Effect of Digital Incentive Spirometry Training in Healthy Adults

NCT07528222 | Completed

• 1 other identifier: N202404134
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. Participants completed a 3-week training period with app-recorded adherence and were assessed before and after the intervention.

Conditions

Respiratory Function; Pulmonary Function; Respiratory Muscle Strength

Keywords

Incentive Spirometry; Digital Incentive Spirometry; Respiratory Training; Pulmonary Function; Healthy Adults; TryBreath; Mobile Health; Telemonitoring

Outcome Measures

Primary Outcomes (3)

• Change from baseline in forced expiratory volume in 1 second (FEV1)

  FEV1 measured before and after the intervention.

  Baseline and post-intervention at 3 weeks

• Change from baseline in Forced Vital Capacity (FVC)

  FVC measured before and after the intervention.

  Baseline and post-intervention at 3 weeks

• Change from baseline in Peak Expiratory Flow (PEF)

  PEF measured before and after the intervention.

  Baseline and post-intervention at 3 weeks

Secondary Outcomes (5)

• Change from baseline in Maximal Inspiratory Pressure (MIP)

  Baseline and post-intervention at 3 weeks

• Change from baseline in Maximal Expiratory Pressure (MEP)

  Baseline and post-intervention at 3 weeks

• Change from baseline in 2-Minute Step Test Performance

  Baseline and post-intervention at 3 weeks

• Change from baseline in Borg Dyspnea Scale score.

  Baseline and post-intervention at 3 weeks

• Change from baseline in Numeric Rating Scale (NRS) for muscle discomfort.

  Baseline and post-intervention at 3 weeks

Study Arms (1)

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.

Device: TryBreath Digital Incentive Spirometry System

Interventions

TryBreath Digital Incentive Spirometry System DEVICE

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.

Digital Incentive Spirometry Training

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Medical University: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

Taipei Medical University, Taipei, Taiwan

Taipei, 11031, Taiwan

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: All participants received the same digital incentive spirometry intervention and were evaluated before and after the intervention.

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 14, 2026
• Study Start: May 22, 2024
• Primary Completion: December 26, 2024
• Study Completion: January 9, 2025
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)