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

Condition(s) studied

Investigational drug(s) / intervention(s)

Continuous Positive Airway Pressure Ventilotherapy: Breathing support device during sleeping

Study 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

Eligibility

Primary outcome measure(s)

• 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.
• 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
• Decision making — baseline and after 3 weeks
  Balloon Analog Risk Task - BART (test score)

Trial sites (1)

More Istituto Auxologico Italiano trials in Italy

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