Hearing LossNCT03309553
Reducing Childhood Hearing Loss in an Alaska Native Population Through a New School Screening and Referral Process That Utilizes Mobile Health and Telemedicine
A study testing Current Primary Care Referral Process and Telemedicine Referral Process in people with Hearing Loss, run by Norton Sound Health Corporation at 1 site in United States.
Trial summary
Hearing loss is a common health problem in Alaska. Up to 75% of children growing up in Alaskan villages experience frequent ear infections, one of the major treatable causes of hearing loss. Children with even mild hearing loss face many challenges. Read more about this study
- Who is it for?
- Ages 4 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Current Primary Care Referral Process and Telemedicine Referral Process
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,481 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2017to 21 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 4 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Student of the Bering Strait School District (BSSD) in Alaska
- All school-aged children, from Kindergarten through 12th grade in the school district are eligible to participate
- Parental signed consent to undergo routine hearing screening in the school setting
- Verbal assent from children enrolled in the study
Who cannot join
- Not a student of the Bering Strait School District
- Parental consent for routine hearing screening not obtained
- Verbal assent not obtained
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hearing Norton Sound: A Community Randomized Trial to Address Childhood Hearing Loss in Rural Alaska
Hearing loss is a common health problem in Alaska. Up to 75% of children growing up in Alaskan villages experience frequent ear infections, one of the major treatable causes of hearing loss. Children with even mild hearing loss face many challenges. These children often experience speech and language delays and have trouble in school. Teens with hearing loss are more likely to drop out of school, and are at risk for having difficulty finding jobs as adults. Promptly diagnosing and treating hearing loss is important for preventing these consequences. Alaska mandates school-based hearing screening, but many children with hearing loss are not identified by the current screening protocol, and most who are referred never make it into the healthcare system for diagnosis and treatment.
Alaska has already developed innovative strategies to address hearing loss. A network of village health clinics staffed by community health aides provide local care, and telemedicine has been adopted in over 250 village clinics statewide. Despite being widely available, telemedicine has not yet been used in school hearing screenings to speed up the referral process.
Norton Sound Health Corporation has partnered with Duke and Johns Hopkins Universities to explore whether a new school screening and referral process that incorporates mobile, or mHealth, screening and telemedicine referral will reduce childhood hearing loss disparities in the Norton Sound region. Children from kindergarten through 12th grade in 15 Norton Sound villages will receive the current school screening protocol and the new mHealth screen. Villages will then be randomized to continue the current primary care referral process or to adopt telemedicine referral for school screenings. The investigators hypothesize that the new mHealth screening protocol will identify more children with hearing loss, and telemedicine referral will reduce time to diagnosis. By better identifying hearing loss and speeding up diagnosis and treatment, the investigators expect the burden of childhood hearing loss to drop, hearing-related quality of life to improve, and school performance to improve in villages with telemedicine referral compared to current primary care referral villages. If the study shows these positive effects, mHealth screening and the telemedicine referral process could be implemented in school districts across the state of Alaska to reducing childhood hearing loss disparities statewide.
- Conditions
- Hearing Loss
- Being tested
- Current Primary Care Referral Process, Telemedicine Referral Process
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Current Primary Care Referral ProcessOther
Children who screen positive for hearing loss will receive the same method each school had been using previously. This process involves a letter home to the parents, either sent with the child or by mail, requesting that the parent/caregiver bring the child to village health clinic for an evaluation.
Telemedicine Referral ProcessOther
In villages randomized to the expedited telemedicine intervention, parents of children who screen positive will receive a phone call from the school or the clinic on the day of screening notifying them of the day and time of their child's telemedicine consultation appointment. Appointments will be made same-day or next-day, with community health aides (CHAs) who have dedicated time blocked off to perform telemedicine consults. Participating children screening positive will be transported to clinic for their appointment with adult chaperones. Parents are encouraged but not required to attend, except for children grades 2 and younger, for whom parental participation will be required. Nonparticipating children in communities assigned to the expedited telemedicine intervention arm will receive standard referral following the current school primary care referral process.
