Italian PheNotypes Obstructive Sleep Apnea Study
- Conditions
- Sleep Apnea
- Registration Number
- NCT06872242
- Lead Sponsor
- Istituto Auxologico Italiano
- Brief Summary
Obstructive Sleep Apnea (OSA) is the most common sleep-related breathing disorder, representing a major socioeconomic burden on healthcare systems worldwide. Studies performed in Europe in the last twenty years showed a very high prevalence and highlighted that the severity of untreated OSA worsens over time. OSA is associated also with an increased risk to develop cardiovascular, cerebrovascular and metabolic diseases. Finally, recent studies reported a very high mortality in untreated OSA patients, including those with mild severity.
Data on European population have been obtained by the "ESADA group" (European Sleep Apnea Database) , a consortium of 25 sleep center across Europe that includes three Italian Research Hospitals. The ESADA showed significant differences between European geographical macrozones in terms of symptoms and complications. However, no data are available for the Italian population in terms of prevalence, clinical presentation and comorbidities.
The present project aims to overcome this limitation by obtaining a more defined picture of OSA in Italy. A cohort study was designed in collaboration with the Sleep Centers endorsed by the Italian Scientific Society of Sleep Medicine (AIMS).
Aims of the present project are to:
1. Assess the distribution different physiological (endotypes) and clinical patterns (phenotypes) of OSA in Italian patients
2. Analyze the association between OSA and co-morbidities
3. implementation of an "Italian database" for long-term follow-up studies.
Methods
* Clinical, sleep study and treatment data will be collected for each patient. A clinical questionnaire will be developed in order to standardize the clinical data collection; to this end a feasibility study will be performed on 100 patients (25 pts for Coordinator/HUB center).
* Excessive daytime Sleepiness, Neurocognitive, anxiety/depression screening
* A web-based data collection platform will be designed to store pseudo-anonymized individual data.
OUTCOMES
1. Distribution of OSA severity in Italy according to the different classification methods
2. Definition of metabolic, cerebro- and cardiovascular risk factors prevalence associated with OSA in Italian Population
3. Distribution of different physiological and clinical patterns and their association with co-morbidities
4. Definition of a screening/case finding questionnaire for Italian Population
5. Definition of an ongoing cohort of patients that will be followed-up
6. Implementation of an OSA registry that will be shared with Italian Health System or Agencies to designed preventive or early diagnosis interventions to reduce the health impact of the disease.
- Detailed Description
Obstructive Sleep Apnea (OSA) is the most common sleep-related breathing disorder, representing a major socioeconomic burden on healthcare systems worldwide. Studies performed in Europe in the last twenty years showed a very high prevalence and highlighted that the severity of untreated OSA worsens over time. OSA is associated also with an increased risk to develop cardiovascular, cerebrovascular and metabolic diseases. Finally, recent studies reported a very high mortality in untreated OSA patients, including those with mild severity.
Data on European population have been obtained by the "ESADA group" (European Sleep Apnea Database), a consortium of 25 sleep center across Europe that includes three Italian Research Hospitals. The ESADA showed significant differences between European geographical macrozones in terms of symptoms and complications. However, no data are available for the Italian population in terms of prevalence, clinical presentation and comorbidities.
The present project aims to overcome this limitation by obtaining a more defined picture of OSA in Italy. A cohort study was designed in collaboration with the Sleep Centers endorsed by the Italian Scientific Society of Sleep Medicine (AIMS).
Aims of the present project are to:
1. Assess the distribution different physiological (endotypes) and clinical patterns (phenotypes) of OSA in Italian patients
2. Analyze the association between OSA and co-morbidities by taking into account the phenotypes already described in the literature, i.e., ESADA, Icelandic Sleep Cohort, and BAVENO classification;
3. implementation of an "Italian database" for long-term follow-up studies. The project will set an HUB and SPOKE organization that include 4 leading research Sleep Center distributed over the Italian territory in collaboration with the Italian Scientific Society of Sleep Medicine (AIMS) network. AIMS is member of the European Federation of National Sleep Society as well as part of World Sleep Association.
