Work Productivity in Hyperventilation Syndrome | NCT03292523

Studies
Work Productivity in Hyperventilation Syndrome

NCT03292523

Sponsor

University Hospital, Lille

Status

Completed

Last Update Posted

Apr 29, 2022Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Hyperventilation Syndrome

Interventions

questionnaire

Countries

France

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

ID	Type	Description	Link
2017-A01542-51	Other Identifier	ID-RCB number, ANSM

Status Module

Record Verification Date

Apr 2022

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

Feb 6, 2018Actual

Primary Completion Date

Feb 23, 2021Actual

Completion Date

Feb 23, 2021Actual

First Submitted Date

Sep 21, 2017

First Submission Date that Met QC Criteria

Sep 21, 2017

First Posted Date

Sep 25, 2017Actual

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

Apr 28, 2022

Last Update Posted Date

Apr 29, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Hyperventilation syndrome is associated with impaired quality of life. The aim of the study is to assess the relationship between work productivity, including absenteeism and presenteeism, and the severity of hyperventilation syndrome

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

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hyperventilation syndrome			Other: questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
questionnaire	Other	Work Productivity and Activity Impairment (WPAI) Multidimensional Dyspnea Profile (MDP) Baseline Dyspnea Index (BDI), MOS-SF36, Hospital Anxiety Depression (HAD) Cognitive Failure Questionnaire (CFQ).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Association between the WPAI score and the Nijmegen score		At the time of diagnosis (Baseline)

Secondary Outcomes

Measure	Description	Time Frame
Association between the WPAI score and dyspnea scales		At the time of diagnosis (Baseline)
Association between the WPAI score and quality of life scores		At the time of diagnosis (Baseline)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Holders of employment contracts for at least 8 days
Diagnosis of hyperventilation syndrome confirmed by:

Compatible symptoms and at least two symptoms reproduced by the hyperventilation challenge test: Nijmegen's score> 23 ; Demonstration of alveolar hyperventilation ( Either on rest blood and / or at rest (PaCO2 at rest <36 mmHg and D (A-a) O2 normal; Either during the HV test (increased recovery time of the basic PETCO2 after voluntary hyperventilation (greater than 5 minutes)

Exclusion Criteria:

Existence of another chronic pulmonary disease (asthma, bronchial dilation, COPD, diffuse interstitial pneumonia, neuromuscular pathology ...) or cardiac (rhythm disorder, ischemic heart disease ...) which can participate in dyspnea
Psychiatric illness / psychotropic treatment
Pregnancy
Patient already included in a clinical research protocol involving new therapeutics may not be included in this protocol
Specific physiotherapy or previous training

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients with confirmed hyperventilation syndrome, virgin of any treatment.

Sampling Method

Probability Sample

Name	Affiliation	Role
Cécile Chenivesse, MD	University Hospital, Lille	Principal Investigator

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided