## Protocol Section
### Identification Module
**NCT ID:** NCT02591979

**Brief Title:** PASHOS Project: Advanced Platform for Sleep Apnea Syndrome Assessment

**Official Title:** PASHOS Project: Advanced Platform for Sleep Apnea Syndrome Assessment. A Multi-Centre Study to Validate a Sleep Apnea Screening Model in Primary Health Care

#### Organization Study ID Info
**ID:** IIBSP-PAS-2013-151
#### Organization
**Class:** OTHER
**Full Name:** Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
### Status Module
#### Completion Date
**Date:** 2018-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-03-05

**Type:** ACTUAL

**Last Update Submit Date:** 2019-03-03

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-10

**Type:** ACTUAL

#### Start Date
**Date:** 2015-03

**Status Verified Date:** 2019-03

#### Study First Post Date
**Date:** 2015-10-30
**Type:** ESTIMATED
**Study First Submit Date:** 2015-10-27
**Study First Submit QC Date:** 2015-10-29
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to develop and validate a work-model in Primary Health Care for identifying patients with Sleep Apnea Syndrome, based on clinical variables and an ambulatory monitoring study.

### Conditions Module

**Conditions:**

- Sleep Apnea Syndrome

**Keywords:**

- Sleep Apnea Syndrome

- Primary Health Care

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 198

**Type:** ACTUAL

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 3 Months

### Outcomes Module

#### Primary Outcomes

**Description:** At primary healthcare

**Measure:** Apnea/Hypopnea Index

**Time Frame:** At baseline

**Description:** At Sleep Lab Unit

**Measure:** Apnea/Hypopnea Index

**Time Frame:** At 3 months

#### Secondary Outcomes

**Measure:** Cardiovascular risk factors

**Time Frame:** At baseline

**Measure:** History of cardiovascular or cerebrovascular disease

**Time Frame:** At baseline

**Measure:** Lung function tests

**Time Frame:** At baseline

**Description:** At primary healthcare

**Measure:** Self-perceived sleepiness. Epworth Test

**Time Frame:** At baseline

**Description:** At Sleep lab unit

**Measure:** Self-perceived sleepiness. Epworth Test

**Time Frame:** At 3 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients between 18 to 75 years.

Exclusion Criteria:

* Cognitive impairment or psycho-physical deterioration that impede to perform ambulatory monitoring study.
* Worsened or unstable cardiovascular or cerebrovascular disease.
* Chronic insomnia (\<5h sleep / day).
* Relevant respiratory comorbidity that could interfere with arterial saturation measurements, as moderate to severe chronic obstructive pulmonary disease.
* Neuromuscular disease.
* Refusal to participate in the study.

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients visited at Primary Care consultations will be included according to a randomization schedule to reach the necessary sample.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Barcelona

**Country:** Spain

**Facility:** Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

**Zip:** 08025

### References Module

#### References

**Citation:** Penacoba P, Llauger MA, Fortuna AM, Flor X, Sampol G, Pedro-Pijoan AM, Grau N, Santiveri C, Juvanteny J, Aoiz JI, Bayo J, Lloberes P, Mayos M; PASHOS Working Group. A new tool to screen patients with severe obstructive sleep apnea in the primary care setting: a prospective multicenter study. BMC Pulm Med. 2022 Jan 15;22(1):38. doi: 10.1186/s12890-022-01827-0.

**PMID:** 35033055

**Citation:** Penacoba P, Llauger MA, Fortuna AM, Flor X, Sampol G, Pedro Pijoan AM, Grau N, Santiveri C, Juvanteny J, Aoiz JI, Bayo J, Lloberes P, Mayos M; PASHOS Working Group. Primary care and sleep unit agreement in management decisions for sleep apnea: a prospective study in Spain. J Clin Sleep Med. 2020 Sep 15;16(9):1579-1589. doi: 10.5664/jcsm.8492.

**PMID:** 32279702

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004194

- Term: Disease

- ID: D000010335

- Term: Pathologic Processes

- ID: D000012120

- Term: Respiration Disorders

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000012818

- Term: Signs and Symptoms, Respiratory

- ID: D000020919

- Term: Sleep Disorders, Intrinsic

- ID: D000020920

- Term: Dyssomnias

- ID: D000012893

- Term: Sleep Wake Disorders

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: HIGH

- As Found: Syndrome

- ID: M4361

- Name: Apnea

- Relevance: HIGH

- As Found: Apnea

- ID: M15694

- Name: Sleep Apnea Syndromes

- Relevance: HIGH

- As Found: Sleep Apnea Syndrome

- ID: M14957

- Name: Respiration Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15623

- Name: Signs and Symptoms, Respiratory

- Relevance: LOW

- As Found: Unknown

- ID: M22242

- Name: Parasomnias

- Relevance: LOW

- As Found: Unknown

- ID: M22654

- Name: Sleep Disorders, Intrinsic

- Relevance: LOW

- As Found: Unknown

- ID: M22655

- Name: Dyssomnias

- Relevance: LOW

- As Found: Unknown

- ID: M15696

- Name: Sleep Wake Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001049

- Term: Apnea

- ID: D000012891

- Term: Sleep Apnea Syndromes

- ID: D000013577

- Term: Syndrome

### Misc Info Module

- Version Holder: 2024-05-24
