Sleep Apnea SyndromeNCT02591979
PASHOS Project: Advanced Platform for Sleep Apnea Syndrome Assessment
An observational study of Sleep Apnea Syndrome, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sleep Apnea Syndrome
- How many people
- 198 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2015to Oct 2018
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients visited at Primary Care consultations will be included according to a randomization schedule to reach the necessary sample.
Who may be able to join
- Patients between 18 to 75 years.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
About this study
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
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
- Sleep Apnea Syndrome
- Keywords
- Sleep Apnea Syndrome, Primary Health Care
- Medical subject headings
- Sleep Apnea Syndromes
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea/Hypopnea Index
At primary healthcare
Measured: At baseline
Apnea/Hypopnea Index
At Sleep Lab Unit
Measured: At 3 months
Secondary outcomes (5)
Cardiovascular risk factors
Measured: At baseline
History of cardiovascular or cerebrovascular disease
Measured: At baseline
Lung function tests
Measured: At baseline
Self-perceived sleepiness. Epworth Test
At primary healthcare
Measured: At baseline
Self-perceived sleepiness. Epworth Test
At Sleep lab unit
Measured: At 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startMar 2015
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea SyndromeStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 198 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591979
- Sponsor's protocol ID
- IIBSP-PAS-2013-151
- Status last verified
- Mar 2019
- First submitted
- 27 Oct 2015
- Last updated
- 5 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35033055Penacoba 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.
PubMed 32279702
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02591979
- Acronym / sponsor ID
- IIBSP-PAS-2013-151
- Conditions
- Sleep Apnea Syndrome
- Keywords
- Sleep Apnea Syndrome, Primary Health Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 30 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients visited at Primary Care consultations will be included according to a randomization schedule to reach the necessary sample.
Key inclusion criteria (1 listed)
- Patients between 18 to 75 years.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Apnea/Hypopnea Index
Time frame: At baseline
At primary healthcare
Apnea/Hypopnea Index
Time frame: At 3 months
At Sleep Lab Unit
5 secondary outcomes
Cardiovascular risk factors
Time frame: At baseline
History of cardiovascular or cerebrovascular disease
Time frame: At baseline
Lung function tests
Time frame: At baseline
Self-perceived sleepiness. Epworth Test
Time frame: At baseline
Self-perceived sleepiness. Epworth Test
Time frame: At 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Derived from this study: PubMed 35033055Penacoba 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.
- Derived from this study: PubMed 32279702Penacoba 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea Syndrome, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea/Hypopnea Index (time frame: At baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02591979, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.