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

Obstructive Sleep Apnea Clinical Trial

— MULTI-OSAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06312956
• Other study ID #: 21C403
• Status: Recruiting
• Start date: February 29, 2024
• Est. completion date: February 2026

Study information

• Verified date: March 2024
• Source: Istituto Auxologico Italiano
• Contact: Sofia Tagini, PhD
• Phone: 00393339915288
• Email: s.tagini[@]auxologico.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: February 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Apnea
• Cognitive Change
• Cognitive Impairment
• Neurologic Manifestations
• Neurologic Signs
• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive
• Sleep Disorder
• Sleep Wake Disorders

Intervention

Device:
• Continuous Positive Airway Pressure Ventilotherapy
Breathing support device during sleeping

Locations

Country	Name	City	State
Italy	IRCCS Istituto Auxologico Italiano	Piancavallo	VCO

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall cognitive functioning	Montreal Cognitive Assessment MoCA (score range: 0-30; higher scores indicate higher cognitive functioning)	baseline and after 3 weeks
Primary	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
Primary	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
Primary	Visuo-spatial abilities	Rey Figure - copy: test score range from 0 to 36, higher scores indicate better performance	baseline and after 3 weeks
Primary	Inhibition	Stroop Test: higher time scores and error scores indicate worst inhibitory control	baseline and after 3 weeks
Primary	Planning	Tower of London - ToL: higher time score ( 0-36) and accuracy score (0-36) indicate better performance	baseline and after 3 weeks
Primary	Decision making	Balloon Analog Risk Task - BART (test score)	baseline and after 3 weeks
Secondary	biomarkers of neurodegeneration	blood concentration (pg/ml)	baseline and after 3 weeks
Secondary	psychosocial wellbeing and satisfaction	Psychological General Well-Being Index (i.e., test scores)	baseline and after 3 weeks
Secondary	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