NCT02201875

Brief Summary

We made a fortuitous observation of periodic breathing in a healthy subject coming to our outpatient mountain medicine consultation at Avicenne hospital in Bobigny (France). During this consultation, subjects perform a hypoxia exercise test, which allows a good prediction of their risk factors for severe high altitude illnesses. Surprisingly, breath-by-breath recording of the ventilation signal showed a periodic breathing pattern, which increased when the subject started to exercise in hypoxic conditions and was maintained during normoxic exercise. Therefore, our objective was to confirm this observation in a retrospective study led in 82 subjects who passed this test. We tested the hypothesis that subjects with a brisk ventilatory response to hypoxia might show a more pronounced periodic pattern of ventilation, due to a higher gain of the chemoreceptor feedback loop. Then, our objective is to investigate the mechanisms involved in the periodic pattern in healthy subjects, as a function of exercise intensity, altitude intensity, role of peripheral and central chemoreceptors to O2 and CO2. Finally, we want to investigate the possible role of this ventilatory instability in patients with obstructive or central apneas.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
unknown

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

January 22, 2014

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 28, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 28, 2014

Status Verified

July 1, 2014

Enrollment Period

9 months

First QC Date

January 22, 2014

Last Update Submit

July 24, 2014

Conditions

NormoxiaHypoxiaHyperoxiaHypercapnia

Keywords

hypoxiaexerciseperiodic breathinghypercapniaapneascardiac failure

Outcome Measures

Primary Outcomes (1)

  • Periodic pattern of ventilation

    Presence of oscillation in the ventilation signal

    The measure is made at the end of the 6-min exercise period, only once in each condition (normoxia, hypoxia, hyperoxia, hypercapnia),

Secondary Outcomes (2)

  • Oscillations in heart rate

    The measure is made at the end of the 6-min exercise period, only once in each condition (normoxia, hypoxia, hyperoxia, hypercapnia)

  • Oscillations in arterial blood pressure

    The measure is made at the end of the 6-min exercise period, only once in each condition (normoxia, hypoxia, hyperoxia, hypercapnia)

Study Arms (3)

Healthy subjects

male, aged 18-65 moderately trained healthy, no treatment

obstructive sleep apneas

patients with apnea/hypopnea index \> 15 BMI \< 30 Age \< 50 yrs

cardiac failure

NYHA class I to III ejection fraction \< 40% age \< 65 yrs BMI \< 30

Eligibility Criteria

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

Healthy subjects Patients with obstructive sleep apneas Patients with cardiac failure

You may qualify if:

  • depending on the group: see definition of groups

You may not qualify if:

  • BMI \> 30
  • history of severe cardiac arrhythmia
  • pulmonary hypertension
  • history of coronary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physiology Department

Bobigny, 93009, France

Location

Related Publications (3)

  • Richalet JP, Larmignat P, Poitrine E, Letournel M, Canoui-Poitrine F. Physiological risk factors for severe high-altitude illness: a prospective cohort study. Am J Respir Crit Care Med. 2012 Jan 15;185(2):192-8. doi: 10.1164/rccm.201108-1396OC. Epub 2011 Oct 27.

    PMID: 22071330BACKGROUND

  • Hermand E, Pichon A, Lhuissier FJ, Richalet JP. Low-frequency ventilatory oscillations in hypoxia are a major contributor to the low-frequency component of heart rate variability. Eur J Appl Physiol. 2019 Aug;119(8):1769-1777. doi: 10.1007/s00421-019-04166-x. Epub 2019 Jun 1.

    PMID: 31154522DERIVED

  • Hermand E, Lhuissier FJ, Richalet JP. Effect of dead space on breathing stability at exercise in hypoxia. Respir Physiol Neurobiol. 2017 Dec;246:26-32. doi: 10.1016/j.resp.2017.07.008. Epub 2017 Jul 29.

    PMID: 28760461DERIVED

MeSH Terms

Conditions

HypoxiaHyperoxiaHypercapniaMotor ActivityApneaHeart Failure

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorRespiration DisordersRespiratory Tract DiseasesHeart DiseasesCardiovascular Diseases

Central Study Contacts

Jean-Paul Richalet, MD, PhD

CONTACT

33148387758richalet@univ-paris13.fr

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department

Study Record Dates

First Submitted

January 22, 2014

First Posted

July 28, 2014

Study Start

September 1, 2014

Primary Completion

June 1, 2015

Study Completion

December 1, 2015

Last Updated

July 28, 2014

Record last verified: 2014-07

Locations

FR(1)