PASHOS Project: Advanced Platform for Sleep Apnea Syndrome Assessment
1 other identifier
observational
198
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 27, 2015
CompletedFirst Posted
Study publicly available on registry
October 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedMarch 5, 2019
March 1, 2019
3.6 years
October 27, 2015
March 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Apnea/Hypopnea Index
At primary healthcare
At baseline
Apnea/Hypopnea Index
At Sleep Lab Unit
At 3 months
Secondary Outcomes (5)
Cardiovascular risk factors
At baseline
History of cardiovascular or cerebrovascular disease
At baseline
Lung function tests
At baseline
Self-perceived sleepiness. Epworth Test
At baseline
Self-perceived sleepiness. Epworth Test
At 3 months
Eligibility Criteria
Patients visited at Primary Care consultations will be included according to a randomization schedule to reach the necessary sample.
You may qualify if:
- Patients between 18 to 75 years.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Barcelona, 08025, Spain
Related Publications (2)
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: 35033055DERIVEDPenacoba 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: 32279702DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2015
First Posted
October 30, 2015
Study Start
March 1, 2015
Primary Completion
October 1, 2018
Study Completion
October 1, 2018
Last Updated
March 5, 2019
Record last verified: 2019-03