Respiratory FunctionNCT07528222
Effect of Digital Incentive Spirometry Training in Healthy Adults
A study testing TryBreath Digital Incentive Spirometry System in people with Respiratory Function and Pulmonary Function, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
This prospective single-group pre-post study evaluated whether digital incentive spirometry training using the TryBreath system could improve pulmonary function, respiratory muscle strength, exercise capacity, and symptom scores in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Function, Pulmonary Function, Respiratory Muscle Strength
- What is being tested?
- TryBreath Digital Incentive Spirometry System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 May 2024to 9 Jan 2025
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged 18 to 45 years
- FEV1/FVC greater than 70% on pulmonary function testing
- Not currently participating in another research study
- Able and willing to provide informed consent
Who cannot join
- EV1/FVC less than 70% on pulmonary function testing
- History of thoracic or pulmonary disease, including pneumothorax, lung cancer, or prior thoracic surgery
- Acute exacerbation of asthma, chronic bronchitis, or chronic obstructive pulmonary disease within the previous 3 months
- Unable to comply with study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Digital Incentive Spirometry Training on Pulmonary Function and Respiratory Muscle Strength in Healthy Adults: A Prospective Single-Group Pre-Post Study
This prospective single-group pre-post study evaluated whether digital incentive spirometry training using the TryBreath system could improve pulmonary function, respiratory muscle strength, exercise capacity, and symptom scores in healthy adults. Participants completed a 3-week training period with app-recorded adherence and were assessed before and after the intervention.
Read the detailed description
This prospective single-group pre-post study investigated the effects of digital incentive spirometry training in healthy adults. Participants were recruited at Taipei Medical University and received training using the TryBreath digital incentive spirometry system, which integrates an incentive spirometer with infrared sensing, ultrasonic wireless data transmission, and a mobile application for real-time feedback and adherence tracking.
Participants completed a 3-week intervention period. The target training dose was at least 30 sustained inspirations per day, and at least 10 compliant training days were required for protocol adherence. Pulmonary function, respiratory muscle strength, exercise capacity, and symptom scores were assessed before and after the intervention.
Outcome measures included forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), peak expiratory flow (PEF), maximal inspiratory pressure (MIP), maximal expiratory pressure (MEP), 2-minute step test performance, Borg breathlessness score, and numerical rating scale (NRS) muscle discomfort score.
- Being tested
- TryBreath Digital Incentive Spirometry System
- Keywords
- Incentive Spirometry, Digital Incentive Spirometry, Respiratory Training, Pulmonary Function, Healthy Adults, TryBreath, Mobile Health, Telemonitoring
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TryBreath Digital Incentive Spirometry SystemDevice
A digital incentive spirometer integrated with infrared sensing and ultrasonic wireless data transmission, connected to a mobile application that records inspiratory training sessions and provides real-time feedback.
| Study group | Role | What they receive |
|---|---|---|
| Digital Incentive Spirometry Training | Experimental | Participants received digital incentive spirometry training using the TryBreath system during a 3-week intervention period. The target training dose was at least 30 sustained inspirations per day, and adherence was tracked through a mobile application. Receives: Device: TryBreath Digital Incentive Spirometry System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in forced expiratory volume in 1 second (FEV1)
FEV1 measured before and after the intervention.
Measured: Baseline and post-intervention at 3 weeks
Change from baseline in Forced Vital Capacity (FVC)
FVC measured before and after the intervention.
Measured: Baseline and post-intervention at 3 weeks
Change from baseline in Peak Expiratory Flow (PEF)
PEF measured before and after the intervention.
Measured: Baseline and post-intervention at 3 weeks
Secondary outcomes (5)
Change from baseline in Maximal Inspiratory Pressure (MIP)
MIP measured before and after the intervention.
Measured: Baseline and post-intervention at 3 weeks
Change from baseline in Maximal Expiratory Pressure (MEP)
MEP measured before and after the intervention.
Measured: Baseline and post-intervention at 3 weeks
Change from baseline in 2-Minute Step Test Performance
Difference in 2-Minute Step Test Performance between baseline and post-intervention assessment.
Measured: Baseline and post-intervention at 3 weeks
Change from baseline in Borg Dyspnea Scale score.
Difference in Borg score between baseline and post-intervention assessment. The Borg Dyspnea Scale ranges from 0 to 10, where 0 indicates no breathlessness and 10 indicates maximal breathlessness. Higher scores indicate worse breathlessness.
Measured: Baseline and post-intervention at 3 weeks
Change from baseline in Numeric Rating Scale (NRS) for muscle discomfort.
Difference in NRS score between baseline and post-intervention assessment. The NRS ranges from 0 to 10, where 0 indicates no discomfort and 10 indicates worst possible discomfort. Higher scores indicate greater muscle discomfort.
