PASHOS Project: Advanced Platform for Sleep Apnea Syndrome Assessment

Completed

• Conditions: Sleep Apnea Syndrome

• Registration Number: NCT02591979
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-10-27
• Study First Submitted QC: 2015-10-29
• Study First Posted: 2015-10-30
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-03
• Last Update Posted: 2019-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Apnea/Hypopnea Index	At 3 months	At Sleep Lab Unit

Secondary Outcome Measures

Name	Time	Method
Lung function tests	At baseline
History of cardiovascular or cerebrovascular disease	At baseline
Cardiovascular risk factors	At baseline
Self-perceived sleepiness. Epworth Test	At 3 months	At Sleep lab unit

Trial Locations

Locations (1)

Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain