Multidisciplinary Network OSA Code (Obstructive Apnea Syndrome): Digital Operative Model in Public Health for an Early Diagnosis and Therapy Monitoring
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: OSA - Obstructive Sleep Apnea. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Multidisciplinary Network OSA Code (Obstructive Apnea Syndrome): Digital Operative Model in Public Health for an Early Diagnosis and Therapy Monitoring, a Monocentric Observational Prospective Study
Overview
Obstructive Sleep Apnea Syndrome (OSAS) is a sleep related breathing disorder with high epidemiological impact (9-38% of general population), more frequently reported in male gender and increasing with the age. Pathognomonic OSAS symptoms are snoring, excessive daytime sleepiness, sleep fragmentation, awakening during the night often for nocturia and morning headache. The repeated sleep fragmentation due to numerous awakenings (the patient is often unaware of this) can impair higher cognitive functions over the time and negatively impact the quality of life, If timely untreated. Among the most frequently impaired cognitive functions detected in OSAS patients, there are attention, concentration, amnestic and executive domains. While these impairments are well documented in literature, the pathogenetic mechanisms underlying cognitive impairment are not yet defined. To date, the most widely accepted pathophysiological hypotheses are two: i) intermittent hypoxia (frequent brain awakenings); ii) sleep fragmentation. Moreover solid evidence report that, there is a strict correlation between OSAS and neurodegenerative diseases, such as Mild Cognitive Impairment (MCI) and Alzheimer's Dementia (AD). Indeed, OSAS might act as a trigger, accelerating the accumulation of harmful proteins in the brain, in particular beta-amyloid and tau protein. The first-line treatment for OSAS is Continuous Positive Airway Pressure (CPAP). Of note is the effect of CPAP treatment on higher cognitive function in OSAS patients. Not all OSAS' patients, however, develop MCI/AD over time. For this reason, to identify the OSA phenotype (both clinical and neuroimaging) at higher risk of phenoconversion represents an important challenge for neuropsychologists and neurologists. The interest on OSAS is not purely scientific, but also economic, whit important repercussions on the intake and costs of hospital and home management of OSAS' patients. In conclusion, OSAS is a syndrome needing great attention for several reasons: i) from a scientific point of view, it is important to identify for the risk of phenoconversion to highly disabling neurodegenerative diseases; ii) from an economic-welfare point of view, to reduce costs that still burden NHS. In summary, the study may have an important impact on Public Health, considering the various aspects related to the taking care and management of OSAS' patients: 1) To know in details, the syndrome epidemiology and on this basis provide for the corresponding commitment of resources, suitable for implementing the support activities for both patients and families; 2) To have major information on the real prevalence of clinical signs and symptoms, to support and optimize the care efforts of physicians; 3) To assess the prognostic factors and outcomes of the treatment; 4) On the basis of the data collected in the platform, to have the possibility for support research. OSAS-platform could represent one of the most effective methods to improve scientific, clinical and therapeutical knowledge on OSAS-pathology.
Primary outcome measures
- To characterize the profile of patients with obstructive sleep apnea syndrome (afferent to IRCCS San Raffaele Hospital, UO Neurology - Sleep Disorders Center, Milan) at higher risk of conversion to neurodegenerative diseases [Time frame: From enrollment to the end of 3 years of follow-up]
Eligibility criteria
Inclusion criteria
- patients with obstructive sleep apnea syndrome (Diagnosis according to American Academy of Sleep Society International Classification of Sleep Disorders, third edition (ICSD-3))
- male and female
- age > 18 years
Exclusion criteria
- Unable of giving signed informed consent
- Refuse to participate or withdrawal the consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS San Raffaele Hospital - Sleep Disorders Center — Milan
Identifiers
NCT: NCT06677580 · CET 94-2023