limited research in this field requires cautious predictions
Comprehensive evidence about OSAS comorbidity beyond breath and sleep difficulties is mandatory to design innovative multidisciplinary rehabilitative approaches in line with a holistic perspective of care Effective multidisciplinary approaches are considered the gold standard in medical care leading to better treatment outcomes and higher patients satisfaction
Beyond the clear ethical implication of providing higher quality of treatment multidisciplinary interventions also imply a shared responsibility of treatment preventing from clinical misjudgments and professionals burnout
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None