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

Recruiting

• Conditions: Well-Being, Psychological; Cognitive Impairment; Cognitive Change; Neurologic Signs; Obstructive Sleep Apnea; Sleep Disorder

• Registration Number: NCT06312956
• Lead Sponsor: Istituto Auxologico Italiano

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.

Study Timeline

• Study First Submitted: 2024-02-21
• Study Start: 2024-02-29
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-08
• Last Update Submitted: 2024-03-08
• Study First Posted: 2024-03-15
• Last Update Posted: 2024-03-15
• Primary Completion: 2025-06
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• OSAS diagnosis (AHI > 5)
• handedness: right

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Exclusion Criteria

• previous ventilotherapy
• neurological and/or neurodegenerative conditions
• Personality disorders, autism spectrum disorders, schizophrenia, psychosis
• sleep disorders comorbidities (eg., narcolepsy)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Planning	baseline and after 3 weeks	Tower of London - ToL: higher time score ( 0-36) and accuracy score (0-36) indicate better performance
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)
Inhibition	baseline and after 3 weeks	Stroop Test: higher time scores and error scores indicate worst inhibitory control
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.
Overall cognitive functioning	baseline and after 3 weeks	Montreal Cognitive Assessment MoCA (score range: 0-30; higher scores indicate higher cognitive functioning)
Visuo-spatial abilities	baseline and after 3 weeks	Rey Figure - copy: test score range from 0 to 36, higher scores indicate better performance
Decision making	baseline and after 3 weeks	Balloon Analog Risk Task - BART (test score)

Secondary Outcome Measures

Name	Time	Method
Quality of life (perceived psycho-physical and socio-economic wellbeing and satisfaction)	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.
biomarkers of neurodegeneration	baseline and after 3 weeks	blood concentration (pg/ml)
psychosocial wellbeing and satisfaction	baseline and after 3 weeks	Psychological General Well-Being Index (i.e., test scores)

Trial Locations

Locations (1)

IRCCS Istituto Auxologico Italiano; 🇮🇹 Piancavallo, VCO, Italy