Peak Cough Flow MeasurementPCF P/INCT07631481
Posture, Interface, and Peak Cough Flow
A study testing Facial mask (V2 Mask™, Hans Rudolph) and Mouthpiece (Pulmosafe, Lemon Medical) with nose clip in people with Peak Cough Flow Measurement, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Cough is a key airway protective mechanism requiring coordinated neuromuscular function. Peak cough flow (PCF) is a simple, non-invasive measure widely used to assess cough effectiveness and guide clinical decisions. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Peak Cough Flow Measurement
- What is being tested?
- Facial mask (V2 Mask™, Hans Rudolph) and Mouthpiece (Pulmosafe, Lemon Medical) with nose clip
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- 1 May 2024to 21 May 2026
- 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 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged 20 to 30 years
- Non-smoker
- Self-reported good health status
- Able to perform all four randomized cough conditions
Who cannot join
- Any chronic disease
- Signs of airway obstruction on clinical examination
- Auscultatory abnormalities (wheezing or stridor) prior to testing
- Incomplete participation in all four conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Body Posture and Interface Effects on Peak Cough Flow in Healthy Adults: A Randomized Crossover Study
Cough is a key airway protective mechanism requiring coordinated neuromuscular function. Peak cough flow (PCF) is a simple, non-invasive measure widely used to assess cough effectiveness and guide clinical decisions. Current ATS/ERS guidelines recommend measuring PCF in a seated position using a mouthpiece with a nose clip; however, this setup is not always feasible in clinical practice. Some patients cannot maintain posture or ensure an adequate mouthpiece seal, making a facial mask a potential alternative. The influence of body position and interface on PCF measurements remains unclear, with limited evidence from randomized crossover studies.
This study aims to evaluate the effects of body position (sitting vs standing) and measurement interface (mouthpiece vs facial mask) on PCF in healthy young adults. In a randomized within-subject crossover design, participants perform PCF measurements under four conditions (Sit-Mask, Stand-Mask, Sit-Mouthpiece, Stand-Mouthpiece) during a single session. The findings will help inform more flexible and standardized PCF assessment procedures in clinical practice.
Read the detailed description
Cough is an essential protective mechanism that requires intact neuromuscular function and precise coordination across the inspiratory, compressive, and expulsive phases. Peak cough flow (PCF) is a simple, non-invasive measure, widely used to assess cough intensity and guide clinical decisions. Because of its clinical relevance, standardized procedures are essential. Current ATS/ERS recommendations specify seated testing with a mouthpiece and a noseclip (MP). However, this configuration is not always possible or consistently used in practice. Many patients cannot maintain adequate posture or mouthpiece seal, and a facial mask (FM) may be a feasible alternative. Evidence regarding the effects of posture (sitting vs standing) and interface (MP vs FM) on PCF remains inconsistent, with few studies comparing both factors within the same individuals using a randomized crossover design.
Aims To determine the effects of body position (sitting vs standing) and measurement interface (FM vs MP) on PCF in healthy young adults. We hypothesized that both factors would influence PCF.
Methods This randomized within subject crossover study included healthy, non smoking adults aged 20-30 years. Exclusion criteria were chronic disease, top-level athletic status and any signs of obstruction and/or auscultatory noise (wheezing or stridor) before the trial. Each participant completed four randomized conditions during a single session: Sit-Mask, Stand-Mask, Sit-Mouthpiece, and Stand-Mouthpiece. PCF (L/s) was measured using an ultrasonic spirometer (SpiroScout, Ganshorn). For each condition, participants performed three standardized maneuvers consisting of three tidal breaths, a rapid inspiration to total lung capacity, and a maximal cough; the highest PCF per condition was used for analysis. A two factor repeated measures ANOVA evaluated the effects of posture, interface, and their interaction (α = 0.05).
- Conditions
- Peak Cough Flow Measurement
- Being tested
- Facial mask (V2 Mask™, Hans Rudolph), Mouthpiece (Pulmosafe, Lemon Medical) with nose clip
- Keywords
- peak cough flow, cough, interfaces, postures
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facial mask (V2 Mask™, Hans Rudolph)Device
Peak cough flow measured in the seated position. The facial mask (V2 Mask™, Hans Rudolph, Inc., Kansas, USA; size fitted to participant) was connected to an ultrasonic spirometer (SpiroScout, Ganshorn) via a PFT filter. Participants performed three tidal breaths followed by a maximal cough, repeated three times.
