Multidimensional Evaluation of Patients' Affected by Obstructive Apnea Syndrome (OSAS) Before and After Ventilotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Continuous Positive Airway Pressure Ventilotherapy.
- Who it may be relevant to
- Registry conditions: Obstructive Sleep Apnea, Sleep Disorder, Well-Being, Psychological, Cognitive Impairment. Basic parameters: 20 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
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 patient's health before and after three weeks of ventilotherapy, focusing on the cognitive performance, the blood expression of biomarkers related to neurodegeneration, and individual's 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.
Interventions
- Device Continuous Positive Airway Pressure Ventilotherapy
Breathing support device during sleeping
Primary outcome measures
- Overall cognitive functioning [Time frame: baseline and after 3 weeks]
- Selective attention [Time frame: baseline and after 3 weeks]
- Memory and learning [Time frame: baseline and after 3 weeks]
- Visuo-spatial abilities [Time frame: baseline and after 3 weeks]
- Inhibition [Time frame: baseline and after 3 weeks]
- Planning [Time frame: baseline and after 3 weeks]
- Decision making [Time frame: baseline and after 3 weeks]
Secondary outcome measures (3)
- biomarkers of neurodegeneration [Time frame: baseline and after 3 weeks]
- psychosocial wellbeing and satisfaction [Time frame: baseline and after 3 weeks]
- Quality of life (perceived psycho-physical and socio-economic wellbeing and satisfaction) [Time frame: baseline and after 3 weeks]
Eligibility criteria
Inclusion criteria
- OSAS diagnosis (AHI > 5)
- handedness: right
Exclusion criteria
- previous ventilotherapy
- neurological and/or neurodegenerative conditions
- Personality disorders, autism spectrum disorders, schizophrenia, psychosis
- sleep disorders comorbidities (eg., narcolepsy)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Italy · 1 center
- IRCCS Istituto Auxologico Italiano — Piancavallo
Identifiers
NCT: NCT06312956 · 21C403