HealthyNCT05393115
Respiratory Muscle Fatigue at Different Breathing Modes
A study testing Square wave breathing in people with Healthy, run by Aalborg University at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Square wave breathing
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2021to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men or women
- Age ≥18 and ≤60 years
- BMI ≥ 20 and ≤30
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Mathias Krogh Poulsen
Aalborg, Danmark, 9220
Mathias K Poulsen, 28297625 ext. 0045, mkpo@hst.aau.dk
About this study
Official title: Does Inspiratory Pressure Wave Form Influence Respiratory Muscle Fatigue and Metabolism During Resistive Breathing
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.
Read the detailed description
In healthy subjects fitted with a nasogastric double balloon catheter and breathing at a resistance, the investigators will measure time to failure, Borg ratings, VO2, VCO2, flow, esophageal-, gastric- and airway-pressure. This will be done during breathing at either a square wave or triangle wave pressure waveform, in random order and trials separated by >two days. Further respiratory muscle fatigue will be investigated pre and post intervention by maximal esophageal pressure generation (voluntary and with cervical magnetic stimulation).
- Conditions
- Healthy
- Being tested
- Square wave breathing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Square wave breathingOther
Also called Triangle wave breathing
difference in time to failure from the two breathing modes
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to two months between the two different breathing trials (randomized order)
Secondary outcomes (8)
Respiratory muscle pressures
Respiratory muscle pressure will be measured by esophageal and gastric pressure (in cmH2O) using a naso gastric catheter fitted with double balloons (Nutrivent) connected to a pressure sensor (ICU lab, KleisTek).
Measured: Up to two months between the two different breathing trials (randomized order)
Tidal volume
Tidal Volume (ml) will be measured with a flowsensor (Hans Rudolph) through a pressure box (ICU lab, KleisTek)
Measured: Up to two months between the two different breathing trials (randomized order)
Respiratory work
Work of breathing (j), will be calculated from outcome measure 2 and 9 (pressure (cmH2O) and insp. and expiratory time (s)). Measured with pressure box (ICU lab, KleisTek)
Measured: Up to two months between the two different breathing trials (randomized order)
Ratings of perceived exertion
Borg Dyspnea Scale, from 0-10 where 0 is no effort at all and 10 is maximal breathing effort.
Measured: Up to two months between the two different breathing trials (randomized order)
Metabolism
Energy expenditure calculated from VO2 (ml/min) nad VCO2 (ml/min) with e.g Weir equation. VO2 and VCO2 are measured with Beacon (Mermaid care).
Measured: Up to two months between the two different breathing trials (randomized order)
Respiratory rate
Respiratory rate (breaths/min) will be measured with a flowsensor (Hans Rudolph) through a pressure box (ICU lab, KleisTek)
Measured: Up to two months between the two different breathing trials (randomized order)
Minute ventilation
Minyte ventilation (l/min) will be measured with a flowsensor (Hans Rudolph) through a pressure box (ICU lab, KleisTek)
Measured: Up to two months between the two different breathing trials (randomized order)
Insp. and expiratory time
Insp. and expiratory time (s) will be measured with a flowsensor (Hans Rudolph) through a pressure box (ICU lab, KleisTek)
Measured: Up to two months between the two different breathing trials (randomized order)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start1 Oct 2021
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mathias Krogh Poulsen, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393115
- Sponsor's protocol ID
- Eso_pres_fatigue
- Status last verified
- May 2022
- First submitted
- 21 Apr 2022
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Inspiratory Pressure Wave Form Influence Respiratory Muscle Fatigue and Metabolism During Resistive Breathing
- ClinicalTrials.gov ID
- NCT05393115
- Acronym / sponsor ID
- Eso_pres_fatigue
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 26 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In healthy subjects fitted with a nasogastric double balloon catheter and breathing at a resistance, the investigators will measure time to failure, Borg ratings, VO2, VCO2, flow, esophageal-, gastric- and airway-pressure. This will be done during breathing at either a square wave or triangle wave pressure waveform, in random order and trials separated by >two days. Further respiratory muscle fatigue will be investigated pre and post intervention by maximal esophageal pressure generation (voluntary and with cervical magnetic stimulation).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy men or women
- Age ≥18 and ≤60 years
- BMI ≥ 20 and ≤30
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Square wave breathingAlso: Triangle wave breathingdifference in time to failure from the two breathing modes | Other | – |
Primary outcome
Time to task failure (Tlim)
Time frame: Up to two months between the two different breathing trials (randomized order)
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.
8 secondary outcomes
Respiratory muscle pressures
Time frame: Up to two months between the two different breathing trials (randomized order)
Tidal volume
Time frame: Up to two months between the two different breathing trials (randomized order)
Respiratory work
Time frame: Up to two months between the two different breathing trials (randomized order)
Ratings of perceived exertion
Time frame: Up to two months between the two different breathing trials (randomized order)
Metabolism
Time frame: Up to two months between the two different breathing trials (randomized order)
Respiratory rate
Time frame: Up to two months between the two different breathing trials (randomized order)
Minute ventilation
Time frame: Up to two months between the two different breathing trials (randomized order)
Insp. and expiratory time
Time frame: Up to two months between the two different breathing trials (randomized order)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Square wave breathing in people with Healthy, run by Aalborg University at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to task failure (Tlim) (time frame: Up to two months between the two different breathing trials (randomized order)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022.