| Study group | Role | What they receive |
|---|---|---|
| Current Primary Care Referral Process | Active comparator | In villages randomized to the current primary care process, families will be notified if their children screen positive in exactly the same method each school had been using previously. This process involves a letter home to the parents, either sent with the child or by mail, requesting that the parent/caregiver bring the child to village health clinic for an evaluation. The list of referred children is also given to the Norton Sound Audiology Department, who reaches out to families to schedule appointments during the next available audiology clinic. Receives: Other: Current Primary Care Referral Process |
| Expedited Telemedicine Referral | Experimental | In villages randomized to the expedited telemedicine intervention, parents of children who screen positive will receive a phone call from the school or the clinic on the day of screening notifying them of the day and time of their child's telemedicine consultation appointment. Appointments will be made same-day or next-day, with community health aides (CHAs) who have dedicated time blocked off to perform telemedicine consults. Participating children screening positive will be transported to clinic for their appointment with adult chaperones. Parents are encouraged but not required to attend, except for children grades 2 and younger, for whom parental participation will be required. Nonparticipating children in communities assigned to the expedited telemedicine intervention arm will receive standard referral following the current school primary care referral process. Receives: Other: Telemedicine Referral Process |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to diagnosis
Comparing time to International Classification of Disease, Tenth Edition (ICD-10) ear/hearing diagnosis from date of screening between intervention and active comparator
Measured: From date of screening to date of ICD-10 ear/hearing diagnosis, measured in days, up to 9 months from date of screening in Year 1 and Year 2
Secondary outcomes (3)
Change in prevalence of hearing loss
Based on audiometric assessment criteria, compared between intervention and active comparator
Measured: Annual audiometric assessment at Year 1 and Year 2
Change in hearing-related quality of life
Measured using Hearing Environments and Reflection on Quality of Life (HEAR-QL) questionnaire, compared between intervention and active comparator
Measured: Annual questionnaire assessment at Year 1 and Year 2
Change in school performance
Measure of math and reading performance using AIMSweb, compared between intervention and active comparator
Measured: 3 times annually in Year 1 and Year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2017
- Study start10 Oct 2017
- Primary completion21 Feb 2020
- Study completion21 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,481 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norton Sound Health Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, Johns Hopkins University, Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Samantha Kleindienst Robler, AuD, PhD, Principal investigator, Norton Sound Health CorporationSusan D Emmett, MD, MPH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03309553
- Sponsor's protocol ID
- AD-1602-34571
- Other IDs
- AD-1602-34751
- Status last verified
- Jun 2020
- First submitted
- 29 Sep 2017
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jin FQ, Huang O, Kleindienst Robler S, Morton S, Platt A, Egger JR, Emmett SD, Palmeri ML. A Hybrid Deep Learning Approach to Identify Preventable Childhood Hearing Loss. Ear Hear. 2023 Sep-Oct 01;44(5):1262-1270. doi: 10.1097/AUD.0000000000001380. Epub 2023 Jun 15.
PubMed 37318215Emmett SD, Platt A, Gallo JJ, Labrique AB, Wang NY, Inglis-Jenson M, Jenson CD, Hofstetter P, Hicks KL, Ross AA, Egger JR, Robler SK. Prevalence of Childhood Hearing Loss in Rural Alaska. Ear Hear. 2023 Sep-Oct 01;44(5):1240-1250. doi: 10.1097/AUD.0000000000001368. Epub 2023 Jun 8.
PubMed 37287104Robler SK, Platt A, Jenson CD, Meade Inglis S, Hofstetter P, Ross AA, Wang NY, Labrique A, Gallo JJ, Egger JR, Emmett SD. Changing the Paradigm for School Hearing Screening Globally: Evaluation of Screening Protocols From Two Randomized Trials in Rural Alaska. Ear Hear. 2023 Jul-Aug 01;44(4):877-893. doi: 10.1097/AUD.0000000000001336. Epub 2023 Mar 13.
PubMed 36907833Hicks KL, Robler SK, Simmons RA, Ross A, Egger JR, Emmett SD. Hearing-related quality of life in children and adolescents in rural Alaska. Laryngoscope Investig Otolaryngol. 2022 Dec 1;8(1):269-278. doi: 10.1002/lio2.973. eCollection 2023 Feb.
PubMed 36846414Hicks KL, Robler SK, Platt A, Morton SN, Egger JR, Emmett SD. Environmental Factors for Hearing Loss and Middle Ear Disease in Alaska Native Children and Adolescents: A Cross-Sectional Analysis from a Cluster Randomized Trial. Ear Hear. 2023 Jan-Feb 01;44(1):2-9. doi: 10.1097/AUD.0000000000001265. Epub 2022 Aug 23.
PubMed 35998103Marrone NL, Nieman CL, Coco L. Community-Based Participatory Research and Human-Centered Design Principles to Advance Hearing Health Equity. Ear Hear. 2022 Jul-Aug 01;43(Suppl 1):33S-44S. doi: 10.1097/AUD.0000000000001183. Epub 2020 Jun 13.
PubMed 35724253Emmett SD, Platt A, Turner EL, Gallo JJ, Labrique AB, Inglis SM, Jenson CD, Parnell HE, Wang NY, Hicks KL, Egger JR, Halpin PF, Yong M, Ballreich J, Robler SK. Mobile health school screening and telemedicine referral to improve access to specialty care in rural Alaska: a cluster- randomised controlled trial. Lancet Glob Health. 2022 Jul;10(7):e1023-e1033. doi: 10.1016/S2214-109X(22)00184-X.
PubMed 35714630Robler SK, Inglis SM, Gallo JJ, Parnell HE, Ivanoff P, Ryan S, Jenson CD, Ross A, Labrique A, Wang NY, Emmett SD. Hearing Norton Sound: community involvement in the design of a mixed methods community randomized trial in 15 Alaska Native communities. Res Involv Engagem. 2020 Nov 3;6(1):67. doi: 10.1186/s40900-020-00235-0.
PubMed 33292651Emmett SD, Robler SK, Wang NY, Labrique A, Gallo JJ, Hofstetter P. Hearing Norton Sound: a community randomised trial protocol to address childhood hearing loss in rural Alaska. BMJ Open. 2019 Jan 15;9(1):e023078. doi: 10.1136/bmjopen-2018-023078.
PubMed 30782695Emmett SD, Robler SK, Gallo JJ, Wang NY, Labrique A, Hofstetter P. Hearing Norton Sound: mixed methods protocol of a community randomised trial to address childhood hearing loss in rural Alaska. BMJ Open. 2019 Jan 22;9(1):e023081. doi: 10.1136/bmjopen-2018-023081.
PubMed 30674486
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hearing Norton Sound: A Community Randomized Trial to Address Childhood Hearing Loss in Rural Alaska
- ClinicalTrials.gov ID
- NCT03309553
- Acronym / sponsor ID
- AD-1602-34571
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,481 participants (actual)
- Lead sponsor
- Norton Sound Health CorporationUniversity, hospital or other
- Collaborators
- Duke University, Johns Hopkins University, Patient-Centered Outcomes Research Institute
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 21 Feb 2020 (actual)
- Study completion
- 21 Feb 2020 (actual)
- First posted
- 13 Oct 2017 (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.
Hearing loss is a common health problem in Alaska. Up to 75% of children growing up in Alaskan villages experience frequent ear infections, one of the major treatable causes of hearing loss. Children with even mild hearing loss face many challenges. These children often experience speech and language delays and have trouble in school. Teens with hearing loss are more likely to drop out of school, and are at risk for having difficulty finding jobs as adults. Promptly diagnosing and treating hearing loss is important for preventing these consequences. Alaska mandates school-based hearing screening, but many children with hearing loss are not identified by the current screening protocol, and most who are referred never make it into the healthcare system for diagnosis and treatment.
Alaska has already developed innovative strategies to address hearing loss. A network of village health clinics staffed by community health aides provide local care, and telemedicine has been adopted in over 250 village clinics statewide. Despite being widely available, telemedicine has not yet been used in school hearing screenings to speed up the referral process.
