OSA - Obstructive Sleep ApneaDOMOSANCT06677580
Multidisciplinary Network OSA Code (Obstructive Apnea Syndrome): Digital Operative Model in Public Health for an Early Diagnosis and Therapy Monitoring
An observational study of OSA - Obstructive Sleep Apnea, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- OSA - Obstructive Sleep Apnea
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 13 Mar 2024to 1 Dec 2029
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patientswith obstructive sleep apnea syndrome, male and female, with age > 18 years
Who may be able to join
- 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
Who cannot join
- Unable of giving signed informed consent
- Refuse to participate or withdrawal the consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS San Raffaele Hospital - Sleep Disorders Center
Milan, Italy, 20127
Luigi Ferini Strambi, MD, +390226433363, ferinistrambi.luigi@hsr.it
About this study
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
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.
Read more
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.
- Conditions
- OSA - Obstructive Sleep Apnea
- Medical subject headings
- Sleep Apnea, Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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, particularly Alzheimer's Dementia and Mild Cognitive Impairment
Measured: From enrollment to the end of 3 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start13 Mar 2024
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OSA - Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luigi Ferini Strambi, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677580
- Sponsor's protocol ID
- CET 94-2023
- Acronym
- DOMOSA
- Status last verified
- Nov 2024
- First submitted
- 5 Nov 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06677580
- Acronym / sponsor ID
- DOMOSA / CET 94-2023
- Conditions
- OSA - Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 13 Mar 2024 (actual)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 6 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patientswith obstructive sleep apnea syndrome, male and female, with age > 18 years
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Unable of giving signed informed consent
- Refuse to participate or withdrawal the consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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, particularly Alzheimer's Dementia and Mild Cognitive Impairment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of OSA - Obstructive Sleep Apnea, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luigi Ferini Strambi, MD (+390226433363, ferinistrambi.luigi@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.