Clinical trial NCT06872242: Italian PheNotypes Obstructive Sleep Apnea Study
Official title: Italian PheNotypes Obstructive Sleep Apnea Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sleep Apnea
Keywords: Sleep apnea
Phenotypes
Diagnosis
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2025-03-12
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients referred to the Italian Sleep Centres because of suspected Obstructive Sleep Apnea

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.

Eligibility criteria: Inclusion Criteria:

* Suspected Obstructive Sleep Apnea
* Age 18 years or older

Exclusion Criteria:

* 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

Primary outcomes:
measure: Apnea-Hypopnea Index
timeFrame: At enrollment
measure: Oxygen saturation
timeFrame: At enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Acri
country: Italy
facility: ASP Cosenza- PO Beato Angelico
city: Ancona
country: Italy
facility: AOU delle Marche
city: Bari
country: Italy
facility: AOU Policlinico di Bari
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII
city: Bergamo
country: Italy
facility: Casa di cura San Francesco-Istituto Madre Rubatto
city: Bologna
country: Italy
facility: AUSL Bologna - Clinica odontoiatrica DIBINEM
city: Bologna
country: Italy
facility: AUSL Bologna - Ospedale di Bellaria
city: Cagliari
country: Italy
facility: AOU Cagliari - Centro interdipartimentale dei disturbi del sonno
city: Catania
country: Italy
facility: AOU Rodolico-S. Marco
city: Corigliano-Rossano
country: Italy
facility: ASP Cosenza- P.O. di Rossano
city: Cosenza
country: Italy
facility: Distretto Sanitario Cosenza- Savuto- Ambulatorio di Medicina del Sonno
city: Foggia
country: Italy
facility: AOU Ospedali Riuniti di Foggia
city: Foggia
country: Italy
facility: Opera Don Uva Universo Salute
city: Genova
country: Italy
facility: IRCCS Ospedale Policlinico San Martino
city: Jesi
country: Italy
facility: Ospedale Carlo Urbani
city: Milano
country: Italy
facility: IRCCS Istituto Neurologico "Carlo Besta"
city: Milano
country: Italy
facility: Istituto Auxologico Italiano
city: Milano
country: Italy
facility: Ospedale San Paolo
city: Napoli
country: Italy
facility: AO dei Colli - PO Monaldi
city: Palermo
country: Italy
facility: Ospedali Riuniti Villa Sofia Cervello
city: Parma
country: Italy
facility: Azienda Ospedaliero-Universitaria di Parma
city: Pavia
country: Italy
facility: IRCCS Fondazione Mondino
city: Pavia
country: Italy
facility: Istituti Clinici Scientifici Maugeri
city: Pescara
country: Italy
facility: Casa di Cura "Villa Serena"
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana
city: Pozzilli
country: Italy
facility: IRCCS Neuromed - Istituto Neurologico Mediterraneo
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
city: Roma
country: Italy
facility: Policlinico Tor Vergata
city: Torino
country: Italy
facility: AOU Città della Salute e della Scienza di Torino - SC Otorinolaringoiatria
city: Umbertide
country: Italy
facility: USL Umbria1 - Ambulatorio disturbi del sonno
Study officials:
References: