NCT05488301

Brief Summary

Hyperventilation syndrome induce dyspnea and altered quality of life. the aim of this study is to assess the impact of chest physiotherapy on hyperventilation syndrome' symptoms

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 4, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

1.8 years

First QC Date

May 27, 2022

Last Update Submit

August 30, 2023

Conditions

Keywords

hyperventilationquality of lifedyspneaNijmegenanxiety

Outcome Measures

Primary Outcomes (1)

  • change of Nijmegen score

    Nijmegen score is measured at baseline and after 5 weeks. The Nijmegen questionnaire allows to assess hyperventilation symptoms. the minimum and maximum values are between 0 to 64, and higher scores mean a worse outcome.

    5 weeks

Secondary Outcomes (4)

  • change of Nijmegen Score

    1 week

  • change of Hospital Anxiety and Depression score (HAD)

    5 weeks

  • change of Short Form-36 score (SF-36)

    5 weeks

  • change of Dyspnea-12 score

    5 weeks

Interventions

chest physiotherapy session including: * nasal ventilation * decrease of respiratory rate without increasement of Tidal volume * abdomino-diaphragmatic ventilation

Eligibility Criteria

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

patients with hyperventilation syndrome adressed for chest physiotherapy

You may qualify if:

  • patients addressed for hyperventilation syndrome
  • patient aged 18 years or over
  • patient able to consent and having sign a consent form

You may not qualify if:

  • respiratory disease (COPD, interstitial lung disease, bronchiectasis, cystic fibrosis, uncontrolled asthma)
  • patient with an inability to complete questionaires
  • refusal of participation
  • patient under tutorship or curatorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BEAUMONT

Morlaix, 29600, France

Location

Related Publications (2)

  • Chenivesse C, Similowski T, Bautin N, Fournier C, Robin S, Wallaert B, Perez T. Severely impaired health-related quality of life in chronic hyperventilation patients: exploratory data. Respir Med. 2014 Mar;108(3):517-23. doi: 10.1016/j.rmed.2013.10.024. Epub 2013 Nov 7.

    PMID: 24269004BACKGROUND
  • Kiesel K, Burklow M, Garner MB, Hayden J, Hermann AJ, Kingshott E, McCullough G, Ricard R, Stubblefield G, Volz J, Waskiewicz D, Englert A. EXERCISE INTERVENTION FOR INDIVIDUALS WITH DYSFUNCTIONAL BREATHING: A MATCHED CONTROLLED TRIAL. Int J Sports Phys Ther. 2020 Feb;15(1):114-125.

    PMID: 32089963BACKGROUND

MeSH Terms

Conditions

HyperventilationDyspneaAnxiety Disorders

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 27, 2022

First Posted

August 4, 2022

Study Start

October 1, 2021

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

August 31, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations