Congenital DeafnessNCT03866850

Degenerative Consequences of Congenital Deafness

An observational study of Congenital Deafness, run by East Carolina University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 15 years and older
Conditions the study is for: Congenital Deafness
What is being tested?: Phase duration
Type of treatment: Lifestyle or therapy programme
How many people: 34 participants
Where: 1 siteUnited States
Study dates: 1 Aug 2019to 4 Apr 2023
Phase: Observational
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 15 years and older
All sexes
Child, Adult, Older adult

Study population: Children and adults with cochlear implants (Advanced Bionics and Cochlear Nucleus devices)

Who may be able to join

Cochlear Nucleus cochlear implant users or Advanced Bionics cochlear implant users
Native speakers of English
Early onset of deafness (< 3 years of age); no requirement for age at implantation
Late onset of deafness (> 3 years of age); matched in duration of deafness to the early onset group
Has had device experience for at least one year
Can be child or adult at the time of enrollment

Who cannot join

None

Trial locations and contacts

1 site in 1 country.

United States1 site

Department of Communication Sciences and Disorders, ECU
Greenville, North Carolina, 27834

Other trials in United States

About this study

In this study, the investigators will study one of the basic biophysical properties of the auditory nerve, charge integration, behaviorally (detection threshold versus phase duration functions). The investigators will compare charge integration in two subject groups: congenitally deafened and deafened at a later age in life. The investigators will then examine if behaviorally estimated neural excitation patterns differ between short phase duration and long phase duration stimulation. Lastly, The investigators will measure if speech recognition improves with using long phase duration stimulation, relative to using the standard default short phase duration stimulation. The primary endpoint of the study is speech recognition, and the secondary endpoints are the steepness of the detection threshold versus phase duration functions, and the width of psychophysically estimated neural excitation.

Conditions: Congenital Deafness
Being tested: Phase duration

What participants receive

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

Phase durationBehavioural
We will vary the phase duration in the stimulation, and examine detection threshold, spatial spread of neural excitation, and speech recognition as the outcomes.

Study groups in NCT03866850
Study group	Role	What they receive
Cochlear implant users with late-onset deafness		Examine charge integration (Detection threshold as a function of phase duration). Examine neural spatial excitation patterns with long and short phase duration. Measure speech recognition using long and short phase duration stimulation patterns. Receives: Behavioral: Phase duration
Cochlear implant users with early-onset deafness		Examine charge integration (Detection threshold as a function of phase duration) and compare that with the late-onset group. Examine neural spatial excitation patterns with long and short phase duration within the non-leaky phase duration range. Measure speech recognition using long and short phase duration stimulation patterns. Receives: Behavioral: Phase duration

What is being measured

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

Slope of the strength duration function
Subjects will be measured for detection thresholds as a function of phase duration of the pulse train and the slope of the function will be derived.
Measured: starting 6 months post award notice and will take up to 4 years to complete

Secondary outcomes (2)

Psychophysically estimated neural excitation width
Subjects will be measured for psychophysical forward-masked spatial tuning curves using stimuli with long and short phase duration.
Measured: starting 6 months post award notice and will take up to 4 years to complete
Speech recognition using long phase duration
Subjects' speech recognition performance will be evaluated using CUNY and TIMIT sentences with long and short phase duration stimulation.
Measured: starting 6 months post award notice and will take up to 4 years to complete

Timeline

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

1 Aug 20194 Apr 2023

First posted7 Mar 2019
Study start1 Aug 2019
Primary completion4 Apr 2023
Study completion4 Apr 2023

