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

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

Study Overview

• Status: Recruiting
• Conditions: Sleep Disorder; Cognitive Impairment; Obstructive Sleep Apnea; Cognitive Change; Neurologic Signs; Well-Being, Psychological
• Intervention / Treatment: Device: Continuous Positive Airway Pressure Ventilotherapy

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 Type: Observational
• Enrollment (Estimated): 65

Contacts and Locations

• Study Contact: Name: Sofia Tagini, PhD; Phone Number: 00393339915288; Email: s.tagini@auxologico.it

Study Locations

• Italy
  • VCO
    • Piancavallo, VCO, Italy, 28824
      • Recruiting
      • IRCCS Istituto Auxologico Italiano
      • Contact: Sofia Tagini, PhD; Phone Number: 00393339915288; Email: s.tagini@auxologico.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Individual affected by OSAS

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall cognitive functioning	Montreal Cognitive Assessment MoCA (score range: 0-30; higher scores indicate higher cognitive functioning)	baseline and after 3 weeks
Selective attention	Multiple Features Target Cancellation (MFTC) test (accuracy score range from 0 to 1; higher score suggest better performance)	baseline and after 3 weeks
Memory and learning	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.	baseline and after 3 weeks
Visuo-spatial abilities	Rey Figure - copy: test score range from 0 to 36, higher scores indicate better performance	baseline and after 3 weeks
Inhibition	Stroop Test: higher time scores and error scores indicate worst inhibitory control	baseline and after 3 weeks
Planning	Tower of London - ToL: higher time score ( 0-36) and accuracy score (0-36) indicate better performance	baseline and after 3 weeks
Decision making	Balloon Analog Risk Task - BART (test score)	baseline and after 3 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Istituto Auxologico Italiano

Study record dates

Study Major Dates

• Study Start (Actual): February 29, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: March 8, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Wake Disorders; Apnea; Neurologic Manifestations
• Other Study ID Numbers: 21C403

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No