HyperventilationSHVNCT05488301
Effects of Chest Physiotherapy in Hyperventilation Syndrome
An observational study of Hyperventilation, run by Centre Hospitalier des Pays de Morlaix at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperventilation
- What is being tested?
- chest physiotherapy
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2021to 1 Aug 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with hyperventilation syndrome adressed for chest physiotherapy
Who may be able to join
- patients addressed for hyperventilation syndrome
- patient aged 18 years or over
- patient able to consent and having sign a consent form
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Chest Physiotherapy in Hyperventilation Syndrom : a Multicentric Observational Study
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
- Conditions
- Hyperventilation
- Being tested
- chest physiotherapy
- Keywords
- hyperventilation, quality of life, dyspnea, Nijmegen, anxiety
- Medical subject headings
- Hyperventilation, Dyspnea, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chest physiotherapyOther
chest physiotherapy session including:
- nasal ventilation
- decrease of respiratory rate without increasement of Tidal volume
- abdomino-diaphragmatic ventilation
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 weeks
Secondary outcomes (4)
change of Nijmegen Score
Nijemegen score is measured at baseline and after 1 week. 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.
Measured: 1 week
change of Hospital Anxiety and Depression score (HAD)
Anxiety and depression scores are measured at baseline and after 5 weeks. the minimum and maximum values are between 0 to 21 for each item (Anxiety and Depression), and higher scores mean a worse outcome.
Measured: 5 weeks
change of Short Form-36 score (SF-36)
SF 36 score is measured at baseline and after 5 weeks. SF36 allows to assess quality of life.
the minimum and maximum values are between 0 to 100, and higher scores mean a better outcome.
Measured: 5 weeks
change of Dyspnea-12 score
Dyspnea-12 is measured at at baseline and after 5 weeks.
Dyspnea-12 questionnaire allows to assess sensorial and emotional component of dyspnea. The minimum and maximum values are between à to 36, and higher scores mean a worse outcome.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start1 Oct 2021
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
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 HyperventilationStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier des Pays de Morlaix
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Beaumont, Centre Hospitalier des Pays de Morlaix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488301
- Sponsor's protocol ID
- CHPMorlaix
- Other IDs
- CEPRO 2021-028
- Acronym
- SHV
- Status last verified
- Aug 2023
- First submitted
- 27 May 2022
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24269004Kiesel 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.
PubMed 32089963
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Chest Physiotherapy in Hyperventilation Syndrom : a Multicentric Observational Study
- ClinicalTrials.gov ID
- NCT05488301
- Acronym / sponsor ID
- SHV / CHPMorlaix
- Conditions
- Hyperventilation
- Keywords
- hyperventilation, quality of life, dyspnea, Nijmegen, anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Centre Hospitalier des Pays de MorlaixUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 4 Aug 2022 (actual)
- 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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with hyperventilation syndrome adressed for chest physiotherapy
Key inclusion criteria (3 listed)
- patients addressed for hyperventilation syndrome
- patient aged 18 years or over
- patient able to consent and having sign a consent form
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chest physiotherapychest physiotherapy session including: * nasal ventilation * decrease of respiratory rate without increasement of Tidal volume * abdomino-diaphragmatic ventilation | Other | – |
Primary outcome
change of Nijmegen score
Time frame: 5 weeks
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.
4 secondary outcomes
change of Nijmegen Score
Time frame: 1 week
change of Hospital Anxiety and Depression score (HAD)
Time frame: 5 weeks
change of Short Form-36 score (SF-36)
Time frame: 5 weeks
change of Dyspnea-12 score
Time frame: 5 weeks
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 31 Aug 2023.
- Background: PubMed 24269004Chenivesse 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.
- Background: PubMed 32089963Kiesel 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.
- Individual participant dataSharing planned: No
Related trials for Hyperventilation
Not yet recruitingObservational study
Symptomatic Hyperventilation in Individuals Living With Stroke
Stroke, Hyperventilation Syndrome
Not yet recruiting
Hyperventilation Effects on Bodily Self-Consciousness
Bodily Self-Consciousness, Interoception
Recruiting
Optimizing Liver MRI Using Breath-Holding With and Without Oxygen
MRI, MRI Image Enhancement
Active, not recruiting
Voluntary Isocapnic Hyperpnea in Hypoxia to Mitigate Acute Mountain Sickness
Acute Mountain Sickness
Enrolling by invitation
Can You Breathe Your Way To Better Health?
Cancer, Chronic Stress
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 Hyperventilation, run by Centre Hospitalier des Pays de Morlaix at 1 site in France.
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 3 inclusion and 4 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 31 Aug 2023. 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 France. 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?
change of Nijmegen score (time frame: 5 weeks). 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 NCT05488301, 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 31 Aug 2023.