Measured: Baseline and post-intervention at 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start22 May 2024
- Primary completion26 Dec 2024
- Study completion9 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FunctionStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants received the same digital incentive spirometry intervention and were evaluated before and after the intervention.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Principal investigator, Shu-Chuan Ho, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07528222
- Sponsor's protocol ID
- N202404134
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available because the dataset may contain potentially identifiable participant-level information and proprietary device-related records. Deidentified data may be available from the corresponding author upon reasonable request and subject to institutional review and applicable data-sharing regulations.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Digital Incentive Spirometry Training on Pulmonary Function and Respiratory Muscle Strength in Healthy Adults: A Prospective Single-Group Pre-Post Study
- ClinicalTrials.gov ID
- NCT07528222
- Acronym / sponsor ID
- N202404134
- Keywords
- Incentive Spirometry, Digital Incentive Spirometry, Respiratory Training, Pulmonary Function, Healthy Adults, TryBreath, Mobile Health, Telemonitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- 22 May 2024 (actual)
- Primary completion
- 26 Dec 2024 (actual)
- Study completion
- 9 Jan 2025 (actual)
- First posted
- 14 Apr 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.
This prospective single-group pre-post study evaluated whether digital incentive spirometry training using the TryBreath system could improve pulmonary function, respiratory muscle strength, exercise capacity, and symptom scores in healthy adults. Participants completed a 3-week training period with app-recorded adherence and were assessed before and after the intervention.
Detailed description
This prospective single-group pre-post study investigated the effects of digital incentive spirometry training in healthy adults. Participants were recruited at Taipei Medical University and received training using the TryBreath digital incentive spirometry system, which integrates an incentive spirometer with infrared sensing, ultrasonic wireless data transmission, and a mobile application for real-time feedback and adherence tracking.
Participants completed a 3-week intervention period. The target training dose was at least 30 sustained inspirations per day, and at least 10 compliant training days were required for protocol adherence. Pulmonary function, respiratory muscle strength, exercise capacity, and symptom scores were assessed before and after the intervention.
Outcome measures included forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), peak expiratory flow (PEF), maximal inspiratory pressure (MIP), maximal expiratory pressure (MEP), 2-minute step test performance, Borg breathlessness score, and numerical rating scale (NRS) muscle discomfort score.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants received the same digital incentive spirometry intervention and were evaluated before and after the intervention.
| Arm | Type | Receives |
|---|---|---|
| Digital Incentive Spirometry Training | Experimental | Device: TryBreath Digital Incentive Spirometry SystemParticipants received digital incentive spirometry training using the TryBreath system during a 3-week intervention period. The target training dose was at least 30 sustained inspirations per day, and adherence was tracked through a mobile application. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adults aged 18 to 45 years
- FEV1/FVC greater than 70% on pulmonary function testing
- Not currently participating in another research study
- Able and willing to provide informed consent
Key exclusion criteria (4 listed)
- EV1/FVC less than 70% on pulmonary function testing
- History of thoracic or pulmonary disease, including pneumothorax, lung cancer, or prior thoracic surgery
- Acute exacerbation of asthma, chronic bronchitis, or chronic obstructive pulmonary disease within the previous 3 months
- Unable to comply with study procedures
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 |
|---|---|---|
| TryBreath Digital Incentive Spirometry SystemA digital incentive spirometer integrated with infrared sensing and ultrasonic wireless data transmission, connected to a mobile application that records inspiratory training sessions and provides real-time feedback. | Device | Digital Incentive Spirometry Training |
Primary outcome
Change from baseline in forced expiratory volume in 1 second (FEV1)
Time frame: Baseline and post-intervention at 3 weeks
FEV1 measured before and after the intervention.
Change from baseline in Forced Vital Capacity (FVC)
Time frame: Baseline and post-intervention at 3 weeks
FVC measured before and after the intervention.
Change from baseline in Peak Expiratory Flow (PEF)
Time frame: Baseline and post-intervention at 3 weeks
PEF measured before and after the intervention.
5 secondary outcomes
Change from baseline in Maximal Inspiratory Pressure (MIP)
Time frame: Baseline and post-intervention at 3 weeks
Change from baseline in Maximal Expiratory Pressure (MEP)
Time frame: Baseline and post-intervention at 3 weeks
Change from baseline in 2-Minute Step Test Performance
Time frame: Baseline and post-intervention at 3 weeks
Change from baseline in Borg Dyspnea Scale score.
Time frame: Baseline and post-intervention at 3 weeks
Change from baseline in Numeric Rating Scale (NRS) for muscle discomfort.
Time frame: Baseline and post-intervention at 3 weeks
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 17 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available because the dataset may contain potentially identifiable participant-level information and proprietary device-related records. Deidentified data may be available from the corresponding author upon reasonable request and subject to institutional review and applicable data-sharing regulations.
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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.
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 TryBreath Digital Incentive Spirometry System in people with Respiratory Function and Pulmonary Function, run by Taipei Medical University at 1 site in Taiwan.
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 17 Apr 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 Taiwan. 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?
Change from baseline in forced expiratory volume in 1 second (FEV1) (time frame: Baseline and post-intervention at 3 weeks). The study lists 3 primary outcomes in all. 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 17 Apr 2026.