Pulmonary FunctionNCT06629454

Digital Incentive Spirometry Adherence

A study testing Adherence to digital incentive spirometer in the postop period after major chest surgery. in people with Pulmonary Function and Incentive Spirometry, run by University of Pennsylvania at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Pulmonary Function, Incentive Spirometry, Patient Adherence
What is being tested?: Adherence to digital incentive spirometer in the postop period after major chest surgery.
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 6 sitesUnited States
Study dates: 27 Dec 2024to 31 Jul 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

There are no exclusions based on economic status, gender, race, or ethnicity. An individual who meets any of the following criteria will be excluded from participation in this study:
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.
Pregnant individuals due to low likelihood of meeting inclusion criteria 4. Licensed medical professionals on the clinical team will follow proper procedures in determining if the individual is consenting. Proper procedures entail doing all of the following: giving a patient adequate information concerning the study, providing adequate opportunity for the patient to consider all options, responding to the patient's questions, ensuring that the patient has comprehended this information, obtaining the patient's voluntary agreement to participate and, continuing to provide information as the patient or situation requires. There will be ample opportunity for the patient to ask questions. In the event that the patient is in a vulnerable population and unable to provide consent, they will not be eligible to participate in the study and thus will not be screened. If the individual is not able to provide informed consent or if consent is not certain due to impairments or other factors, they will not be considered for study participation. In the event that the patient is in a vulnerable population and unable to provide consent, they will not be eligible to participate in the study and thus will not be screened.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Penn Medicine Valley Forge
Berwyn, Pennsylvania, 19312
Penn Medicine Cherry Hill
Cherry Hill, New Jersey, 08003
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Penn Medicine University City
Philadelphia, Pennsylvania, 19104
Penn Thoracic Surgery Presbyterian
Philadelphia, Pennsylvania, 19104
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Digital Incentive Spirometer for Assessing Incentive Spirometry Adherence

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.

Read the detailed description

Incentive spirometry is frequently prescribed as a standard-of-care for patients post-surgery to reduce the risk of developing postoperative pulmonary complications associated with atelectasis. An incentive spirometer (IS) is a mechanical breathing device that assists with pulmonary rehabilitation through improving lung expansion by encouraging deep breathing. While performing incentive spirometry exercises is effective at lowering atelectasis severity, ventilation time, and pulmonary complication rates, patient adherence to performing exercises is very poor. Medical staff, due to time constraints, often cannot supervise all of their patients' entire incentive spirometry regimens (usually every 10-15 min during wakeful hours), contributing to low adherence and incorrect exercise completion. This is compounded by current incentive spirometers lacking a method for accurately collecting patient exercise and adherence data. The present study seeks to evaluate the effect of a digital IS that provides instruction signals and exercise reminders on patients' incentive spirometry adherence.

The objective of this study is to evaluate the effect of a digital IS that provides gentle auditory and haptic reminders and exercise guidance on patient adherence to incentive spirometry. Secondarily, this study will evaluate metrics relating to lung function to assess post-surgery lung recovery in patients using the digital IS.

Conditions: Pulmonary Function, Incentive Spirometry, Patient Adherence, Lung Resection, Thoracic Surgery
Being tested: Adherence to digital incentive spirometer in the postop period after major chest surgery.
Keywords: Incentive spirometer, Patient adherence, Digital incentive spirometer
Medical subject headings: Patient Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT06629454
Study group	Role	What they receive
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. Receives: Device: Adherence to digital incentive spirometer in the postop period after major chest surgery.

What is being measured

The primary outcome is the main question the study is designed to answer.

Incentive Spirometry Adherence (Breath Attempts Per Day)
Number of inspiratory breath attempts performed with the digital IS per day.
Measured: 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.
Measured: Till discharge or up to 7 days

Secondary outcomes (4)

Volume of Inspiratory Breaths Attempted With the Digital IS
Inspiratory volume in milliliters measured from one inhalation from the device
Measured: Till discharge or up to 7 days
Blood Oxygen Saturation
Average postoperative SpO2 per patient. Mean is the mean across the patient cohort.
Measured: Till discharge or up to 7 days
Pain Scores
Postoperative pain scores will be reported on a scale from 0 (no pain) to 10 (unbearable pain). These are then averaged per patient. Mean and range is reported for the entirely of the patient cohort.
Measured: Till discharge or up to 7 days
Flow Rate of Inspiratory Breaths Attempted From the Digital IS
Flow rate over time (mL/sec) of each inspiratory breath measured from one inhalation from the device.
Measured: Till discharge or up to 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Dec 202431 Jul 2025

First posted8 Oct 2024
Study start27 Dec 2024
Primary completion31 Jul 2025
Study completion31 Jul 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pulmonary FunctionStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe 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
Masking: None (open label)
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06629454
Sponsor's protocol ID: ebebfaib
Status last verified: Oct 2025
First submitted: 25 Sep 2024
Last updated: 20 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
RecruitingPhase 2
Study of REGN13335 in Adult Participants With Pulmonary Arterial Hypertension (PAH)
Pulmonary Arterial Hypertension (PAH)
Active, not recruitingPhase 3
Testing Cabozantinib in Patients With Advanced Pancreatic Neuroendocrine and Carcinoid Tumors
Functioning Pancreatic Neuroendocrine Tumor, Intermediate Grade Lung Neuroendocrine Neoplasm
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Not yet recruiting
Bedside Assessment of Right Ventricular Output Lying in Prone Or Supine
Right Ventricular Function, Prone Position

