Otitis MediaWispr 2NCT07328555
Digital Otoscopy Versus Standard Otoscopy on the Diagnosis and Treatment of Otitis Media in Young Children
A study testing Device: Digital Otoscope in people with Otitis Media and Antimicrobial Stewardship, run by Boston Children's Hospital at 1 site in United States.
Trial summary
Randomized controlled trial involving 4 pediatric primary care practices in Massachusetts. Practices will be stratified by their OM diagnosis and treatment rate, with two practices randomly assigned to the intervention arm and two to the control arm. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Otitis Media, Antimicrobial Stewardship
- What is being tested?
- Device: Digital Otoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- PPOC practices with 4-9 patient exam rooms, willing to commit to using digital otoscopy for 6 months.
- Not currently using digital otoscopy.
- Not involved in the network's previous digital otoscopy study
Who cannot join
- Currently using any digital otoscope
Trial locations and contacts
1 site in 1 country.
United States1 site
Pediatric Physicians' Organization at Children's
Wellesley, Massachusetts, 02481
About this study
Official title: Site Randomized Clinical Trial of the Effect of Digital Otoscopy Versus Standard Otoscopy on the Diagnosis and Treatment of Otitis Media in Young Children
Randomized controlled trial involving 4 pediatric primary care practices in Massachusetts. Practices will be stratified by their OM diagnosis and treatment rate, with two practices randomly assigned to the intervention arm and two to the control arm.
For practices randomized to the intervention arm, their offices will be equipped with digital otoscopes (Wispr Digital Otoscope, WiscMed) in each exam room in place of traditional otoscopes. Clinicians in intervention practices will attend a two-hour initial training session on the use of digital otoscopy followed by two one-hour follow-up sessions held over a two-month run-in period prior to the study start to review best practices and troubleshoot any difficulties adapting to the new technology.
Read more
Upon completion of the run-in training period, a six-month data collection period will begin. The primary outcome will consist of a difference-in-difference analysis comparing the difference in the OM Treatment Index (OMTI) from the baseline period (October 1 through March 31, 2025) to the intervention period (October 1 through March 31, 2026) between the intervention practices and the control practices. The OMTI is a measure of the rate of diagnosis and antibiotic treatment of OM, specifically calculated as the number of cases with an OM diagnosis and systemic antibiotic prescribed divided by the number of visits with a diagnosis of any acute respiratory tract illness.
Secondary outcomes include analogous difference-in-difference comparisons of: 1) overall antibiotic courses prescribed; 2) overall days of antibiotics prescribed; and 3) a balancing measure of the rate of return visits with any acute respiratory tract illness diagnosis within 7 days of an index visit. Additionally, clinicians will be surveyed to assess confidence and satisfaction in diagnosing OM and preference for digital versus traditional otoscopy.
To incentivize participation, practices randomized to the control arm will be loaned digital otoscopes to use for six months at the conclusion of the clinical trial.
- Conditions
- Otitis Media, Antimicrobial Stewardship
- Being tested
- Device: Digital Otoscope
- Keywords
- Otoscopy
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: Digital OtoscopeDevice
Use of the Wispr digital otoscope to diagnose otitis media in place of a standard visual otoscope
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Digital Otoscopy | Experimental | Use of the Wispr digital otoscope to diagnose otitis media in place of a traditional visual otoscope Receives: Device: Device: Digital Otoscope |
| No intervention: Control | No intervention | No intervention - standard otoscopy to be used |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in proportion of visits with any respiratory diagnosis in which otitis media is diagnosed and treated with antibiotics (referred to as the otitis media treatment index - OMTI).
Difference-in-differences analysis of the change in OMTI from baseline to the intervention period comparing the intervention arm to the control arm using logistic regression with nested random effect at the practice level.
Measured: 6 months
Secondary outcomes (3)
Change in overall antibiotic courses prescribed
Difference-in-differences analysis of the change in the overall number of antibiotic courses prescribed per 100 encounters (excluding well visits) comparing the intervention arm to the control arm, using logistic regression with nested random effect at the practice level.
Measured: 6 months
Change in overall prescribed antibiotic days
Difference-in-differences analysis of the change in the overall number of prescribed antibiotic days per 100 encounters (excluding well visits) comparing the intervention arm to the control arm, using logistic regression with nested random effect at the practice level.