Facial mask (V2 Mask™, Hans Rudolph)Device
Peak cough flow measured in the standing position. Same device and procedure as Sit-Mask condition.
Mouthpiece (Pulmosafe, Lemon Medical) with nose clipDevice
Peak cough flow measured in the seated position. The mouthpiece (Pulmosafe, Lemon Medical GmbH, Hammelburg, Germany) was used with a nose clip and connected to an ultrasonic spirometer (SpiroScout, Ganshorn) via a PFT filter. Participants performed three tidal breaths followed by a maximal cough, repeated three times.
Mouthpiece (Pulmosafe, Lemon Medical) with nose clipDevice
Peak cough flow measured in the standing position. Same device and procedure as Sit-Mouthpiece condition.
| Study group | Role | What they receive |
|---|---|---|
| Sit-Mask | Active comparator | Not described Receives: Device: Facial mask (V2 Mask™, Hans Rudolph) |
| Stand-Mask | Active comparator | Not described Receives: Device: Facial mask (V2 Mask™, Hans Rudolph) |
| Sit-Mouthpiece | Active comparator | Not described Receives: Device: Mouthpiece (Pulmosafe, Lemon Medical) with nose clip |
| Stand-Mouthpiece | Active comparator | Not described Receives: Device: Mouthpiece (Pulmosafe, Lemon Medical) with nose clip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak cough Flow (PCF)
PCF measurement in L/s
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start1 May 2024
- Primary completion31 Aug 2024
- Study completion21 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peak Cough Flow MeasurementStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas AUDAG, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07631481
- Sponsor's protocol ID
- 2023/14JUI/264
- Acronym
- PCF P/I
- Status last verified
- Jun 2026
- First submitted
- 21 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
PubMed 16055882Brennan M, McDonnell MJ, Duignan N, Gargoum F, Rutherford RM. The use of cough peak flow in the assessment of respiratory function in clinical practice- A narrative literature review. Respir Med. 2022 Mar;193:106740. doi: 10.1016/j.rmed.2022.106740. Epub 2022 Jan 15.
PubMed 35123355
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Posture and Interface Effects on Peak Cough Flow in Healthy Adults: A Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT07631481
- Acronym / sponsor ID
- PCF P/I / 2023/14JUI/264
- Conditions
- Peak Cough Flow Measurement
- Keywords
- peak cough flow, cough, interfaces, postures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 21 May 2026 (actual)
- First posted
- 8 Jun 2026 (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.
Cough is a key airway protective mechanism requiring coordinated neuromuscular function. Peak cough flow (PCF) is a simple, non-invasive measure widely used to assess cough effectiveness and guide clinical decisions. Current ATS/ERS guidelines recommend measuring PCF in a seated position using a mouthpiece with a nose clip; however, this setup is not always feasible in clinical practice. Some patients cannot maintain posture or ensure an adequate mouthpiece seal, making a facial mask a potential alternative. The influence of body position and interface on PCF measurements remains unclear, with limited evidence from randomized crossover studies.
This study aims to evaluate the effects of body position (sitting vs standing) and measurement interface (mouthpiece vs facial mask) on PCF in healthy young adults. In a randomized within-subject crossover design, participants perform PCF measurements under four conditions (Sit-Mask, Stand-Mask, Sit-Mouthpiece, Stand-Mouthpiece) during a single session. The findings will help inform more flexible and standardized PCF assessment procedures in clinical practice.
Detailed description
Cough is an essential protective mechanism that requires intact neuromuscular function and precise coordination across the inspiratory, compressive, and expulsive phases. Peak cough flow (PCF) is a simple, non-invasive measure, widely used to assess cough intensity and guide clinical decisions. Because of its clinical relevance, standardized procedures are essential. Current ATS/ERS recommendations specify seated testing with a mouthpiece and a noseclip (MP). However, this configuration is not always possible or consistently used in practice. Many patients cannot maintain adequate posture or mouthpiece seal, and a facial mask (FM) may be a feasible alternative. Evidence regarding the effects of posture (sitting vs standing) and interface (MP vs FM) on PCF remains inconsistent, with few studies comparing both factors within the same individuals using a randomized crossover design.