All Pulmonary Function trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Digital Incentive Spirometer for Assessing Incentive Spirometry Adherence
ClinicalTrials.gov ID: NCT06629454
Acronym / sponsor ID: ebebfaib
Conditions: Pulmonary Function, Incentive Spirometry, Patient Adherence, Lung Resection, Thoracic Surgery
Keywords: Incentive spirometer, Patient adherence, Digital incentive spirometer
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Study start: 27 Dec 2024 (actual)
Primary completion: 31 Jul 2025 (actual)
Study completion: 31 Jul 2025 (actual)
First posted: 8 Oct 2024 (actual)
Results: Posted 20 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Single arm proof of concept study of a digital incentive spirometer	Experimental	Device: Adherence to digital incentive spirometer in the postop period after major chest surgery.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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (5 listed)

There are no exclusions based on economic status, gender, race, or ethnicity. An individual who meets any of the following criteria will be excluded from participation in this study:
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.
Pregnant individuals due to low likelihood of meeting inclusion criteria 4. Licensed medical professionals on the clinical team will follow proper procedures in determining if the individual is consenting. Proper procedures entail doing all of the following: giving a patient adequate information concerning the study, providing adequate opportunity for the patient to consider all options, responding to the patient's questions, ensuring that the patient has comprehended this information, obtaining the patient's voluntary agreement to participate and, continuing to provide information as the patient or situation requires. There will be ample opportunity for the patient to ask questions. In the event that the patient is in a vulnerable population and unable to provide consent, they will not be eligible to participate in the study and thus will not be screened. If the individual is not able to provide informed consent or if consent is not certain due to impairments or other factors, they will not be considered for study participation. In the event that the patient is in a vulnerable population and unable to provide consent, they will not be eligible to participate in the study and thus will not be screened.

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
Adherence to digital incentive spirometer in the postop period after major chest surgery.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.	Device	Single arm proof of concept study of a digital incentive spirometer

Primary outcome

Incentive Spirometry Adherence (Breath Attempts Per Day)
Time frame: Till discharge or up to 7 days
Number of inspiratory breath attempts performed with the digital IS per day.
Incentive Spirometry Consistency (Hours Per Day With ≥1 Breath)
Time frame: Till discharge or up to 7 days
Number of hours in which at least one inspiratory breath was attempted using the digital IS per day.

4 secondary outcomes

Volume of Inspiratory Breaths Attempted With the Digital IS
Time frame: Till discharge or up to 7 days
Blood Oxygen Saturation
Time frame: Till discharge or up to 7 days
Pain Scores
Time frame: Till discharge or up to 7 days
Flow Rate of Inspiratory Breaths Attempted From the Digital IS
Time frame: Till discharge or up to 7 days

Results and safety

Results posted to the registry on 20 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single Arm Proof of Concept Study of a Digital Incentive Spirometer	31	30

Primary outcome: Incentive Spirometry Adherence (Breath Attempts Per Day)

Time frame: Till discharge or up to 7 days. Mean (Inter-Quartile Range). Unit: Breath attempts

Measure	Single Arm Proof of Concept Study of a Digital Incentive Spirometer n = 30
Value	45 (23 to 59)

Primary outcome: Incentive Spirometry Consistency (Hours Per Day With ≥1 Breath)

Time frame: Till discharge or up to 7 days. Mean (Inter-Quartile Range). Unit: Hours

Measure	Single Arm Proof of Concept Study of a Digital Incentive Spirometer n = 30
Value	7.6 (5.75 to 10)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Enrollment Until 4 Months After Discharge, up to 18 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single Arm Proof of Concept Study of a Digital Incentive Spirometer	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Limitations and caveats (from the sponsor): This was a single-arm, open-label study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Pulmonary Function

Not yet recruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
RecruitingPhase 2
Study of REGN13335 in Adult Participants With Pulmonary Arterial Hypertension (PAH)
Pulmonary Arterial Hypertension (PAH)
Active, not recruitingPhase 3
Testing Cabozantinib in Patients With Advanced Pancreatic Neuroendocrine and Carcinoid Tumors
Functioning Pancreatic Neuroendocrine Tumor, Intermediate Grade Lung Neuroendocrine Neoplasm
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Not yet recruiting
Bedside Assessment of Right Ventricular Output Lying in Prone Or Supine
Right Ventricular Function, Prone Position

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.

Doraid Jarrar, MD principal investigator

University of Pennsylvania

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 5 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 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. 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?

Yes. Results are posted in the registry (first posted 20 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Incentive Spirometry Adherence (Breath Attempts Per Day) (time frame: Till discharge or up to 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06629454.

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 20 Oct 2025.