NCT04668638

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

December 9, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 16, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

March 10, 2021

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

July 22, 2025

Status Verified

July 1, 2025

Enrollment Period

4.3 years

First QC Date

December 9, 2020

Last Update Submit

July 17, 2025

Conditions

Keywords

Hyperventilation syndromeRespiratory rehabilitationQuality of Life

Outcome Measures

Primary Outcomes (3)

  • Incidence of respiratory rehabilitation on Quality of life

    Quality of life will be evaluated with the SF-36 score

    Day 0

  • Incidence of respiratory rehabilitation on Quality of life

    Quality of life will be evaluated with the SF-36 score

    Month 2

  • Incidence of respiratory rehabilitation on Quality of life

    Quality of life will be evaluated with the SF-36 score

    Month 4

Secondary Outcomes (3)

  • Change in symptomatology

    Day 0

  • Change in symptomatology

    Month 2

  • Change in symptomatology

    Month 4

Study Arms (2)

Control group

OTHER

Group 1 (Control Group) will not immediately receive respiratory rehabilitation but between the 2nd and 4th months postdiagnosis.

Other: Respiratory rehabilitation

Intervention group

OTHER

Group 2 (Intervention Group) will immediately receive rehabilitation between the diagnosis and the 2nd month postdiagnosis.

Other: Respiratory rehabilitation

Interventions

Respiratory rehabilitation includes education, hypoventilation exercises, diaphragmatic breathing exercises, relaxation, retraining, others.

Control groupIntervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Positive hyperventilation syndrome diagnosis
  • Having a social security insurance
  • Being at least 18 years old
  • Having given their written consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHR d'Orléans

Orléans, France

Location

Related Publications (12)

  • Gardner WN. The pathophysiology of hyperventilation disorders. Chest. 1996 Feb;109(2):516-34. doi: 10.1378/chest.109.2.516. No abstract available.

    PMID: 8620731BACKGROUND
  • Lewis RA, Howell JB. Definition of the hyperventilation syndrome. Bull Eur Physiopathol Respir. 1986 Mar-Apr;22(2):201-5.

    PMID: 3708188BACKGROUND
  • 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.

    PMID: 11337441BACKGROUND
  • 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.

    PMID: 20768329BACKGROUND
  • 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.

    PMID: 4009520BACKGROUND
  • Vansteenkiste J, Rochette F, Demedts M. Diagnostic tests of hyperventilation syndrome. Eur Respir J. 1991 Apr;4(4):393-9.

    PMID: 1855568BACKGROUND
  • Nixon PG. Effort syndrome: hyperventilation and reduction of anaerobic threshold. Biofeedback Self Regul. 1994 Jun;19(2):155-69. doi: 10.1007/BF01776488.

    PMID: 7918753BACKGROUND
  • 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
  • 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.

    PMID: 6388711BACKGROUND
  • 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.

    PMID: 8926595BACKGROUND
  • 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.

    PMID: 7367465BACKGROUND
  • 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;2013(5):CD009041. doi: 10.1002/14651858.CD009041.pub2.

    PMID: 23728685BACKGROUND

Study Officials

  • Louis-François BIRNESSER

    CHR Orléans

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: Patients will be divided into two groups: * Group 1 (Control Group) will not immediately receive respiratory rehabilitation but between the 2nd and 4th months postdiagnosis. * Group 2 (Intervention Group) will immediately receive rehabilitation between the diagnosis and the 2nd month postdiagnosis.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2020

First Posted

December 16, 2020

Study Start

March 10, 2021

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

July 22, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations