Can live feedback and coaching improve the effectiveness of airway clearance treatments for children and young people with cystic fibrosis?
| ISRCTN | ISRCTN44783555 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44783555 |
| Integrated Research Application System (IRAS) | 350280 |
| Sponsor | UCL Great Ormond Street Institute of Child Health |
| Funders | Rosetrees Trust, Stoneygate Trust |
- Submission date
- 30/10/2026
- Registration date
- 30/10/2026
- Last edited
- 30/10/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Cystic fibrosis is an inherited condition that affects the lungs and other organs. Airway clearance treatments (chest physiotherapy) are recommended to help clear mucus from the lungs and maintain respiratory health. Previous research has shown that airway clearance treatments can improve lung function when they are performed using the recommended breathing technique. However, many children and young people do not perform these treatments in the most effective way.
This study aims to investigate whether a novel breathing sensor and mobile application providing real-time feedback and coaching can improve the quality of airway clearance treatments performed by children and young people with cystic fibrosis. The study will also assess the feasibility and acceptability of this technology and generate information to support a future larger clinical trial.
Who can participate?
Children and young people aged 6 to 16 years with a confirmed diagnosis of cystic fibrosis who are prescribed regular airway clearance treatment and attend Great Ormond Street Hospital for Children NHS Foundation Trust.
What does the study involve?
Participants take part in a 3-month study using the ImpACT4CF breathing sensor and mobile application during their usual airway clearance treatments at home. The sensor records breathing information during treatment sessions and transfers the data securely for analysis.
The study consists of six stages, during which participants experience different levels of feedback and coaching, ranging from monitoring alone to real-time feedback on breathing technique. Information collected by the sensor is used to assess the quality of airway clearance treatments and investigate whether feedback and coaching can help participants perform their treatments more effectively. Participants, parents and healthcare professionals are also asked to provide feedback on their experiences of using the system.
What are the possible benefits and risks of participating?
Participants may benefit from improved understanding of their airway clearance treatments and from the real-time feedback and coaching provided by the ImpACT4CF system. The information gained from this study may help improve airway clearance treatment support for children and young people with cystic fibrosis in the future.
The risks associated with participation are considered low. The study involves the use of a breathing sensor and mobile application during routine airway clearance treatments and does not require participants to change their prescribed clinical care.
Where is the study run from?
UCL Great Ormond Street Institute of Child Health (UK)
When is the study starting and how long is it expected to run for?
October 2025 to November 2026
Who is funding the study?
The study is funded by the Rosetrees Trust and the Stoneygate Trust (UK)
Who is the main contact?
Prof. Eleanor Main, e.main@ucl.ac.uk
Contact information
Public, Scientific, Principal investigator
UCL Great Ormond Street Institute of Child Health, 4th Floor, 30 Guilford Street
London
WC1N 1EH
United Kingdom
 ORCID ID |
0000-0002-9739-3167 |
|---|---|
| Phone | +44 (0)7932730909 |
| e.main@ucl.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Observational study design | Single-centre two-arm six-stage cohort pilot study with an interrupted time series design |
| Scientific title | ImpACT4CF: a pilot study of real-time feedback and coaching to improve airway clearance treatment quality in children and young people with cystic fibrosis |
| Study acronym | ImpACT4CF |
| Study objectives | To determine whether real-time feedback and coaching delivered through the ImpACT4CF sensor and mobile application can improve the quality of airway clearance treatments performed by children and young people with cystic fibrosis. |
| Ethics approval(s) |
Approved 21/07/2025, London - Riverside Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 (0)20 7104 8150; riverside.rec@hra.nhs.uk), ref: 25/LO/0517 |
| Health condition(s) or problem(s) studied | Cystic fibrosis |
| Methodology | Participants will use the ImpACT4CF breathing sensor and mobile application during their usual airway clearance treatments at home over a 3-month period. The study comprises six sequential stages with increasing feedback and coaching support. Participants will experience different modes of feedback, ranging from monitoring alone to real-time coaching. During one study stage, participants will be allocated to different feedback approaches for comparison. Airway clearance treatment quality will be measured throughout the study using data recorded by the sensor. Participant, parent and healthcare professional experiences will also be collected to assess feasibility and acceptability and to inform the design of a future larger trial. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Puffin (ImpACT4CF breathing sensor and mobile coaching application) |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 30/11/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 16 Years |
| Sex | All |
| Target sample size at registration | 36 |
| Total final enrolment | 36 |
| Key inclusion criteria | 1. Patients using a commonly available ACT device which is compatible with the clip fitting of the ImpACT4CF sensor (e.g., Acapella, Astratech PEP, Aerobika or Pari PEP) 2. Children and young people aged between 6 – 16 years 3. Currently under the care of Great Ormond Street Hospital CF Centre (GOSH-CF) 4. The participant or legally acceptable representative must be able to give informed consent |
| Key exclusion criteria | 1. Medical, cognitive or behavioural factors that would prevent completion of study procedures 2. Inability to perform airway clearance treatment independently or with usual family support |
| Date of first enrolment | 31/10/2025 |
| Date of final enrolment | 30/06/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Great Ormond Street
London
WC1N 3JH
United Kingdom
London
WC1N 3JH
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
30/11/2026: Study's existence confirmed by the HRA.
