Loading clinical trials...
Loading clinical trials...
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
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
IRCCS San Raffaele Hospital - Sleep Disorders Center
Milan, Italy, Italy
Start Date
March 13, 2024
Primary Completion Date
March 1, 2029
Completion Date
December 1, 2029
Last Updated
November 7, 2024
500
ESTIMATED participants
Lead Sponsor
IRCCS San Raffaele
NCT06722755
NCT07387094
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions