Atrial FibrillationPROSERPin-AFNCT05784077
PRevalence of Obstructive Sleep apnoEa and Reduction of Promoters in AF
An observational study of Atrial Fibrillation and Osa Syndrome, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial summary
This study aims to identify how many patients who have atrial fibrillation, also have sleep apnoea. This is important because sleep apnoea can be a trigger to atrial fibrillation and it can be corrected with a simple intervention. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation, Osa Syndrome
- What is being tested?
- Polysomnography and Lifestyle counselling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 343 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2020to 31 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- Adult, Older adult
Study population: patients between 18 and 75 years of age, male and female, who come to the study centre between January 2019 and January 2023 with a diagnosis of atrial fibrillation and a recurrence (or first episode) in the previous year and who can undergo polysomnography
Who may be able to join
- 1 episode of atrial fibrillation in the previous year
- BMI > o = 27Kg/m2
- AHI >30 o con 15<AHI<30 associated with other symptoms (sleeplessness, uncontrolled hypertension and cerebral events)
Who cannot join
- Ejection Fraction <50%
- HFpEF not related to atrial fibrillation.
- coronary artery disease
- valvular cardiomyopathy
- patient already in treatment for sleep apnoea
- hyperthyroidism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalenza Delle Apnee Notturne e Riduzione Dei Fattori Promotori Nella Fibrillazione Atriale
This study aims to identify how many patients who have atrial fibrillation, also have sleep apnoea. This is important because sleep apnoea can be a trigger to atrial fibrillation and it can be corrected with a simple intervention. Therefore it is important to understand its prevalence (how many patients with atrial fibrillation are affected by it). Also, obesity and sleep disorders are often associated, therefore the evolution of atrial fibrillation is studied in patients who also have obesity and have lost weight compared with patients who did not loose any weight or are not obese. As medications or therapy are not changed, this is an observational study.
- Conditions
- Atrial Fibrillation, Osa Syndrome
- Being tested
- Polysomnography, Lifestyle counselling
- Medical subject headings
- Atrial Fibrillation, Carnevale syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolysomnographyDiagnostic test
Study of the sleep pattern
Lifestyle counsellingBehavioural
Weight loss counselling
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in prevalence of obstructive sleep apnoea in patients with atrial fibrillation
Change in prevalence of obstructive sleep apnoea from baseline to 3 years
Measured: Baseline and at 3, 6, 12, 24 and 36 months
Percentage of men and women with obstructive sleep apnoea in patients with atrial fibrillation
Percentage of men and women with obstructive sleep apnoea in patients with atrial fibrillation
Measured: Baseline
Secondary outcomes (3)
Change in body weight
Change in body weight from baseline to 3 years
Measured: Baseline and at 3, 6, 12, 24 and 36 months
Change in incidence of atrial fibrillation recurrencies
Change in incidence of atrial fibrillation recurrencies from baseline to 3 years
Measured: Baseline and at 3, 6, 12, 24 and 36 months
Change in quality of life
Change in quality of life from baseline to 3 years
Measured: Baseline and at 3, 6, 12, 24 and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start1 Jan 2020
- Primary completion31 Dec 2022
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe 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
- Prospective
- Enrolment
- 343 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05784077
- Sponsor's protocol ID
- 09C020
- Acronym
- PROSERPin-AF
- Status last verified
- Mar 2023
- First submitted
- 13 Mar 2023
- Last updated
- 24 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalenza Delle Apnee Notturne e Riduzione Dei Fattori Promotori Nella Fibrillazione Atriale
- ClinicalTrials.gov ID
- NCT05784077
- Acronym / sponsor ID
- PROSERPin-AF / 09C020
- Conditions
- Atrial Fibrillation, Osa Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 343 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 24 Mar 2023 (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.
This study aims to identify how many patients who have atrial fibrillation, also have sleep apnoea. This is important because sleep apnoea can be a trigger to atrial fibrillation and it can be corrected with a simple intervention. Therefore it is important to understand its prevalence (how many patients with atrial fibrillation are affected by it). Also, obesity and sleep disorders are often associated, therefore the evolution of atrial fibrillation is studied in patients who also have obesity and have lost weight compared with patients who did not loose any weight or are not obese. As medications or therapy are not changed, this is an observational study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients between 18 and 75 years of age, male and female, who come to the study centre between January 2019 and January 2023 with a diagnosis of atrial fibrillation and a recurrence (or first episode) in the previous year and who can undergo polysomnography
Key inclusion criteria (3 listed)
- 1 episode of atrial fibrillation in the previous year
- BMI > o = 27Kg/m2
- AHI >30 o con 15<AHI<30 associated with other symptoms (sleeplessness, uncontrolled hypertension and cerebral events)
Key exclusion criteria (6 listed)
- Ejection Fraction <50%
- HFpEF not related to atrial fibrillation.
- coronary artery disease
- valvular cardiomyopathy
- patient already in treatment for sleep apnoea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PolysomnographyStudy of the sleep pattern | Diagnostic test | – |
| Lifestyle counsellingWeight loss counselling | Behavioural | – |
Primary outcome
Change in prevalence of obstructive sleep apnoea in patients with atrial fibrillation
Time frame: Baseline and at 3, 6, 12, 24 and 36 months
Change in prevalence of obstructive sleep apnoea from baseline to 3 years
Percentage of men and women with obstructive sleep apnoea in patients with atrial fibrillation
Time frame: Baseline
Percentage of men and women with obstructive sleep apnoea in patients with atrial fibrillation
3 secondary outcomes
Change in body weight
Time frame: Baseline and at 3, 6, 12, 24 and 36 months
Change in incidence of atrial fibrillation recurrencies
Time frame: Baseline and at 3, 6, 12, 24 and 36 months
Change in quality of life
Time frame: Baseline and at 3, 6, 12, 24 and 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Atrial Fibrillation and Osa Syndrome, run by Istituto Auxologico Italiano 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 6 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: status not confirmed, as of the sponsor's last update on 24 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in prevalence of obstructive sleep apnoea in patients with atrial fibrillation (time frame: Baseline and at 3, 6, 12, 24 and 36 months). The study lists 2 primary outcomes in all. 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 24 Mar 2023.