PASHOS Project: Advanced Platform for Sleep Apnea Syndrome Assessment

Sleep Apnea Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02591979
• Other study ID #: IIBSP-PAS-2013-151
• Status: Completed
• Start date: March 2015
• Est. completion date: October 2018

Study information

• Verified date: March 2019
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Syndrome

Locations

Country	Name	City	State
Spain	Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea/Hypopnea Index	At primary healthcare	At baseline
Primary	Apnea/Hypopnea Index	At Sleep Lab Unit	At 3 months
Secondary	Cardiovascular risk factors		At baseline
Secondary	History of cardiovascular or cerebrovascular disease		At baseline
Secondary	Lung function tests		At baseline
Secondary	Self-perceived sleepiness. Epworth Test	At primary healthcare	At baseline
Secondary	Self-perceived sleepiness. Epworth Test	At Sleep lab unit	At 3 months