About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
OSAS diagnosis (AHI > 5)
handedness: right
Disqualifiers
previous ventilotherapy
neurological and/or neurodegenerative conditions
Personality disorders, autism spectrum disorders, schizophrenia, psychosis
sleep disorders comorbidities (eg., narcolepsy)
Trial population
Individual affected by OSAS
Trial design
Case-only
Prospective
Treatments tested in this trial
Continuous Positive Airway Pressure Ventilotherapy
DeviceBreathing support device during sleeping
Treatment groups
Trial outcomes
Primary outcomes
Overall cognitive functioning
Montreal Cognitive Assessment MoCA (score range: 0-30; higher scores indicate higher cognitive functioning)
Selective attention
Multiple Features Target Cancellation (MFTC) test (accuracy score range from 0 to 1; higher score suggest better performance)
Memory and learning
Selective Reminding Test - SRT: three scores are provided. 1) long term memory storage capacity (0-72), learning (0-72), delayed recall (0-12). Higher scores indicate better performance.
Visuo-spatial abilities
Rey Figure - copy: test score range from 0 to 36, higher scores indicate better performance
Secondary outcomes
biomarkers of neurodegeneration
blood concentration (pg/ml)
psychosocial wellbeing and satisfaction
Psychological General Well-Being Index (i.e., test scores)
Quality of life (perceived psycho-physical and socio-economic wellbeing and satisfaction)
Quality of Life Scale: 16-items self-report scored from 1 - terrible to 7 - delighted (score range 16-112); higher score indicate higher wellbeing and satisfaction.
Sponsors and contacts
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