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NCT Number: NCT06312956

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Continuous Positive Airway Pressure Ventilotherapy

Device

Breathing support device during sleeping

Other names: CPAP

Primary outcomes

  1. Overall cognitive functioning

    Time frame: baseline and after 3 weeks

    Montreal Cognitive Assessment MoCA (score range: 0-30; higher scores indicate higher cognitive functioning)

  2. Selective attention

    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)

  3. Memory and learning

    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.

  4. Visuo-spatial abilities

    Time frame: baseline and after 3 weeks

    Rey Figure - copy: test score range from 0 to 36, higher scores indicate better performance

  5. Inhibition

    Time frame: baseline and after 3 weeks

    Stroop Test: higher time scores and error scores indicate worst inhibitory control

  6. Planning

    Time frame: baseline and after 3 weeks

    Tower of London - ToL: higher time score ( 0-36) and accuracy score (0-36) indicate better performance

  7. Decision making

    Time frame: baseline and after 3 weeks

    Balloon Analog Risk Task - BART (test score)

Secondary outcomes

  1. biomarkers of neurodegeneration

    Time frame: baseline and after 3 weeks

    blood concentration (pg/ml)

  2. psychosocial wellbeing and satisfaction

    Time frame: baseline and after 3 weeks

    Psychological General Well-Being Index (i.e., test scores)

  3. Quality of life (perceived psycho-physical and socio-economic wellbeing and satisfaction)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sofia Tagini, PhD

CONTACT

[email protected]

00393339915288

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Registry information

Acronym: MULTI-OSAS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 15, 2024
Registry last updated
Sep 9, 2025

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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