Why it stopped: PI passed away. Ending grant and closing lab.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Congenital DeafnessStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03866850
Sponsor's protocol ID: Zhou_R01_study2
Status last verified: Apr 2023
First submitted: 5 Mar 2019
Last updated: 7 Apr 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Hancock KE, Chung Y, Delgutte B. Congenital and prolonged adult-onset deafness cause distinct degradations in neural ITD coding with bilateral cochlear implants. J Assoc Res Otolaryngol. 2013 Jun;14(3):393-411. doi: 10.1007/s10162-013-0380-5. Epub 2013 Mar 5.
PubMed 23462803
Hancock KE, Noel V, Ryugo DK, Delgutte B. Neural coding of interaural time differences with bilateral cochlear implants: effects of congenital deafness. J Neurosci. 2010 Oct 20;30(42):14068-79. doi: 10.1523/JNEUROSCI.3213-10.2010.
PubMed 20962228
Hardie NA, Shepherd RK. Sensorineural hearing loss during development: morphological and physiological response of the cochlea and auditory brainstem. Hear Res. 1999 Feb;128(1-2):147-65. doi: 10.1016/s0378-5955(98)00209-3.
PubMed 10082295
Leake PA, Snyder RL, Rebscher SJ, Moore CM, Vollmer M. Plasticity in central representations in the inferior colliculus induced by chronic single- vs. two-channel electrical stimulation by a cochlear implant after neonatal deafness. Hear Res. 2000 Sep;147(1-2):221-41. doi: 10.1016/s0378-5955(00)00133-7.
PubMed 10962187
McKay CM. Forward masking as a method of measuring place specificity of neural excitation in cochlear implants: a review of methods and interpretation. J Acoust Soc Am. 2012 Mar;131(3):2209-24. doi: 10.1121/1.3683248.
PubMed 22423717
Rattay F. Analysis of models for extracellular fiber stimulation. IEEE Trans Biomed Eng. 1989 Jul;36(7):676-82. doi: 10.1109/10.32099.
PubMed 2744791
Sharma A, Gilley PM, Dorman MF, Baldwin R. Deprivation-induced cortical reorganization in children with cochlear implants. Int J Audiol. 2007 Sep;46(9):494-9. doi: 10.1080/14992020701524836.
PubMed 17828665
Svirsky MA, Robbins AM, Kirk KI, Pisoni DB, Miyamoto RT. Language development in profoundly deaf children with cochlear implants. Psychol Sci. 2000 Mar;11(2):153-8. doi: 10.1111/1467-9280.00231.
PubMed 11273423
Teoh SW, Pisoni DB, Miyamoto RT. Cochlear implantation in adults with prelingual deafness. Part II. Underlying constraints that affect audiological outcomes. Laryngoscope. 2004 Oct;114(10):1714-9. doi: 10.1097/00005537-200410000-00007.
PubMed 15454759
Trune DR. Influence of neonatal cochlear removal on the development of mouse cochlear nucleus: I. Number, size, and density of its neurons. J Comp Neurol. 1982 Aug 20;209(4):409-24. doi: 10.1002/cne.902090410.
PubMed 7130465
van den Honert C, Stypulkowski PH. Physiological properties of the electrically stimulated auditory nerve. II. Single fiber recordings. Hear Res. 1984 Jun;14(3):225-43. doi: 10.1016/0378-5955(84)90052-2.
PubMed 6480511
Kong YY, Deeks JM, Axon PR, Carlyon RP. Limits of temporal pitch in cochlear implants. J Acoust Soc Am. 2009 Mar;125(3):1649-57. doi: 10.1121/1.3068457.
PubMed 19275322

Want to know more?

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

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

Questions to ask the study team

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

See locations

RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Pitch Perception and Memory: Deficits and Training
Cochlear Implants
RecruitingPhase 1/2
A Study to Investigate the Safety of OpCT-001 in Adults Who Have Primary Photoreceptor Disease (CLARICO)
Primary Photoreceptor Disease, Retinitis Pigmentosa (RP)
RecruitingPhase 3
KHENERFIN Study: A Trial to Evaluate the Efficacy and Safety of Sonlicromanol in Primary Mitochondrial Diseases
Mitochondrial Diseases, Maternally Inherited Diabetes and Deafness (MIDD)
RecruitingPhase 3
A 24-Month Trial of NPI-001 for the Preservation of Photoreceptors in Retinitis Pigmentosa Associated With Usher Syndrome
Retinitis Pigmentosa (RP), Usher Syndrome