Norton Sound Health Corporation has partnered with Duke and Johns Hopkins Universities to explore whether a new school screening and referral process that incorporates mobile, or mHealth, screening and telemedicine referral will reduce childhood hearing loss disparities in the Norton Sound region. Children from kindergarten through 12th grade in 15 Norton Sound villages will receive the current school screening protocol and the new mHealth screen. Villages will then be randomized to continue the current primary care referral process or to adopt telemedicine referral for school screenings. The investigators hypothesize that the new mHealth screening protocol will identify more children with hearing loss, and telemedicine referral will reduce time to diagnosis. By better identifying hearing loss and speeding up diagnosis and treatment, the investigators expect the burden of childhood hearing loss to drop, hearing-related quality of life to improve, and school performance to improve in villages with telemedicine referral compared to current primary care referral villages. If the study shows these positive effects, mHealth screening and the telemedicine referral process could be implemented in school districts across the state of Alaska to reducing childhood hearing loss disparities statewide.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Current Primary Care Referral Process | Active comparator | Other: Current Primary Care Referral ProcessIn villages randomized to the current primary care process, families will be notified if their children screen positive in exactly the same method each school had been using previously. This process involves a letter home to the parents, either sent with the child or by mail, requesting that the parent/caregiver bring the child to village health clinic for an evaluation. The list of referred children is also given to the Norton Sound Audiology Department, who reaches out to families to schedule appointments during the next available audiology clinic. |
| Expedited Telemedicine Referral | Experimental | Other: Telemedicine Referral ProcessIn villages randomized to the expedited telemedicine intervention, parents of children who screen positive will receive a phone call from the school or the clinic on the day of screening notifying them of the day and time of their child's telemedicine consultation appointment. Appointments will be made same-day or next-day, with community health aides (CHAs) who have dedicated time blocked off to perform telemedicine consults. Participating children screening positive will be transported to clinic for their appointment with adult chaperones. Parents are encouraged but not required to attend, except for children grades 2 and younger, for whom parental participation will be required. Nonparticipating children in communities assigned to the expedited telemedicine intervention arm will receive standard referral following the current school primary care referral process. |
Who may qualify
- Ages
- 4 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Student of the Bering Strait School District (BSSD) in Alaska
- All school-aged children, from Kindergarten through 12th grade in the school district are eligible to participate
- Parental signed consent to undergo routine hearing screening in the school setting
- Verbal assent from children enrolled in the study
Key exclusion criteria (3 listed)
- Not a student of the Bering Strait School District
- Parental consent for routine hearing screening not obtained
- Verbal assent not obtained
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 |
|---|---|---|
| Current Primary Care Referral ProcessChildren who screen positive for hearing loss will receive the same method each school had been using previously. This process involves a letter home to the parents, either sent with the child or by mail, requesting that the parent/caregiver bring the child to village health clinic for an evaluation. | Other | Current Primary Care Referral Process |
| Telemedicine Referral ProcessIn villages randomized to the expedited telemedicine intervention, parents of children who screen positive will receive a phone call from the school or the clinic on the day of screening notifying them of the day and time of their child's telemedicine consultation appointment. Appointments will be made same-day or next-day, with community health aides (CHAs) who have dedicated time blocked off to perform telemedicine consults. Participating children screening positive will be transported to clinic for their appointment with adult chaperones. Parents are encouraged but not required to attend, except for children grades 2 and younger, for whom parental participation will be required. Nonparticipating children in communities assigned to the expedited telemedicine intervention arm will receive standard referral following the current school primary care referral process. | Other | Expedited Telemedicine Referral |
Primary outcome
Time to diagnosis
Time frame: From date of screening to date of ICD-10 ear/hearing diagnosis, measured in days, up to 9 months from date of screening in Year 1 and Year 2
Comparing time to International Classification of Disease, Tenth Edition (ICD-10) ear/hearing diagnosis from date of screening between intervention and active comparator
3 secondary outcomes
Change in prevalence of hearing loss
Time frame: Annual audiometric assessment at Year 1 and Year 2
Change in hearing-related quality of life
Time frame: Annual questionnaire assessment at Year 1 and Year 2
Change in school performance
Time frame: 3 times annually in Year 1 and Year 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Derived from this study: PubMed 37318215Jin FQ, Huang O, Kleindienst Robler S, Morton S, Platt A, Egger JR, Emmett SD, Palmeri ML. A Hybrid Deep Learning Approach to Identify Preventable Childhood Hearing Loss. Ear Hear. 2023 Sep-Oct 01;44(5):1262-1270. doi: 10.1097/AUD.0000000000001380. Epub 2023 Jun 15.
