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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-60
SponsorIstituto Auxologico Italiano

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

OSAS diagnosis (AHI > 5)

handedness: right

Disqualifiers

previous ventilotherapy

neurological and/or neurodegenerative conditions

Personality disorders, autism spectrum disorders, schizophrenia, psychosis

sleep disorders comorbidities (eg., narcolepsy)

Trial population

Individual affected by OSAS

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Continuous Positive Airway Pressure Ventilotherapy

    Device

    Breathing support device during sleeping

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Overall cognitive functioning

Montreal Cognitive Assessment MoCA (score range: 0-30; higher scores indicate higher cognitive functioning)

Time frame
baseline and after 3 weeks
2

Selective attention

Multiple Features Target Cancellation (MFTC) test (accuracy score range from 0 to 1; higher score suggest better performance)

Time frame
baseline and after 3 weeks
3

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.

Time frame
baseline and after 3 weeks
4

Visuo-spatial abilities

Rey Figure - copy: test score range from 0 to 36, higher scores indicate better performance

Time frame
baseline and after 3 weeks

Secondary outcomes

1

biomarkers of neurodegeneration

blood concentration (pg/ml)

Time frame
baseline and after 3 weeks
2

psychosocial wellbeing and satisfaction

Psychological General Well-Being Index (i.e., test scores)

Time frame
baseline and after 3 weeks
3

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.

Time frame
baseline and after 3 weeks

Other outcomes

Sponsors and contacts

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