Baltimore HEARS: Hearing Health Equity Through Accessible Research & Solutions (HEARS)

September 6, 2022 updated by: Johns Hopkins University

Baltimore HEARS Study: Addressing Hearing Impairment and Social Engagement Through Community-delivered Hearing Care

Age-related hearing loss is highly prevalent and hearing health care is underutilized. The primary objective of the proposed randomized controlled trial is to investigate the efficacy of a community health worker (CHW)-delivered hearing loss intervention program. A preceding pilot study demonstrated preliminary effectiveness of the intervention program in reducing self-reported hearing handicap, and highlighted its acceptability among the target demographic. The proposed trial will now expand upon lessons learned through previous pilot studies and expand to other affordable residences for low-to-moderate income older adults in Baltimore. Primary outcome measurements will investigate intervention effects on hearing handicap, with secondary measurements investigating effects on domains such as social isolation and quality of life. This trial is a first-in-kind investigation of a novel community-based intervention that addresses hearing loss in a vulnerable, urban population.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
151

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Catholic Charities
      • Baltimore, Maryland, United States, 21215
        • Weinberg Senior Living Communities

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 60 years or older
  • English-speaking
  • Aural-oral verbal communication as primary communication modality
  • Post-lingual hearing loss (Audiometric pure tone averages [0.5-4kHz] in both ears >25 dB)
  • Does not currently use a hearing amplification device or hearing aid
  • Signed informed consent to participate in all study related activities
  • Willing to regularly use listening device once provided for the remainder of their time in the study
  • Hearing handicap as measured by HHIE-S score >8
  • Able to follow study instructions

Exclusion Criteria:

  • Individuals who do not fulfill inclusion criteria
  • Evidence of ear disease or pathology requiring further medical evaluation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Immediate Treatment Group
Immediate treatment with Baltimore HEARS intervention
Behavioral: Baltimore HEARS
Tailored aural rehabilitation for participant and communication partner (if applicable)
Device: Baltimore HEARS
Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
PLACEBO_COMPARATOR: Delayed Treatment Group
3-month delayed treatment with Baltimore HEARS intervention
Behavioral: Baltimore HEARS
Tailored aural rehabilitation for participant and communication partner (if applicable)
Device: Baltimore HEARS
Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE-S)
Time Frame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)

Measure was collected through a one-on-one interview with a trained data collector. Higher scores indicate increased hearing handicap.

Scoring:

0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap

Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a worsening in hearing handicap.
Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Revised UCLA Loneliness Scale
Time Frame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)

Measure was collected via a one-on-one interview conducted by a trained data collector.

Score is the sum of 20-item self-reported measure. Scores range from 20 to 80.

Score ranges:

20-34 - Low degree of loneliness 35-49 - Moderate degree of loneliness 50-64 - Moderately high degree of loneliness 65-80 - High degree of loneliness.

Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a worsening in degree of loneliness.
Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Change From Baseline in Self-reported Depression in Patient Health Questionnaire (PHQ-9)
Time Frame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)

Measure collected via one-on-one interview conducted by trained data collectors.

Total of 9 questions, scored from 0 to 3. The score from each question are summed to a total score, which can range from 0 to 27.

Interpretation of Total Score Total Score Depression Severity 0 No depression 1-4 Minimal depression 5-9 Mild depression 10-14 Moderate depression 15-19 Moderately severe depression 20-27 Severe depression.

Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a worsening in depression severity.
Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Change From Baseline in Short Form-12 (SF-12) Mental Component Score
Time Frame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)

The 12-Item Short Form Survey (SF-12) was collected through a one-on-one interview with a trained data collector.

The 12-Item Short Form Survey (SF-12) measures the construct of self-reported health-related quality of life. Here we report the mental component which relates to mental health functioning. Score ranges from 0-100 with higher scores indicating better mental health functioning.

Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a better health state.
Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Change From Baseline in Short Form -12 (SF-12) Physical Component Score
Time Frame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)

The 12-Item Short Form Survey (SF-12) was collected through a one-on-one interview with a trained data collector.

The 12-Item Short Form Survey (SF-12) measures the construct of self-reported health-related quality of life. Here we report the physical component which relates to physical health functioning. Score ranges from 0-100 with higher scores indicating better physical health functioning.

Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a better health state.
Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Change From Baseline in Cohen Social Network Index (SNI): Network Diversity
Time Frame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Change from baseline in total number of high contact roles the participant interacts with at least every 2 weeks (such as family, friends, work). Maximum of 12 roles included on the measure. An increase in the score from baseline (a positive number) indicates a more diverse network.
Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Change From Baseline in Cohen Social Network Index (SNI): Social Network Size
Time Frame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Change from baseline in total number of individuals in high contact roles the participant interacts with at least every 2 weeks (such as family, friends, work). .An increase in the number of individuals from baseline (a positive number) indicates an increase in their social network size.
Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Change From Baseline in Valuation of Life
Time Frame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)

This self-reported 13 question measure asks the participant how much they agree or disagree on a 5 point Likert scale when asked a statement about the meaning of life and personal goals. Score ranges from 0 to 65. Higher score means higher value of life.

Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher value of life.
Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Computer Self-Efficacy
Time Frame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)

A 5 question measure surveying self-reported self-efficacy of computer use on a 5 point Likert scale. Score ranges from 0 to 25.

Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Device Self-Efficacy
Time Frame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)

A 5 question measure surveying self-reported device self-efficacy on a 5 point Likert scale. Score ranges from 0 to 25.

Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Listening Device Interest
Time Frame: Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)

A 5 question measure surveying self-reported self-efficacy of listening device interest on a 5 point Likert scale. Score ranges from 0 to 25.

Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Baseline and 3 months post-intervention (Immediate Group) or 3 months post-baseline (Delayed Group)
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Total Score
Time Frame: Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)

This 5 question survey measures listening self efficacy on a 0-10 scale in different situations such as being able to understand a conversation in a quiet room to a crowded restaurant. Participants answer with a higher number the more confident they are in the presented situation. Maximum possible score is 50.

Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Complex Listening
Time Frame: Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)

This measure is the combined score of two questions where a participant self-reported their listening self efficacy on a 0-10 scale in complex listening situations. Participants answer with a higher number the more confident they are in the presented situation. Score ranges from 0 to 20.

Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Directed Listening
Time Frame: Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)

This measure is the combined score of two questions where a participant self-reported their listening self efficacy on a 0-10 scale in complex listening situations. Participants answer with a higher number the more confident they are in the presented situation. Score ranges from 0 to 20.

Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Dialog in Quiet
Time Frame: Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)

This measure is a participant's self-reported listening self efficacy on a 0-10 score scale in a dialog in quiet listening situation. Participants answer with a higher number the more confident they are in the presented situation. Maximum possible score is 10.

Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)
Change From Baseline in Hearing Knowledge
Time Frame: Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)

This 5 question measure asks participants about their hearing knowledge based on the information presented in the intervention. The score ranges from 0 to 5.

Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates more hearing knowledge.
Baseline and 3 month post-intervention (immediate group) or 3 month post-baseline (delayed group)
Change From Baseline in Hearing Handicap Inventory for the Elderly (HHIE-S)
Time Frame: Baseline and 12 months post-intervention

Measure was collected through a one-on-one interview with a trained data collector. Higher scores indicate increased hearing handicap.

Scoring:

0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap.

Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a worsening in hearing handicap.
Baseline and 12 months post-intervention
Change From Baseline in Revised UCLA Loneliness Scale
Time Frame: Baseline and 12 months post-intervention

Measure was collected via a one-on-one interview conducted by a trained data collector.

Score is the sum of 20-item self-reported measure. Scores range from 20 to 80.

Score ranges:

20-34 - Low degree of loneliness 35-49 - Moderate degree of loneliness 50-64 - Moderately high degree of loneliness 65-80 - High degree of loneliness.

Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a worsening in degree of loneliness.
Baseline and 12 months post-intervention
Change From Baseline in Self-reported Depression in Patient Health Questionnaire (PHQ-9)
Time Frame: Baseline and 12 months post-intervention

Measure collected via one-on-one interview conducted by trained data collectors.

Total of 9 questions, scored from 0 to 3. The score from each question are summed to a total score, which can range from 0 to 27.

Interpretation of Total Score Total Score Depression Severity 0 No depression 1-4 Minimal depression 5-9 Mild depression 10-14 Moderate depression 15-19 Moderately severe depression 20-27 Severe depression.

Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a worsening in depression severity.
Baseline and 12 months post-intervention
Change From Baseline in Short Form -12 (SF-12) Mental Component Score
Time Frame: Baseline and 12 months post-intervention

The 12-Item Short Form Survey (SF-12) was collected through a one-on-one interview with a trained data collector.

The 12-Item Short Form Survey (SF-12) measures the construct of self-reported health-related quality of life. Here we report the mental component which relates to mental health functioning. Score ranges from 0-100 with higher scores indicating better mental health functioning.

Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a better health state.
Baseline and 12 months post-intervention
Change From Baseline in Short Form -12 (SF-12) Physical Component Score
Time Frame: Baseline and 12 months post-intervention

The 12-Item Short Form Survey (SF-12) was collected through a one-on-one interview with a trained data collector.

The 12-Item Short Form Survey (SF-12) measures the construct of self-reported health-related quality of life. Here we report the physical component which relates to physical health functioning. Score ranges from 0-100 with higher scores indicating better physical health functioning.

Change from baseline is reported. An increase in the score from baseline (a positive number) indicates a better health state.
Baseline and 12 months post-intervention
Change From Baseline in Cohen (Social Network Index) SNI: Network Diversity
Time Frame: Baseline and 12 months post-intervention
Change from baseline in total number of high contact roles the participant interacts with at least every 2 weeks (such as family, friends, work). Maximum of 12 roles included on the measure. An increase in the number of roles from baseline (a positive number) indicates a more diverse network.
Baseline and 12 months post-intervention
Change From Baseline in Cohen Social Network Index (SNI): Social Network Size
Time Frame: Baseline and 12 months post-intervention
Change from baseline in total number of individuals in high contact roles the participant interacts with at least every 2 weeks (such as family, friends, work). .An increase in the number of individuals from baseline (a positive number) indicates an increase in their social network size.
Baseline and 12 months post-intervention
Change From Baseline in Valuation of Life
Time Frame: Baseline and 12 months post-intervention

This self-reported 13 question measure asks the participant how much they agree or disagree on a 5 point Likert scale when asked a statement about the meaning of life and personal goals. Score ranges from 0 to 65. Higher score means higher value of life.

Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher value of life.
Baseline and 12 months post-intervention
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Device Self-Efficacy
Time Frame: Baseline and 12 months post-intervention

A 5 question measure surveying self-reported device self-efficacy on a 5 point Likert scale. Score ranges from 0 to 25.

Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Baseline and 12 months post-intervention
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Computer Self-Efficacy
Time Frame: Baseline and 12 months post-intervention

A 5 question measure surveying self-reported self-efficacy of computer use on a 5 point Likert scale. Score ranges from 0 to 25.

Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Baseline and 12 months post-intervention
Change From Baseline in Adapted From Attitudes Towards Computers Questionnaire (ATCQ): Listening Device Interest
Time Frame: Baseline and 12 months post-intervention

A 5 question measure surveying self-reported self-efficacy of listening device interest on a 5 point Likert scale. Score ranges from 0 to 25.

Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Baseline and 12 months post-intervention
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Total Score
Time Frame: Baseline and 12 months post-intervention

This 5 question survey measures listening self efficacy on a 0-10 scale in different situations such as being able to understand a conversation in a quiet room to a crowded restaurant. Participants answer with a higher number the more confident they are in the presented situation. Maximum possible score is 50.

Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Baseline and 12 months post-intervention
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Complex Listening
Time Frame: Baseline and 12 months post-intervention

This measure is the combined score of two questions where a participant self-reported their listening self efficacy on a 0-10 scale in complex listening situations. Participants answer with a higher number the more confident they are in the presented situation. Score ranges from 0 to 20.

Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Baseline and 12 months post-intervention
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Directed Listening
Time Frame: Baseline and 12 months post-intervention

This measure is the combined score of two questions where a participant self-reported their listening self efficacy on a 0-10 scale in directed listening situations. Participants answer with a higher number the more confident they are in the presented situation. Score ranges from 0 to 20.

Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Baseline and 12 months post-intervention
Change From Baseline in Adapted From Listening Self-Efficacy Questionnaire (LSEQ): Dialog in Quiet
Time Frame: Baseline and 12 months post-intervention

This measure is a participant's self-reported listening self efficacy on a 0-10 scale in a directed listening situation. Participants answer with a higher number the more confident they are in the presented situation. Maximum possible score is 10.

Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates a higher self-efficacy.
Baseline and 12 months post-intervention
Change From Baseline in Hearing Knowledge
Time Frame: Baseline and 12 months post-intervention

This 5 question measure asks participants about their hearing knowledge based on the information presented in the intervention. Score ranges from 0 to 5.

Change from baseline score is reported. An increase in the score from baseline (a positive number) indicates more hearing knowledge.
Baseline and 12 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Carrie L Nieman, MD, MPH, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 18, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 17, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 14, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 22, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00144968
  • R33DC015062-03 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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