NCT06677580: DOMOSA

Multidisciplinary Network OSA Code (Obstructive Apnea Syndrome): Digital Operative Model in Public Health for an Early Diagnosis and Therapy Monitoring

Recruiting now Last updated 7 November 2024

What this trial tests

trial in OSA - Obstructive Sleep Apnea in 500 participants. Currently enrolling.

Timeline

13 March 2024

Primary endpoint
1 March 2029

1 December 2029

Quick facts

Lead sponsor	IRCCS San Raffaele
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	500
Start date	13 March 2024
Primary completion	1 March 2029
Estimated completion	1 December 2029
Sites	1 location across Italy

Conditions studied

• OSA - Obstructive Sleep Apnea — all drugs for OSA - Obstructive Sleep Apnea →

Sponsor

IRCCS San Raffaele — full company profile →

Who can join

18 and older, any sex, with OSA - Obstructive Sleep Apnea. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.