Aims To determine the effects of body position (sitting vs standing) and measurement interface (FM vs MP) on PCF in healthy young adults. We hypothesized that both factors would influence PCF.
Methods This randomized within subject crossover study included healthy, non smoking adults aged 20-30 years. Exclusion criteria were chronic disease, top-level athletic status and any signs of obstruction and/or auscultatory noise (wheezing or stridor) before the trial. Each participant completed four randomized conditions during a single session: Sit-Mask, Stand-Mask, Sit-Mouthpiece, and Stand-Mouthpiece. PCF (L/s) was measured using an ultrasonic spirometer (SpiroScout, Ganshorn). For each condition, participants performed three standardized maneuvers consisting of three tidal breaths, a rapid inspiration to total lung capacity, and a maximal cough; the highest PCF per condition was used for analysis. A two factor repeated measures ANOVA evaluated the effects of posture, interface, and their interaction (α = 0.05).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sit-Mask | Active comparator | Device: Facial mask (V2 Mask™, Hans Rudolph) |
| Stand-Mask | Active comparator | Device: Facial mask (V2 Mask™, Hans Rudolph) |
| Sit-Mouthpiece | Active comparator | Device: Mouthpiece (Pulmosafe, Lemon Medical) with nose clip |
| Stand-Mouthpiece | Active comparator | Device: Mouthpiece (Pulmosafe, Lemon Medical) with nose clip |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adults aged 20 to 30 years
- Non-smoker
- Self-reported good health status
- Able to perform all four randomized cough conditions
Key exclusion criteria (4 listed)
- Any chronic disease
- Signs of airway obstruction on clinical examination
- Auscultatory abnormalities (wheezing or stridor) prior to testing
- Incomplete participation in all four conditions
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 |
|---|---|---|
| Facial mask (V2 Mask™, Hans Rudolph)Peak cough flow measured in the seated position. The facial mask (V2 Mask™, Hans Rudolph, Inc., Kansas, USA; size fitted to participant) was connected to an ultrasonic spirometer (SpiroScout, Ganshorn) via a PFT filter. Participants performed three tidal breaths followed by a maximal cough, repeated three times. | Device | Sit-Mask |
| Facial mask (V2 Mask™, Hans Rudolph)Peak cough flow measured in the standing position. Same device and procedure as Sit-Mask condition. | Device | Stand-Mask |
| Mouthpiece (Pulmosafe, Lemon Medical) with nose clipPeak cough flow measured in the seated position. The mouthpiece (Pulmosafe, Lemon Medical GmbH, Hammelburg, Germany) was used with a nose clip and connected to an ultrasonic spirometer (SpiroScout, Ganshorn) via a PFT filter. Participants performed three tidal breaths followed by a maximal cough, repeated three times. | Device | Sit-Mouthpiece |
| Mouthpiece (Pulmosafe, Lemon Medical) with nose clipPeak cough flow measured in the standing position. Same device and procedure as Sit-Mouthpiece condition. | Device | Stand-Mouthpiece |
Primary outcome
Peak cough Flow (PCF)
Time frame: Day 1
PCF measurement in L/s
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Background: PubMed 16055882Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
- Background: PubMed 35123355Brennan M, McDonnell MJ, Duignan N, Gargoum F, Rutherford RM. The use of cough peak flow in the assessment of respiratory function in clinical practice- A narrative literature review. Respir Med. 2022 Mar;193:106740. doi: 10.1016/j.rmed.2022.106740. Epub 2022 Jan 15.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facial mask (V2 Mask™, Hans Rudolph) and Mouthpiece (Pulmosafe, Lemon Medical) with nose clip in people with Peak Cough Flow Measurement, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 8 Jun 2026. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak cough Flow (PCF) (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07631481, which also lists 2 linked publications.
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 8 Jun 2026.