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

NCT06312956 | Recruiting

• 1 other identifier: 21C403
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (3)

• biomarkers of neurodegeneration

  baseline and after 3 weeks

• psychosocial wellbeing and satisfaction

  baseline and after 3 weeks

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

  baseline and after 3 weeks

Interventions

Continuous Positive Airway Pressure Ventilotherapy DEVICE

Breathing support device during sleeping

Also known as: CPAP

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Individual affected by OSAS

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

IRCCS Istituto Auxologico Italiano

Piancavallo, VCO, 28824, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample for biomarkers analysis (i.e., orexin, histamine, light chain neurofilaments, Ab42, Ab40)

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Wake Disorders; Psychological Well-Being; Cognitive Dysfunction; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Personal Satisfaction; Behavior; Cognition Disorders; Neurocognitive Disorders

Central Study Contacts

Sofia Tagini, PhD

CONTACT

00393339915288; s.tagini@auxologico.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: March 15, 2024
• Study Start: February 29, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)