Cognitive Change, Cognitive Impairment, Neurologic Signs, Obstructive Sleep Apnea, Sleep Disorder, Well-Being, Psychological
Conditions
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
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
DEVICEContinuous Positive Airway Pressure Ventilotherapy
Breathing support device during sleeping
Sponsors
Istituto Auxologico Italiano
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decision making | baseline and after 3 weeks | Balloon Analog Risk Task - BART (test score) |
| Visuo-spatial abilities | baseline and after 3 weeks | Rey Figure - copy: test score range from 0 to 36, higher scores indicate better performance |
| Inhibition | baseline and after 3 weeks | Stroop Test: higher time scores and error scores indicate worst inhibitory control |
| Planning | baseline and after 3 weeks | Tower of London - ToL: higher time score ( 0-36) and accuracy score (0-36) indicate better performance |
| Overall cognitive functioning | baseline and after 3 weeks | Montreal Cognitive Assessment MoCA (score range: 0-30; higher scores indicate higher cognitive functioning) |
| Selective attention | baseline and after 3 weeks | Multiple Features Target Cancellation (MFTC) test (accuracy score range from 0 to 1; higher score suggest better performance) |
| Memory and learning | baseline and after 3 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| psychosocial wellbeing and satisfaction | baseline and after 3 weeks | Psychological General Well-Being Index (i.e., test scores) |
| Quality of life (perceived psycho-physical and socio-economic wellbeing and satisfaction) | baseline and after 3 weeks | 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. |
| biomarkers of neurodegeneration | baseline and after 3 weeks | blood concentration (pg/ml) |
Countries
Italy
Contacts
Primary ContactSofia Tagini, PhD
Outcome results
None listed