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Taking people in ItalyNo phase

Italian PheNotypes Obstructive Sleep Apnea Study

Key facts

Who runs it
Istituto Auxologico Italiano
Where
Acri, Ancona, Bari, Bergamo, Bologna, Cagliari, Catania, Corigliano-Rossano, Cosenza, Foggia, Genova, Iesi, Milan, Naples, Palermo, Parma, Pavia, Pescara, Pisa, Pozzilli, Roma, Torino, and Umbertide, ItalySee the 30 sites
Trial code
Status
Recruiting
People taking part
5,000 people, planned
Started
1 Jun 2024
Planned end
23 Oct 2025
Type of study
Observational
Treatments tested
  • Polysomnography
Record updated
12 March 2025

Who can take part

Age
18 years and older
Sex
Women and men

The registry criteria, word for word

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Who can take part

  • Suspected Obstructive Sleep Apnea
  • Age 18 years or older

Who cannot take part

  • 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

Where in Italy

  • ASP Cosenza- PO Beato AngelicoAcri, ItalyContact: Maria FerraroTaking people
  • AOU delle MarcheAncona, ItalyContact: Antonina ReNot yet recruiting
  • AOU Policlinico di BariBari, ItalyContact: Elisiana CarpagnanoTaking people
  • Asst Papa Giovanni XXIIIBergamo, ItalyContact: Maria Cristina ServalliTaking people
  • Casa di cura San Francesco-Istituto Madre RubattoBergamo, ItalyContact: Anna MicheliTaking people
  • AUSL Bologna - Ospedale di BellariaBologna, ItalyContact: Federica ProviniNot yet recruiting
  • AUSL Bologna - Clinica odontoiatrica DIBINEMBologna, ItalyContact: Carolina Lombardi, PhDNo longer taking part
  • AOU Cagliari - Centro interdipartimentale dei disturbi del sonnoCagliari, ItalyContact: Stefania RedolfiTaking people
  • AOU Rodolico-S. MarcoCatania, ItalyContact: Alberto BianchiNot yet recruiting
  • ASP Cosenza- P.O. di RossanoCorigliano-Rossano, ItalyContact: Miguel Angel PaludiTaking people
  • Distretto Sanitario Cosenza- Savuto- Ambulatorio di Medicina del SonnoCosenza, ItalyContact: Paola Elisa ScarpinoTaking people
  • AOU Ospedali Riuniti di FoggiaFoggia, ItalyContact: Pasquale TondoTaking people
  • Opera Don Uva Universo SaluteFoggia, ItalyContact: Maria Pia Foschino BarbaroTaking people
  • IRCCS Ospedale Policlinico San MartinoGenova, ItalyContact: Dario ArnaldiNot yet recruiting
  • Ospedale Carlo UrbaniIesi, ItalyContact: Alessia ResediNot yet recruiting
  • IRCCS Istituto Neurologico Carlo BestaMilan, ItalyContact: Giuseppe DidatoTaking people
  • Istituto Auxologico ItalianoMilan, ItalyContact: Carolina LombardiTaking people
  • Ospedale San PaoloMilan, ItalyContact: Elena ZambrelliTaking people
  • AO dei Colli - PO MonaldiNaples, ItalyContact: Marialuisa BocchinoNot yet recruiting
  • Ospedali Riuniti Villa Sofia - CervelloPalermo, ItalyContact: Maria Rosaria BonsignoreTaking people
  • Azienda Ospedaliero Universitaria di ParmaParma, ItalyContact: Liborio ParrinoNot yet recruiting
  • IRCCS Fondazione MondinoPavia, ItalyContact: Michele TerzaghiTaking people
  • Istituti Clinici Scientifici MaugeriPavia, ItalyContact: Francesco FanfullaTaking people
  • Casa di Cura "Villa Serena"Pescara, ItalyContact: Biancamaria GuarnieriNot yet recruiting
  • Azienda Ospedaliero Universitaria PisanaPisa, ItalyContact: Enrica BonanniTaking people
  • IRCCS Neuromed - Istituto Neurologico MediterraneoPozzilli, ItalyContact: Andrea RomigiTaking people
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCSRoma, ItalyContact: Valerio BrunettiNot yet recruiting
  • Policlinico Tor VergataRoma, ItalyContact: Claudio LiguoriNot yet recruiting
  • AOU Città della Salute e della Scienza di Torino - SC OtorinolaringoiatriaTorino, ItalyContact: Giuseppe RivaNot yet recruiting
  • USL Umbria1 - Ambulatorio disturbi del sonnoUmbertide, ItalyContact: Chiara BedettiTaking people

About the trial

What the trial wants to find out

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.

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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.

The group in the trial

  • Patients with suspected obstructive sleep apnea (OSA)

    Patients referred to the Italian Sleep Centres because of suspected OSA

    Treatment: Polysomnography

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
12 March 2025