NCT07631481

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed
Last Updated

June 8, 2026

Status Verified

June 1, 2026

Enrollment Period

4 months

First QC Date

May 21, 2026

Last Update Submit

June 1, 2026

Conditions

Peak Cough Flow Measurement

Keywords

peak cough flowcoughinterfacespostures

Outcome Measures

Primary Outcomes (1)

  • Peak cough Flow (PCF)

    PCF measurement in L/s

    Day 1

Study Arms (4)

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

Interventions

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.

Sit-Mask
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.

Sit-Mouthpiece

Eligibility Criteria

Age20 Years - 30 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsSame number for each gender
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults aged 20 to 30 years
  • Non-smoker
  • Self-reported good health status
  • Able to perform all four randomized cough conditions

You may not qualify if:

  • Any chronic disease
  • Signs of airway obstruction on clinical examination
  • Auscultatory abnormalities (wheezing or stridor) prior to testing
  • Incomplete participation in all four conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1180, Belgium

Location

Related Publications (2)

  • 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.

    PMID: 16055882BACKGROUND

  • Brennan 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.

    PMID: 35123355BACKGROUND

MeSH Terms

Conditions

Cough

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT, PhD

Study Record Dates

First Submitted

May 21, 2026

First Posted

June 8, 2026

Study Start

May 1, 2024

Primary Completion

August 31, 2024

Study Completion

May 21, 2026

Last Updated

June 8, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)