NCT01881945

Brief Summary

The aim of the study was to validate tools of physiological signal processing and interpretation on healthy human volunteers in order to improve the understanding in respiratory physiology and its interactions with heart function, and swallowing.

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

September 1, 2008

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2013

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 20, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

June 20, 2013

Status Verified

June 1, 2013

Enrollment Period

5 years

First QC Date

May 24, 2013

Last Update Submit

June 17, 2013

Conditions

Keywords

SwallowingHyperventilation

Outcome Measures

Primary Outcomes (6)

  • Heart rate

    Heart rate is calculated on electrocardiograph

    one measure within two weeks of inclusion

  • end tidal CO2

    end tidal CO2 of each breath measured with an infrared CO2 analyzer

    one measure within two weeks of inclusion

  • Non invasive arterial pressure

    one measure within two weeks of inclusion

  • Non invasive stroke volume

    measured with impedance cardiography

    one measure within two weeks of inclusion

  • Inspiratory and expiratory times

    obtained for each breath with flow signal

    one measure within two weeks of inclusion

  • Tidal volume

    obtained for each breath with flow signal

    one measure within two weeks of inclusion

Study Arms (1)

Physiological measurments

EXPERIMENTAL
Other: Non-invasive physiological signal recording on healthy volunteer

Interventions

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy subject
  • between 18 and 60 years old

You may not qualify if:

  • patient
  • person protected by the law

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratoire TIMC-IMAG

La Tronche, 38700, France

RECRUITING

Related Publications (1)

  • Besleaga T, Blum M, Briot R, Vovc V, Moldovanu I, Calabrese P. Individuality of breathing during volitional moderate hyperventilation. Eur J Appl Physiol. 2016 Jan;116(1):217-25. doi: 10.1007/s00421-015-3260-3. Epub 2015 Sep 23.

MeSH Terms

Conditions

Respiratory AspirationHyperventilation

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • BRIOT Raphael, MCU-PH

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Central Study Contacts

BRIOT Raphael, MCU-PH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2013

First Posted

June 20, 2013

Study Start

September 1, 2008

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

June 20, 2013

Record last verified: 2013-06

Locations