Hearing ImpairmentNEATCAPNCT02744066
A Pilot Study to Evaluate Patient Tolerance and Nursing Ease-of-Use of a Novel Hearing Protection Device
A study testing NEATCAP in people with Hearing Impairment, run by Michael Balsan, MD at 1 site in United States.
Trial summary
Before they are born, babies are protected from hearing very loud noises by their mother's bodies. After delivery, they are exposed to many loud noises that are potentially harmful. These noises happen in the neonatal intensive care unit (NICU). Read more about this study
- Who is it for?
- Ages 12 hours to 2 weeks
- Conditions the study is for
- Hearing Impairment
- What is being tested?
- NEATCAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2017to 5 Oct 2017
- 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 12 hours to 2 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonate admitted to the Neonatal Intensive Care Unit
- Age greater than 12 hours and less than 2 weeks
- Informed consent from the parent(s)
Who cannot join
- Significant cranial trauma noted on admission
- Congenital anomalies of the head and/or neck
- Hemodynamic instability requiring pharmacologic intervention
- Recommendation by the attending neonatologist not to enroll the patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Evaluate Patient Tolerance and Nursing Ease-of-Use of a Novel Hearing Protection Device to Reduce Exposure to Excessive Noise Among Patients Undergoing Neonatal Intensive Care
Before they are born, babies are protected from hearing very loud noises by their mother's bodies. After delivery, they are exposed to many loud noises that are potentially harmful. These noises happen in the neonatal intensive care unit (NICU). The purpose of this research project is to test the fit and the ease-of-use of a new device that may protect infant's hearing in the NICU.
Read the detailed description
Despite the best efforts of Neonatal Intensive Care Unit (NICU) caregivers, vulnerable and fragile NICU patients are frequently exposed to noxious levels of noise from monitoring and respiratory equipment alarms, as well as from routine NICU care practices. Particularly detrimental to sleep and auditory development are patient exposures to high frequency noises that are specifically designed to alert NICU caregivers to important changes in patient status. This pilot study will help evaluate the fit, ergonomic design and the ease-of-use of a novel hearing protection system (special ear-muffs along with a unique attachment mechanism) specifically designed top diminish the transmission of high frequency noises to patients within the NICU, while allowing some transmission of low frequency sounds, such as a mother's voice.
- Conditions
- Hearing Impairment
- Being tested
- NEATCAP
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEATCAPDevice
Neonates will be sized and fitted to wear the non-invasive novel hearing protection device over a set period of time in the NICU. Vitals will be monitored.
| Study group | Role | What they receive |
|---|---|---|
| Neonates | Other | Neonates admitted to the NICU will be fitted for NEATCAP, non-invasive novel hearing protection device. Receives: Device: NEATCAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Skin Erythema After Device Application
Skin will be assessed for adverse effects such as any device-related adverse events, including evidence of skin redness, rash and/or bruising or discomfort at the site of device application. Skin erythema was described as none, mild, moderate or severe as evaluated by the NICU nursing staff.
Measured: Skin erythema was evaluated at the time of device removal after 1 hour of application in phase #1 and after 3 daily 8 hour periods of application in phase #2.
Secondary outcomes (1)
Number of Participants With Specific Responses to the Ease of Use Questionnaire for NICU Staff.
A >80% positive response to a multi-question Ease-of-Use Questionnaire completed by the participating NICU staff. Ease-of-Use Questionnaire constructed on a 5 point Likert Scale: 1 = Strongly Disagree, 2 = Disagree, 3 = Neutral, 4 = Agree, 5 = Strongly Agree that the device was easy-to-use. Phase #1 consists of 25 data points. Phase #2 consists of 25 data points. Evaluations were obtained after device removal in both phases.
Measured: After 1 hour in phase #1 / After 3 x 8 hours in phase #2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study start31 Jan 2017
- Primary completion5 Oct 2017
- Study completion5 Oct 2017
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hearing ImpairmentStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Balsan, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael Balsan, MD, University of Pittsburgh
- Investigators
- Michael J Balsan, MD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744066
- Sponsor's protocol ID
- PRO16010220
- Acronym
- NEATCAP
- Status last verified
- Nov 2018
- First submitted
- 14 Apr 2016
- Last updated
- 29 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Balsan MJ, Burns J, Kimock F, Hirsch E, Unger A, Telesco R, Bloch-Salisbury E. A pilot study to assess the safety, efficacy and ease of use of a novel hearing protection device for hospitalized neonates. Early Hum Dev. 2021 May;156:105365. doi: 10.1016/j.earlhumdev.2021.105365. Epub 2021 Mar 26.
