NCT05393115

Brief Summary

The study aims at investigating if time to respiratory muscle fatigue and metabolism are influenced by the pressure wave form mode applied during resistive breathing.

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
12

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable healthy

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

October 1, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

May 26, 2022

Status Verified

May 1, 2022

Enrollment Period

1.2 years

First QC Date

April 21, 2022

Last Update Submit

May 24, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time to task failure (Tlim)

    The time (s) from the subject starts to breathe under the experimental condition, and until task failure will be measured. Task failure is defied by either subject intolerance to continue or by lacking ability of the subject to maintain the target pressure and/or timing. From a previous publication (Bellemare and Grassino, JAP, 1982), it is estimated that subjects will reach Tlim between 30min to 1 hour. If breathing is continued after 1 hour, task failure will not happen as breathing can be continued indefinitely.

    Up to two months between the two different breathing trials (randomized order)

Secondary Outcomes (8)

  • Respiratory muscle pressures

    Up to two months between the two different breathing trials (randomized order)

  • Tidal volume

    Up to two months between the two different breathing trials (randomized order)

  • Respiratory work

    Up to two months between the two different breathing trials (randomized order)

  • Ratings of perceived exertion

    Up to two months between the two different breathing trials (randomized order)

  • Metabolism

    Up to two months between the two different breathing trials (randomized order)

  • +3 more secondary outcomes

Interventions

difference in time to failure from the two breathing modes

Also known as: Triangle wave breathing

Eligibility Criteria

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

You may qualify if:

  • Healthy men or women
  • Age ≥18 and ≤60 years
  • BMI ≥ 20 and ≤30

You may not qualify if:

  • Drug addiction defined as the use of cannabis, opioids or other drugs
  • Previous and present neurologic (e.g. ataxia), musculoskeletal (e.g. muscular dystrophy) or mental illnesses (e.g. schizophrenia)
  • History of mechanical ventilation, COVID-19 with respiratory complications, lung cancer
  • Part of lung resected
  • Presence of dyspepsia/heart-burn/abdominal pain
  • Presence of esophageal varices
  • Presence of liver disease
  • Presence of esophageal hernia
  • Pregnancy
  • Failure to comply with transcranial magnetic stimulation adult safety screen
  • History of epilepsy, metal implants in head or jaw
  • Acute or chronic lung diseases, e.g. asthma, COPD, bronchitis etc.
  • Lack of ability to cooperate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mathias Krogh Poulsen

Aalborg, Danmark, 9220, Denmark

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching Associate Professor

Study Record Dates

First Submitted

April 21, 2022

First Posted

May 26, 2022

Study Start

October 1, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

May 26, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations