IRCCS Istituto Auxologico Italiano
Piancavallo, VCO, 28824, Italy
Location status: Recruiting
NCT Number: NCT06312956
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
Interested in participating?
Request Info20 year–60 year
All sexes
Observational
Piancavallo, VCO, 28824, Italy
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Breathing support device during sleeping
Other names: CPAP
Time frame: baseline and after 3 weeks
Montreal Cognitive Assessment MoCA (score range: 0-30; higher scores indicate higher cognitive functioning)
Time frame: baseline and after 3 weeks
Multiple Features Target Cancellation (MFTC) test (accuracy score range from 0 to 1; higher score suggest better performance)
Time frame: 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.
Time frame: baseline and after 3 weeks
Rey Figure - copy: test score range from 0 to 36, higher scores indicate better performance
Time frame: baseline and after 3 weeks
Stroop Test: higher time scores and error scores indicate worst inhibitory control
Time frame: baseline and after 3 weeks
Tower of London - ToL: higher time score ( 0-36) and accuracy score (0-36) indicate better performance
Time frame: baseline and after 3 weeks
Balloon Analog Risk Task - BART (test score)
Time frame: baseline and after 3 weeks
blood concentration (pg/ml)
Time frame: baseline and after 3 weeks
Psychological General Well-Being Index (i.e., test scores)
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Istituto Auxologico Italiano
Other
Acronym: MULTI-OSAS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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