- Derived from this study: PubMed 37287104Emmett SD, Platt A, Gallo JJ, Labrique AB, Wang NY, Inglis-Jenson M, Jenson CD, Hofstetter P, Hicks KL, Ross AA, Egger JR, Robler SK. Prevalence of Childhood Hearing Loss in Rural Alaska. Ear Hear. 2023 Sep-Oct 01;44(5):1240-1250. doi: 10.1097/AUD.0000000000001368. Epub 2023 Jun 8.
- Derived from this study: PubMed 36907833Robler SK, Platt A, Jenson CD, Meade Inglis S, Hofstetter P, Ross AA, Wang NY, Labrique A, Gallo JJ, Egger JR, Emmett SD. Changing the Paradigm for School Hearing Screening Globally: Evaluation of Screening Protocols From Two Randomized Trials in Rural Alaska. Ear Hear. 2023 Jul-Aug 01;44(4):877-893. doi: 10.1097/AUD.0000000000001336. Epub 2023 Mar 13.
- Derived from this study: PubMed 36846414Hicks KL, Robler SK, Simmons RA, Ross A, Egger JR, Emmett SD. Hearing-related quality of life in children and adolescents in rural Alaska. Laryngoscope Investig Otolaryngol. 2022 Dec 1;8(1):269-278. doi: 10.1002/lio2.973. eCollection 2023 Feb.
- Derived from this study: PubMed 35998103Hicks KL, Robler SK, Platt A, Morton SN, Egger JR, Emmett SD. Environmental Factors for Hearing Loss and Middle Ear Disease in Alaska Native Children and Adolescents: A Cross-Sectional Analysis from a Cluster Randomized Trial. Ear Hear. 2023 Jan-Feb 01;44(1):2-9. doi: 10.1097/AUD.0000000000001265. Epub 2022 Aug 23.
- Derived from this study: PubMed 35724253Marrone NL, Nieman CL, Coco L. Community-Based Participatory Research and Human-Centered Design Principles to Advance Hearing Health Equity. Ear Hear. 2022 Jul-Aug 01;43(Suppl 1):33S-44S. doi: 10.1097/AUD.0000000000001183. Epub 2020 Jun 13.
- Derived from this study: PubMed 35714630Emmett SD, Platt A, Turner EL, Gallo JJ, Labrique AB, Inglis SM, Jenson CD, Parnell HE, Wang NY, Hicks KL, Egger JR, Halpin PF, Yong M, Ballreich J, Robler SK. Mobile health school screening and telemedicine referral to improve access to specialty care in rural Alaska: a cluster- randomised controlled trial. Lancet Glob Health. 2022 Jul;10(7):e1023-e1033. doi: 10.1016/S2214-109X(22)00184-X.
- Derived from this study: PubMed 33292651Robler SK, Inglis SM, Gallo JJ, Parnell HE, Ivanoff P, Ryan S, Jenson CD, Ross A, Labrique A, Wang NY, Emmett SD. Hearing Norton Sound: community involvement in the design of a mixed methods community randomized trial in 15 Alaska Native communities. Res Involv Engagem. 2020 Nov 3;6(1):67. doi: 10.1186/s40900-020-00235-0.
- Derived from this study: PubMed 30782695Emmett SD, Robler SK, Wang NY, Labrique A, Gallo JJ, Hofstetter P. Hearing Norton Sound: a community randomised trial protocol to address childhood hearing loss in rural Alaska. BMJ Open. 2019 Jan 15;9(1):e023078. doi: 10.1136/bmjopen-2018-023078.
- Derived from this study: PubMed 30674486Emmett SD, Robler SK, Gallo JJ, Wang NY, Labrique A, Hofstetter P. Hearing Norton Sound: mixed methods protocol of a community randomised trial to address childhood hearing loss in rural Alaska. BMJ Open. 2019 Jan 22;9(1):e023081. doi: 10.1136/bmjopen-2018-023081.
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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.
Samantha Kleindienst Robler, AuD, PhD principal investigator
Norton Sound Health Corporation
Susan D Emmett, MD, MPH principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Current Primary Care Referral Process and Telemedicine Referral Process in people with Hearing Loss, run by Norton Sound Health Corporation 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 4 inclusion and 3 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 16 Jun 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to diagnosis (time frame: From date of screening to date of ICD-10 ear/hearing diagnosis, measured in days, up to 9 months from date of screening in Year 1 and Year 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 NCT03309553, which also lists 10 linked publications.
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 16 Jun 2020.