PASHOS Project: Advanced Platform for Sleep Apnea Syndrom... | NCT02591979

Studies
PASHOS Project: Advanced Platform for Sleep Apnea Syndrome Assessment

NCT02591979

Sponsor

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

Status

Completed

Last Update Posted

Mar 5, 2019Actual

Enrollment

198Actual

Phase

Not provided

Conditions

Sleep Apnea Syndrome

Interventions

Not provided

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Oct 2018Actual

Completion Date

Oct 2018Actual

First Submitted Date

Oct 27, 2015

First Submission Date that Met QC Criteria

Oct 29, 2015

First Posted Date

Oct 30, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2019

Last Update Posted Date

Mar 5, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

198Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Apnea/Hypopnea Index	At primary healthcare	At baseline
Apnea/Hypopnea Index	At Sleep Lab Unit	At 3 months

Secondary Outcomes

Measure	Description	Time Frame
Cardiovascular risk factors		At baseline
History of cardiovascular or cerebrovascular disease		At baseline
Lung function tests

Other Outcomes

Not provided

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau		Barcelona		08025	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35033055	Derived	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.
32279702

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic