Actively Recruiting
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
Led by IRCCS San Raffaele · Updated on 2024-11-07
500
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Obstructive Sleep Apnea Syndrome (OSAS) is a common sleep-related breathing disorder affecting 9-38% of the general population, more often men and increasing with age. It causes symptoms such as snoring, excessive daytime sleepiness, fragmented sleep, frequent awakenings often linked to nocturia, and morning headaches. These disruptions can impair cognitive functions like attention, memory, and executive skills over time, and OSAS is connected to a higher risk of neurodegenerative diseases such as Mild Cognitive Impairment and Alzheimer's Dementia. Researchers aim to better understand OSAS's impact on cognitive decline and identify patients at higher risk for these diseases. This observational study is conducted by IRCCS San Raffaele Hospital's Neurology - Sleep Disorders Center in Milan. It focuses on patients diagnosed with OSAS according to international standards. The study involves monitoring patients over a period of up to three years to collect detailed clinical and neuroimaging data, aiming to identify phenotypes at higher risk for neurodegenerative progression. No experimental treatments are given, as this is an observational model to improve early diagnosis and therapy monitoring. Participants will be followed regularly to gather information on their clinical signs, symptoms, treatment outcomes, and cognitive status. Data collected will support research, improve resource allocation, and optimize care for patients and families. The primary outcome is to characterize patient profiles at higher risk of progressing to neurodegenerative diseases during the three-year follow-up. This study may advance scientific knowledge and public health strategies related to OSAS management and its broader effects.
CONDITIONS
Brief Title
Multidisciplinary Network OSA Code (Obstructive Apnea Syndrome): Digital Operative Model in Public Health for an Early Diagnosis and Therapy Monitoring
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with obstructive sleep apnea syndrome according to the American Academy of Sleep Society International Classification of Sleep Disorders, third edition (ICSD-3)
- Male and female patients
- Age over 18 years
You will not qualify if you...
- Unable to provide signed informed consent
- Refusal to participate or withdrawal of consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants are monitored over time to characterize their profile and risk of neurodegenerative diseases.
Periodic visits during the 3-year follow-up
Trial Site Locations
Total: 1 location
1
IRCCS San Raffaele Hospital - Sleep Disorders Center
Milan, Italy, Italy, 20127
Actively Recruiting
Research Team
L
Luigi Ferini Strambi, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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