- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04668638
Impact of Respiratory Rehabilitation on Quality of Life in Patients With Hyperventilation Syndrome (RESPIR-HVS)
February 15, 2023 updated by: Centre Hospitalier Régional d'Orléans
Impact of Respiratory Rehabilitation on Quality of Life, Measures by the SF-36 Score, in Patients With Hyperventilation Syndrome: Crossover, Prospective and Randomized Study
The hyperventilation syndrome is a quite frequent pathology, affecting up to 10% of the general population and 40% of the asthmatic population.
Its physiopathology is still badly known and even if it is a benign affection, its associated comorbidities and symptomatology greatly decrease the patients' quality of life.
Yet, no medicinal treatments have been proved useful, but prescribers noticed improvements after physiotherapy.
Given that the physiotherapy impact on hyperventilation syndrome is not well described in the literature, this study aims to scientifically ascertain physiotherapy benefits on quality of life and symptomatology in hyperventilation syndrome-suffering patients.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Elodie POUGOUE TOUKO
- Phone Number: +33238744086
- Email: elodie.pougoue-touko@chr-orleans.fr
Study Locations
-
-
-
Orléans, France
- Recruiting
- CHR d'Orléans
-
Contact:
- Nicolas LEBRUN
- Phone Number: +33238514444
- Email: nicolas.lebrun@chr-orleans.fr
-
Principal Investigator:
- Nicolas LEBRUN
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Positive hyperventilation syndrome diagnosis
- Having a social security insurance
- Being at least 18 years old
- Having given their written consent
Exclusion Criteria:
- Being put under guardianship or curatorship
- Having seen a physiotherapist for a respiratory rehabilitation in the last three months
- Suffering from a chronic and degenerative pathology (chronic obstructive pulmonary disease, Parkinson's disease, idiopathic fibrosis, …)
- Not being able to receive the respiratory rehabilitation from our care providers
- Already having received a rehabilitation for hyperventilation syndrome
- Not speaking French or not being unable to complete the questionnaires
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Control group
Group 1 (Control Group) will not immediately receive respiratory rehabilitation but between the 2nd and 4th months postdiagnosis.
|
Respiratory rehabilitation includes education, hypoventilation exercises, diaphragmatic breathing exercises, relaxation, retraining, others.
|
Other: Intervention group
Group 2 (Intervention Group) will immediately receive rehabilitation between the diagnosis and the 2nd month postdiagnosis.
|
Respiratory rehabilitation includes education, hypoventilation exercises, diaphragmatic breathing exercises, relaxation, retraining, others.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of respiratory rehabilitation on Quality of life
Time Frame: Day 0
|
Quality of life will be evaluated with the SF-36 score
|
Day 0
|
Incidence of respiratory rehabilitation on Quality of life
Time Frame: Month 2
|
Quality of life will be evaluated with the SF-36 score
|
Month 2
|
Incidence of respiratory rehabilitation on Quality of life
Time Frame: Month 4
|
Quality of life will be evaluated with the SF-36 score
|
Month 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in symptomatology
Time Frame: Day 0
|
Change in symptomatology will be evaluated on the Nijmegen questionnaire
|
Day 0
|
Change in symptomatology
Time Frame: Month 2
|
Change in symptomatology will be evaluated on the Nijmegen questionnaire
|
Month 2
|
Change in symptomatology
Time Frame: Month 4
|
Change in symptomatology will be evaluated on the Nijmegen questionnaire
|
Month 4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Louis-François BIRNESSER, CHR Orleans
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Jones M, Harvey A, Marston L, O'Connell NE. Breathing exercises for dysfunctional breathing/hyperventilation syndrome in adults. Cochrane Database Syst Rev. 2013 May 31;(5):CD009041. doi: 10.1002/14651858.CD009041.pub2.
- Thomas M, McKinley RK, Freeman E, Foy C. Prevalence of dysfunctional breathing in patients treated for asthma in primary care: cross sectional survey. BMJ. 2001 May 5;322(7294):1098-100. doi: 10.1136/bmj.322.7294.1098.
- van Dixhoorn J, Duivenvoorden HJ. Efficacy of Nijmegen Questionnaire in recognition of the hyperventilation syndrome. J Psychosom Res. 1985;29(2):199-206. doi: 10.1016/0022-3999(85)90042-x.
- Vansteenkiste J, Rochette F, Demedts M. Diagnostic tests of hyperventilation syndrome. Eur Respir J. 1991 Apr;4(4):393-9.
- Gardner WN. The pathophysiology of hyperventilation disorders. Chest. 1996 Feb;109(2):516-34. doi: 10.1378/chest.109.2.516. No abstract available.
- Lewis RA, Howell JB. Definition of the hyperventilation syndrome. Bull Eur Physiopathol Respir. 1986 Mar-Apr;22(2):201-5.
- Lewis T, Cotton, Barcroft J, Dufton D, Milroy TR, Parsons TR. BREATHLESSNESS IN SOLDIERS SUFFERING FROM IRRITABLE HEART. Br Med J. 1916 Oct 14;2(2911):517-9. doi: 10.1136/bmj.2.2911.517. No abstract available.
- Nixon PG. Effort syndrome: hyperventilation and reduction of anaerobic threshold. Biofeedback Self Regul. 1994 Jun;19(2):155-69. doi: 10.1007/BF01776488.
- 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.
- Kraft AR, Hoogduin CA. The hyperventilation syndrome. A pilot study on the effectiveness of treatment. Br J Psychiatry. 1984 Nov;145:538-42. doi: 10.1192/bjp.145.5.538.
- Van De Ven LL, Mouthaan BJ, Hoes MJ. Treatment of the hyperventilation syndrome with bisoprolol: a placebo-controlled clinical trial. J Psychosom Res. 1995 Nov;39(8):1007-13. doi: 10.1016/0022-3999(95)00508-0.
- Hoes MJ, Colla P, Folgering H. Clomipramine treatment of hyperventilation syndrome. Pharmakopsychiatr Neuropsychopharmakol. 1980 Jan;13(1):25-8. doi: 10.1055/s-2007-1019606.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 10, 2021
Primary Completion (Anticipated)
January 1, 2025
Study Completion (Anticipated)
January 1, 2025
Study Registration Dates
First Submitted
December 9, 2020
First Submitted That Met QC Criteria
December 9, 2020
First Posted (Actual)
December 16, 2020
Study Record Updates
Last Update Posted (Estimate)
February 16, 2023
Last Update Submitted That Met QC Criteria
February 15, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHRO-2020-19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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