Obstructive Sleep ApneaMULTI-OSASNCT06312956
Multidimensional Evaluation of Patients' Affected by Obstructive Apnea Syndrome (OSAS) Before and After Ventilotherapy
An observational study of Obstructive Sleep Apnea and Sleep Disorder, run by Istituto Auxologico Italiano at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Obstructive Sleep Apnea, Sleep Disorder, Well-Being, Psychological
- What is being tested?
- Continuous Positive Airway Pressure Ventilotherapy
- Type of treatment
- Medical device
- How many people
- 65 participants
- Where
- 1 siteItaly
- Study dates
- 29 Feb 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Individual affected by OSAS
Who may be able to join
- OSAS diagnosis (AHI > 5)
- handedness: right
Who cannot join
- previous ventilotherapy
- neurological and/or neurodegenerative conditions
- Personality disorders, autism spectrum disorders, schizophrenia, psychosis
- sleep disorders comorbidities (eg., narcolepsy)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Istituto Auxologico Italiano
Piancavallo, VCO, 28824
Sofia Tagini, PhD, 00393339915288, s.tagini@auxologico.it
About this study
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
Read the 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.
- Conditions
- Obstructive Sleep Apnea, Sleep Disorder, Well-Being, Psychological, Cognitive Impairment, Cognitive Change, Neurologic Signs
- Being tested
- Continuous Positive Airway Pressure Ventilotherapy
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Wake Disorders, Psychological Well-Being, Cognitive Dysfunction, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Positive Airway Pressure VentilotherapyDevice
Also called CPAP
Breathing support device during sleeping
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall cognitive functioning
Montreal Cognitive Assessment MoCA (score range: 0-30; higher scores indicate higher cognitive functioning)
Measured: 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)
Measured: 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.
Measured: baseline and after 3 weeks
Visuo-spatial abilities
Rey Figure - copy: test score range from 0 to 36, higher scores indicate better performance
Measured: baseline and after 3 weeks
Inhibition
Stroop Test: higher time scores and error scores indicate worst inhibitory control
Measured: baseline and after 3 weeks
Planning
Tower of London - ToL: higher time score ( 0-36) and accuracy score (0-36) indicate better performance
Measured: baseline and after 3 weeks
Decision making
Balloon Analog Risk Task - BART (test score)
Measured: baseline and after 3 weeks
Secondary outcomes (3)
biomarkers of neurodegeneration
blood concentration (pg/ml)
Measured: baseline and after 3 weeks
psychosocial wellbeing and satisfaction
Psychological General Well-Being Index (i.e., test scores)
Measured: 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.
Measured: baseline and after 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start29 Feb 2024
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312956
- Sponsor's protocol ID
- 21C403
- Acronym
- MULTI-OSAS
- Status last verified
- Sep 2025
- First submitted
- 21 Feb 2024
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidimensional Evaluation of Patients' Affected by Obstructive Apnea Syndrome (OSAS) Before and After Ventilotherapy
- ClinicalTrials.gov ID
- NCT06312956
- Acronym / sponsor ID
- MULTI-OSAS / 21C403
- Conditions
- Obstructive Sleep Apnea, Sleep Disorder, Well-Being, Psychological, Cognitive Impairment, Cognitive Change, Neurologic Signs
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Individual affected by OSAS
Key inclusion criteria (2 listed)
- OSAS diagnosis (AHI > 5)
- handedness: right
Key exclusion criteria (4 listed)
- previous ventilotherapy
- neurological and/or neurodegenerative conditions
- Personality disorders, autism spectrum disorders, schizophrenia, psychosis
- sleep disorders comorbidities (eg., narcolepsy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Positive Airway Pressure VentilotherapyAlso: CPAPBreathing support device during sleeping | Device | – |
Primary outcome
Overall cognitive functioning
Time frame: baseline and after 3 weeks
Montreal Cognitive Assessment MoCA (score range: 0-30; higher scores indicate higher cognitive functioning)
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)
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.
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
Inhibition
Time frame: baseline and after 3 weeks
Stroop Test: higher time scores and error scores indicate worst inhibitory control
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
Decision making
Time frame: baseline and after 3 weeks
Balloon Analog Risk Task - BART (test score)
3 secondary outcomes
biomarkers of neurodegeneration
Time frame: baseline and after 3 weeks
psychosocial wellbeing and satisfaction
Time frame: baseline and after 3 weeks
Quality of life (perceived psycho-physical and socio-economic wellbeing and satisfaction)
Time frame: baseline and after 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and Sleep Disorder, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sofia Tagini, PhD (00393339915288, s.tagini@auxologico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall cognitive functioning (time frame: baseline and after 3 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.