PubMed 33857731
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate Patient Tolerance and Nursing Ease-of-Use of a Novel Hearing Protection Device to Reduce Exposure to Excessive Noise Among Patients Undergoing Neonatal Intensive Care
- ClinicalTrials.gov ID
- NCT02744066
- Acronym / sponsor ID
- NEATCAP / PRO16010220
- Conditions
- Hearing Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Michael Balsan, MDUniversity, hospital or other
- Study start
- 31 Jan 2017 (actual)
- Primary completion
- 5 Oct 2017 (actual)
- Study completion
- 5 Oct 2017 (actual)
- First posted
- 20 Apr 2016 (estimated)
- Results
- Posted 29 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Before they are born, babies are protected from hearing very loud noises by their mother's bodies. After delivery, they are exposed to many loud noises that are potentially harmful. These noises happen in the neonatal intensive care unit (NICU). The purpose of this research project is to test the fit and the ease-of-use of a new device that may protect infant's hearing in the NICU.
Detailed description
Despite the best efforts of Neonatal Intensive Care Unit (NICU) caregivers, vulnerable and fragile NICU patients are frequently exposed to noxious levels of noise from monitoring and respiratory equipment alarms, as well as from routine NICU care practices. Particularly detrimental to sleep and auditory development are patient exposures to high frequency noises that are specifically designed to alert NICU caregivers to important changes in patient status. This pilot study will help evaluate the fit, ergonomic design and the ease-of-use of a novel hearing protection system (special ear-muffs along with a unique attachment mechanism) specifically designed top diminish the transmission of high frequency noises to patients within the NICU, while allowing some transmission of low frequency sounds, such as a mother's voice.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neonates | Other | Device: NEATCAPNeonates admitted to the NICU will be fitted for NEATCAP, non-invasive novel hearing protection device. |
Who may qualify
- Ages
- 12 hours to 2 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Neonate admitted to the Neonatal Intensive Care Unit
- Age greater than 12 hours and less than 2 weeks
- Informed consent from the parent(s)
Key exclusion criteria (4 listed)
- Significant cranial trauma noted on admission
- Congenital anomalies of the head and/or neck
- Hemodynamic instability requiring pharmacologic intervention
- Recommendation by the attending neonatologist not to enroll the patient
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 |
|---|---|---|
| NEATCAPNeonates will be sized and fitted to wear the non-invasive novel hearing protection device over a set period of time in the NICU. Vitals will be monitored. | Device | Neonates |
Primary outcome
Number of Participants With Skin Erythema After Device Application
Time frame: Skin erythema was evaluated at the time of device removal after 1 hour of application in phase #1 and after 3 daily 8 hour periods of application in phase #2.
Skin will be assessed for adverse effects such as any device-related adverse events, including evidence of skin redness, rash and/or bruising or discomfort at the site of device application. Skin erythema was described as none, mild, moderate or severe as evaluated by the NICU nursing staff.
1 secondary outcome
Number of Participants With Specific Responses to the Ease of Use Questionnaire for NICU Staff.
Time frame: After 1 hour in phase #1 / After 3 x 8 hours in phase #2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33857731Balsan MJ, Burns J, Kimock F, Hirsch E, Unger A, Telesco R, Bloch-Salisbury E. A pilot study to assess the safety, efficacy and ease of use of a novel hearing protection device for hospitalized neonates. Early Hum Dev. 2021 May;156:105365. doi: 10.1016/j.earlhumdev.2021.105365. Epub 2021 Mar 26.
- Individual participant dataSharing planned: Undecided
Related trials for Hearing Impairment
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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.
Michael J Balsan, MD principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NEATCAP in people with Hearing Impairment, run by Michael Balsan, MD 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 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 29 Nov 2018. 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?
Yes. Results are posted in the registry (first posted 29 Nov 2018). 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?
Number of Participants With Skin Erythema After Device Application (time frame: Skin erythema was evaluated at the time of device removal after 1 hour of application in phase #1 and after 3 daily 8 hour periods of application in phase #2.). 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 NCT02744066, which also lists 1 linked publication.
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 29 Nov 2018.