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Multidimensional Evaluation of Patients' Affected by Obstructive Apnea Syndrome (OSAS) Before and After Ventilotherapy (MULTI-OSAS)

I

Istituto Auxologico Italiano

Status

Enrolling

Conditions

Cognitive Change
Cognitive Impairment
Neurologic Signs
Sleep Disorder
Obstructive Sleep Apnea
Well-Being, Psychological

Treatments

Device: Continuous Positive Airway Pressure Ventilotherapy

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

65 estimated patients

Sex

All

Ages

20 to 60 years old

Volunteers

No Healthy Volunteers

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)

Trial contacts and locations

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Central trial contact

Sofia Tagini, PhD

Data sourced from clinicaltrials.gov

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