Digital Incentive Spirometry Adherence

NCT06629454 | Completed Results FDA Device

• 1 other identifier: ebebfaib
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 6

Brief Summary

This single-arm proof-of-concept research study aims to assess the effect of a digital incentive spirometer (IS) device and a companion mobile-based app on incentive spirometry adherence in patients post-surgery. The digital IS utilizes a sensor to measure inspiratory breaths, and these data are transmitted wirelessly to a secure cloud database. The spirometer and app include a patient reminder system, exercise gamification strategies, progress tracking, and additional features designed to promote patient IS use.

Conditions

Pulmonary Function; Incentive Spirometry; Patient Adherence; Lung Resection; Thoracic Surgery

Keywords

Incentive spirometer; Patient adherence; Digital incentive spirometer

Outcome Measures

Primary Outcomes (2)

• Incentive Spirometry Adherence (Breath Attempts Per Day)

  Number of inspiratory breath attempts performed with the digital IS per day.

  Till discharge or up to 7 days

• Incentive Spirometry Consistency (Hours Per Day With ≥1 Breath)

  Number of hours in which at least one inspiratory breath was attempted using the digital IS per day.

  Till discharge or up to 7 days

Secondary Outcomes (4)

• Volume of Inspiratory Breaths Attempted With the Digital IS

  Till discharge or up to 7 days

• Blood Oxygen Saturation

  Till discharge or up to 7 days

• Pain Scores

  Till discharge or up to 7 days

• Flow Rate of Inspiratory Breaths Attempted From the Digital IS

  Till discharge or up to 7 days

Other Outcomes (12)

• Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO)

  up to 2 weeks before the surgery

• Forced Expiratory Volume in 1 Second (FEV-1)

  up to 2 weeks before the surgery

• Forced Vital Capacity (FVC)

  up to 2 weeks before the surgery

Study Arms (1)

Single arm proof of concept study of a digital incentive spirometer

EXPERIMENTAL

This single-arm proof-of-concept research study aims to assess the effect of a digital incentive spirometer (IS) device and a companion mobile-based app on incentive spirometry adherence in patients post-surgery. The digital IS utilizes a sensor to measure inspiratory breaths, and these data are transmitted wirelessly to a secure cloud database. The spirometer and app include a patient reminder system, exercise gamification strategies, progress tracking, and additional features designed to promote patient IS use.

Device: Adherence to digital incentive spirometer in the postop period after major chest surgery.

Interventions

Adherence to digital incentive spirometer in the postop period after major chest surgery. DEVICE

Major chest surgery can lead to respiratory compromise and traditional breathing exercises are not supervised or monitored. The primary objective of this study is to evaluate the effect of a multifeatured digital IS and integrated phone app on patient adherence to incentive spirometry. Together the device and app will include the following functions: an auditory and haptic reminder cue, visual and auditory cues to guide exercise completion, exercise gamification, and data tracking and visualization features.

Single arm proof of concept study of a digital incentive spirometer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, 18 years or older.
• Undergoes any anatomic lung resection surgery
• An incentive spirometer is expected to be ordered for the patient as standard-of-care
• There is no restriction on active medications.

You may not qualify if:

• Vulnerable populations who in the opinion of the investigator are unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy.
• History of prior non-compliance to prescribed therapy or presence or history of significant psychiatric condition (e.g., drug or alcohol addiction, psychosis, schizophrenia), or cognitive issue which would in the opinion of the investigator, make it difficult for the patient to comply with the study procedures or follow the investigators instructions.
• Populations for whom in the opinion of the investigator, incentive spirometry is deemed inappropriate due to medical condition or otherwise.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (6)

Penn Medicine Cherry Hill

Cherry Hill, New Jersey, 08003, United States

Location

Penn Medicine Valley Forge

Berwyn, Pennsylvania, 19312, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Penn Medicine University City

Philadelphia, Pennsylvania, 19104, United States

Location

Penn Thoracic Surgery Presbyterian

Philadelphia, Pennsylvania, 19104, United States

Location

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Limitations and Caveats

This was a single-arm, open-label study.

Results Point of Contact

• Title: Doraid Jarrar
• Organization: University of Pennsylvania

doraid.jarrar@pennmedicine.upenn.edu

2156627878

Study Officials

• Doraid Jarrar, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: October 8, 2024
• Study Start: December 27, 2024
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: October 20, 2025
• Results First Posted: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)