Italian PheNotypes Obstructive Sleep Apnea Study

Status: Recruiting
Location: See all (30) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:

• Suspected Obstructive Sleep Apnea

• Age 18 years or older

Locations
Other Locations
Italy
ASP Cosenza- PO Beato Angelico
RECRUITING
Acri
AOU delle Marche
NOT_YET_RECRUITING
Ancona
AOU Policlinico di Bari
RECRUITING
Bari
ASST Papa Giovanni XXIII
RECRUITING
Bergamo
Casa di cura San Francesco-Istituto Madre Rubatto
RECRUITING
Bergamo
AUSL Bologna - Clinica odontoiatrica DIBINEM
ACTIVE_NOT_RECRUITING
Bologna
AUSL Bologna - Ospedale di Bellaria
NOT_YET_RECRUITING
Bologna
AOU Cagliari - Centro interdipartimentale dei disturbi del sonno
RECRUITING
Cagliari
AOU Rodolico-S. Marco
NOT_YET_RECRUITING
Catania
ASP Cosenza- P.O. di Rossano
RECRUITING
Corigliano-rossano
Distretto Sanitario Cosenza- Savuto- Ambulatorio di Medicina del Sonno
RECRUITING
Cosenza
AOU Ospedali Riuniti di Foggia
RECRUITING
Foggia
Opera Don Uva Universo Salute
RECRUITING
Foggia
IRCCS Ospedale Policlinico San Martino
NOT_YET_RECRUITING
Genova
Ospedale Carlo Urbani
NOT_YET_RECRUITING
Iesi
IRCCS Istituto Neurologico Carlo Besta
RECRUITING
Milan
Istituto Auxologico Italiano
RECRUITING
Milan
Ospedale San Paolo
RECRUITING
Milan
AO dei Colli - PO Monaldi
NOT_YET_RECRUITING
Napoli
Ospedali Riuniti Villa Sofia Cervello
RECRUITING
Palermo
Azienda Ospedaliero-Universitaria di Parma
NOT_YET_RECRUITING
Parma
IRCCS Fondazione Mondino
RECRUITING
Pavia
Istituti Clinici Scientifici Maugeri
RECRUITING
Pavia
Casa di Cura Villa Serena
NOT_YET_RECRUITING
Pescara
Azienda Ospedaliero-Universitaria Pisana
RECRUITING
Pisa
IRCCS Neuromed - Istituto Neurologico Mediterraneo
RECRUITING
Pozzilli
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
NOT_YET_RECRUITING
Roma
Policlinico Tor Vergata
NOT_YET_RECRUITING
Roma
AOU Città della Salute e della Scienza di Torino - SC Otorinolaringoiatria
NOT_YET_RECRUITING
Torino
USL Umbria1 - Ambulatorio disturbi del sonno
RECRUITING
Umbertide
Contact Information
Primary
Carolina Lombardi, PhD
c.lombardi@auxologico.it
+3902619111
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2025-10-23
Participants
Target number of participants: 5000
Treatments
Patients with suspected obstructive sleep apnea (OSA)
Patients referred to the Italian Sleep Centres because of suspected OSA
Sponsors
Leads: Istituto Auxologico Italiano

This content was sourced from clinicaltrials.gov