Clinical trial NCT06312956: Multidimensional Evaluation of Patients' Affected by Obstructive Apnea Syndrome (OSAS) Before and After Ventilotherapy
Official title: Multidimensional Evaluation of Patients' Affected by Obstructive Apnea Syndrome (OSAS) Before and After Ventilotherapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obstructive Sleep Apnea
Sleep Disorder
Well-Being, Psychological
Cognitive Impairment
Cognitive Change
Neurologic Signs
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 65
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individual affected by 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

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.

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)

Primary outcomes:
measure: Overall cognitive functioning
timeFrame: baseline and after 3 weeks
measure: Selective attention
timeFrame: baseline and after 3 weeks
measure: Memory and learning
timeFrame: baseline and after 3 weeks
measure: Visuo-spatial abilities
timeFrame: baseline and after 3 weeks
measure: Inhibition
timeFrame: baseline and after 3 weeks
measure: Planning
timeFrame: baseline and after 3 weeks
measure: Decision making
timeFrame: baseline and after 3 weeks
Secondary outcomes:
measure: biomarkers of neurodegeneration
timeFrame: baseline and after 3 weeks
measure: psychosocial wellbeing and satisfaction
timeFrame: baseline and after 3 weeks
measure: Quality of life (perceived psycho-physical and socio-economic wellbeing and satisfaction)
timeFrame: baseline and after 3 weeks
Other outcomes:
Locations:
city: Piancavallo
country: Italy
facility: IRCCS Istituto Auxologico Italiano
state: VCO
Study officials:
References: