Italian PheNotypes Obstructive Sleep Apnea Study (IPNOS)

Istituto Auxologico Italiano

Status: Enrolling

Conditions: Sleep Apnea

Treatments: Diagnostic Test: Polysomnography

Study type: Observational

Funder types: Other

Identifiers

NCT06872242

09M205

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

5,000 participants in 1 patient group

Patients with suspected obstructive sleep apnea (OSA)

Description:

Patients referred to the Italian Sleep Centres because of suspected OSA

Treatment:

Diagnostic Test: Polysomnography