Methods
* Clinical, sleep study and treatment data will be collected for each patient. A clinical questionnaire will be developed in order to standardize the clinical data collection; to this end a feasibility study will be performed on 100 patients (25 pts for Coordinator/HUB center). Additional clinical tests will include: EKG, Spirometry, ABPM, standard blood chemistry, CPR, TSH reflex, glycemic control assesment, Vitamin D and B12.
* Excessive daytime Sleepiness, Neurocognitive, anxiety/depression screening will be performed by means of ESS, MOCA and HADS, respectively
* A web-based data collection platform will be designed to store pseudo-anonymized individual data.
OUTCOMES
1. Distribution of OSA severity in Italy according to the different classification methods (AHI based; hypoxic burden; Icelandic Sleep Cohort, ESADA and BAVENO method)
2. Definition of metabolic, cerebro- and cardiovascular risk factors prevalence associated with OSA in Italian Population
3. Distribution of different physiological and clinical patterns and their association with co-morbidities; analysis of differences with other populations.
4. Definition of a screening/case finding questionnaire for Italian Population
5. Definition of an ongoing cohort of patients that will be followed-up
6. Implementation of an OSA registry that will be shared with Italian Health System or Agencies to designed preventive or early diagnosis interventions to reduce the health impact of the disease.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 5000
- Suspected Obstructive Sleep Apnea
- Age 18 years or older
- Unstable psychiatric disease
- Limited life expectancy due to illness unrelated to sleep apnoea or other medical conditions which may interfere with the study protocol in the opinion of the investigator
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Apnea-Hypopnea Index At enrollment Apnea-Hypopnea Index as determined by Polysomnography
Oxygen saturation At enrollment Oxygen saturation as determined by Polysomnography
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (30)
ASP Cosenza- PO Beato Angelico
🇮🇹Acri, Italy
Azienda Ospedaliero-Universitaria di Parma
🇮🇹Parma, Italy
IRCCS Fondazione Mondino
🇮🇹Pavia, Italy
Istituti Clinici Scientifici Maugeri
🇮🇹Pavia, Italy
Casa di Cura "Villa Serena"
🇮🇹Pescara, Italy
Azienda Ospedaliero-Universitaria Pisana
🇮🇹Pisa, Italy
IRCCS Neuromed - Istituto Neurologico Mediterraneo
🇮🇹Pozzilli, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
🇮🇹Roma, Italy
Policlinico Tor Vergata
🇮🇹Roma, Italy
AOU Città della Salute e della Scienza di Torino - SC Otorinolaringoiatria
🇮🇹Torino, Italy
USL Umbria1 - Ambulatorio disturbi del sonno
🇮🇹Umbertide, Italy
AOU delle Marche
🇮🇹Ancona, Italy
AOU Policlinico di Bari
🇮🇹Bari, Italy
ASST Papa Giovanni XXIII
🇮🇹Bergamo, Italy
Casa di cura San Francesco-Istituto Madre Rubatto
🇮🇹Bergamo, Italy
AUSL Bologna - Clinica odontoiatrica DIBINEM
🇮🇹Bologna, Italy
AUSL Bologna - Ospedale di Bellaria
🇮🇹Bologna, Italy
AOU Cagliari - Centro interdipartimentale dei disturbi del sonno
🇮🇹Cagliari, Italy
AOU Rodolico-S. Marco
🇮🇹Catania, Italy
ASP Cosenza- P.O. di Rossano
🇮🇹Corigliano-Rossano, Italy
Distretto Sanitario Cosenza- Savuto- Ambulatorio di Medicina del Sonno
🇮🇹Cosenza, Italy
AOU Ospedali Riuniti di Foggia
🇮🇹Foggia, Italy
Opera Don Uva Universo Salute
🇮🇹Foggia, Italy
IRCCS Ospedale Policlinico San Martino
🇮🇹Genova, Italy
Ospedale Carlo Urbani
🇮🇹Jesi, Italy
IRCCS Istituto Neurologico "Carlo Besta"
🇮🇹Milano, Italy
Istituto Auxologico Italiano
🇮🇹Milano, Italy
Ospedale San Paolo
🇮🇹Milano, Italy
AO dei Colli - PO Monaldi
🇮🇹Napoli, Italy
Ospedali Riuniti Villa Sofia Cervello
🇮🇹Palermo, Italy