Measured: 6 months
Return acute respiratory tract illness visits
Comparison between intervention and control arm of the proportion of patients with an index visit with an acute respiratory tract illness diagnosis who return to the PCP for a visit with an acute respiratory tract illness diagnosis within 7 days of index
Measured: Within 7 days of index visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start1 Mar 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otitis MediaStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Four enrolled practices: * Two will receive the intervention (digital otoscopy) * Two will not receive an intervention (control)
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jon Hatoun, Boston Children's Hospital
- Investigators
- Louis Vernacchio, MD, MSc, Study director, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07328555
- Sponsor's protocol ID
- PPOC_Wispr 2
- Acronym
- Wispr 2
- Status last verified
- May 2026
- First submitted
- 7 Jan 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Electronic health record data use for the study are property of the individual practices and may not be shard publicly without their expressed permission.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Site Randomized Clinical Trial of the Effect of Digital Otoscopy Versus Standard Otoscopy on the Diagnosis and Treatment of Otitis Media in Young Children
- ClinicalTrials.gov ID
- NCT07328555
- Acronym / sponsor ID
- Wispr 2 / PPOC_Wispr 2
- Conditions
- Otitis Media, Antimicrobial Stewardship
- Keywords
- Otoscopy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 9 Jan 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.
Randomized controlled trial involving 4 pediatric primary care practices in Massachusetts. Practices will be stratified by their OM diagnosis and treatment rate, with two practices randomly assigned to the intervention arm and two to the control arm.
For practices randomized to the intervention arm, their offices will be equipped with digital otoscopes (Wispr Digital Otoscope, WiscMed) in each exam room in place of traditional otoscopes. Clinicians in intervention practices will attend a two-hour initial training session on the use of digital otoscopy followed by two one-hour follow-up sessions held over a two-month run-in period prior to the study start to review best practices and troubleshoot any difficulties adapting to the new technology.
Upon completion of the run-in training period, a six-month data collection period will begin. The primary outcome will consist of a difference-in-difference analysis comparing the difference in the OM Treatment Index (OMTI) from the baseline period (October 1 through March 31, 2025) to the intervention period (October 1 through March 31, 2026) between the intervention practices and the control practices. The OMTI is a measure of the rate of diagnosis and antibiotic treatment of OM, specifically calculated as the number of cases with an OM diagnosis and systemic antibiotic prescribed divided by the number of visits with a diagnosis of any acute respiratory tract illness.
Secondary outcomes include analogous difference-in-difference comparisons of: 1) overall antibiotic courses prescribed; 2) overall days of antibiotics prescribed; and 3) a balancing measure of the rate of return visits with any acute respiratory tract illness diagnosis within 7 days of an index visit. Additionally, clinicians will be surveyed to assess confidence and satisfaction in diagnosing OM and preference for digital versus traditional otoscopy.
To incentivize participation, practices randomized to the control arm will be loaned digital otoscopes to use for six months at the conclusion of the clinical trial.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Four enrolled practices: * Two will receive the intervention (digital otoscopy) * Two will not receive an intervention (control)
| Arm | Type | Receives |
|---|---|---|
| Experimental: Digital Otoscopy | Experimental | Device: Device: Digital OtoscopeUse of the Wispr digital otoscope to diagnose otitis media in place of a traditional visual otoscope |
| No intervention: Control | No intervention | –No intervention - standard otoscopy to be used |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- PPOC practices with 4-9 patient exam rooms, willing to commit to using digital otoscopy for 6 months.
- Not currently using digital otoscopy.
- Not involved in the network's previous digital otoscopy study
Key exclusion criteria (1 listed)
- Currently using any digital otoscope
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 |
|---|---|---|
| Device: Digital OtoscopeUse of the Wispr digital otoscope to diagnose otitis media in place of a standard visual otoscope | Device | Experimental: Digital Otoscopy |
Primary outcome
Change in proportion of visits with any respiratory diagnosis in which otitis media is diagnosed and treated with antibiotics (referred to as the otitis media treatment index - OMTI).
Time frame: 6 months
Difference-in-differences analysis of the change in OMTI from baseline to the intervention period comparing the intervention arm to the control arm using logistic regression with nested random effect at the practice level.
3 secondary outcomes
Change in overall antibiotic courses prescribed
Time frame: 6 months
Change in overall prescribed antibiotic days
Time frame: 6 months
Return acute respiratory tract illness visits
Time frame: Within 7 days of index visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No. Electronic health record data use for the study are property of the individual practices and may not be shard publicly without their expressed permission.
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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.
Louis Vernacchio, MD, MSc study director
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device: Digital Otoscope in people with Otitis Media and Antimicrobial Stewardship, run by Boston Children's Hospital at 1 site in United States.
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 3 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 22 May 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 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?
This study is still under way. Results are not available in the source record yet.
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 in proportion of visits with any respiratory diagnosis in which otitis media is diagnosed and treated with antibiotics (referred to as the otitis media treatment index - OMTI). (time frame: 6 months). 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 22 May 2026.