Italian PheNotypes Obstructive Sleep Apnea Study
IPNOS
1 other identifier
observational
5,000
1 country
30
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:
- 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
- Distribution of OSA severity in Italy according to the different classification methods
- Definition of metabolic, cerebro- and cardiovascular risk factors prevalence associated with OSA in Italian Population
- Distribution of different physiological and clinical patterns and their association with co-morbidities
- Definition of a screening/case finding questionnaire for Italian Population
- Definition of an ongoing cohort of patients that will be followed-up
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2024
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2024
CompletedFirst Submitted
Initial submission to the registry
February 28, 2025
CompletedFirst Posted
Study publicly available on registry
March 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 23, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 23, 2025
CompletedMarch 12, 2025
March 1, 2025
1.4 years
February 28, 2025
March 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Apnea-Hypopnea Index
Apnea-Hypopnea Index as determined by Polysomnography
At enrollment
Oxygen saturation
Oxygen saturation as determined by Polysomnography
At enrollment
Study Arms (1)
Patients with suspected obstructive sleep apnea (OSA)
Patients referred to the Italian Sleep Centres because of suspected OSA
Interventions
Polysomnography after enrollment for suspected obstructive sleep apnea
Eligibility Criteria
Adult patients referred to the Italian Sleep Centres because of suspected Obstructive Sleep Apnea
You may qualify if:
- Suspected Obstructive Sleep Apnea
- Age 18 years or older
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
ASP Cosenza- PO Beato Angelico
Acri, 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
Iesi, Italy
IRCCS Istituto Neurologico "Carlo Besta"
Milan, Italy
Istituto Auxologico Italiano
Milan, Italy
Ospedale San Paolo
Milan, Italy
AO dei Colli - PO Monaldi
Napoli, Italy
Ospedali Riuniti Villa Sofia Cervello
Palermo, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2025
First Posted
March 12, 2025
Study Start
June 1, 2024
Primary Completion
October 23, 2025
Study Completion
October 23, 2025
Last Updated
March 12, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share