NCT03292523

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

February 6, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2021

Completed
Last Updated

April 29, 2022

Status Verified

April 1, 2022

Enrollment Period

3 years

First QC Date

September 21, 2017

Last Update Submit

April 28, 2022

Conditions

Keywords

Hyperventilation syndromeWork productivityAbsenteeismPresenteeism

Outcome Measures

Primary Outcomes (1)

  • Association between the WPAI score and the Nijmegen score

    At the time of diagnosis (Baseline)

Secondary Outcomes (4)

  • 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)

  • Association between the WPAI score and PaCO2

    At the time of diagnosis (Baseline)

  • Association between the WPAI score and the Cognitive Failure Questionnaire score

    At the time of diagnosis (Baseline)

Study Arms (1)

Hyperventilation syndrome

Other: questionnaire

Interventions

Work Productivity and Activity Impairment (WPAI) Multidimensional Dyspnea Profile (MDP) Baseline Dyspnea Index (BDI), MOS-SF36, Hospital Anxiety Depression (HAD) Cognitive Failure Questionnaire (CFQ).

Hyperventilation syndrome

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with confirmed hyperventilation syndrome, virgin of any treatment.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Calmette,CHU

Lille, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Cécile Chenivesse, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2017

First Posted

September 25, 2017

Study Start

February 6, 2018

Primary Completion

February 23, 2021

Study Completion

February 23, 2021

Last Updated

April 29, 2022

Record last verified: 2022-04

Locations