All Congenital Deafness trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Degenerative Consequences of Congenital Deafness
ClinicalTrials.gov ID: NCT03866850
Acronym / sponsor ID: Zhou_R01_study2
Conditions: Congenital Deafness
Study type: Observational
Recruitment status: TerminatedReason stopped: PI passed away. Ending grant and closing lab.
Enrolment: 34 participants (actual)
Lead sponsor: East Carolina UniversityUniversity, hospital or other
Study start: 1 Aug 2019 (actual)
Primary completion: 4 Apr 2023 (actual)
Study completion: 4 Apr 2023 (actual)
First posted: 7 Mar 2019 (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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Cochlear implant users with late-onset deafness	–	Behavioral: Phase durationExamine charge integration (Detection threshold as a function of phase duration). Examine neural spatial excitation patterns with long and short phase duration. Measure speech recognition using long and short phase duration stimulation patterns.
Cochlear implant users with early-onset deafness	–	Behavioral: Phase durationExamine charge integration (Detection threshold as a function of phase duration) and compare that with the late-onset group. Examine neural spatial excitation patterns with long and short phase duration within the non-leaky phase duration range. Measure speech recognition using long and short phase duration stimulation patterns.

Who may qualify

Ages: 15 years and older
Sex: All
Age groups: Child, Adult, Older adult
Study population: Children and adults with cochlear implants (Advanced Bionics and Cochlear Nucleus devices)

Key inclusion criteria (6 listed)

Cochlear Nucleus cochlear implant users or Advanced Bionics cochlear implant users
Native speakers of English
Early onset of deafness (< 3 years of age); no requirement for age at implantation
Late onset of deafness (> 3 years of age); matched in duration of deafness to the early onset group
Has had device experience for at least one year

Key exclusion criteria (1 listed)

None

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
Phase durationWe will vary the phase duration in the stimulation, and examine detection threshold, spatial spread of neural excitation, and speech recognition as the outcomes.	Behavioural	Cochlear implant users with early-onset deafness, Cochlear implant users with late-onset deafness

Primary outcome

Slope of the strength duration function
Time frame: starting 6 months post award notice and will take up to 4 years to complete
Subjects will be measured for detection thresholds as a function of phase duration of the pulse train and the slope of the function will be derived.

2 secondary outcomes

Psychophysically estimated neural excitation width
Time frame: starting 6 months post award notice and will take up to 4 years to complete
Speech recognition using long phase duration
Time frame: starting 6 months post award notice and will take up to 4 years to complete

Results and safety

The study was stopped early (reason given: PI passed away. Ending grant and closing lab.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
Background: PubMed 23462803Hancock KE, Chung Y, Delgutte B. Congenital and prolonged adult-onset deafness cause distinct degradations in neural ITD coding with bilateral cochlear implants. J Assoc Res Otolaryngol. 2013 Jun;14(3):393-411. doi: 10.1007/s10162-013-0380-5. Epub 2013 Mar 5.
Background: PubMed 20962228Hancock KE, Noel V, Ryugo DK, Delgutte B. Neural coding of interaural time differences with bilateral cochlear implants: effects of congenital deafness. J Neurosci. 2010 Oct 20;30(42):14068-79. doi: 10.1523/JNEUROSCI.3213-10.2010.
Background: PubMed 10082295Hardie NA, Shepherd RK. Sensorineural hearing loss during development: morphological and physiological response of the cochlea and auditory brainstem. Hear Res. 1999 Feb;128(1-2):147-65. doi: 10.1016/s0378-5955(98)00209-3.
Background: PubMed 10962187Leake PA, Snyder RL, Rebscher SJ, Moore CM, Vollmer M. Plasticity in central representations in the inferior colliculus induced by chronic single- vs. two-channel electrical stimulation by a cochlear implant after neonatal deafness. Hear Res. 2000 Sep;147(1-2):221-41. doi: 10.1016/s0378-5955(00)00133-7.
Background: PubMed 22423717McKay CM. Forward masking as a method of measuring place specificity of neural excitation in cochlear implants: a review of methods and interpretation. J Acoust Soc Am. 2012 Mar;131(3):2209-24. doi: 10.1121/1.3683248.
Background: PubMed 2744791Rattay F. Analysis of models for extracellular fiber stimulation. IEEE Trans Biomed Eng. 1989 Jul;36(7):676-82. doi: 10.1109/10.32099.
Background: PubMed 17828665Sharma A, Gilley PM, Dorman MF, Baldwin R. Deprivation-induced cortical reorganization in children with cochlear implants. Int J Audiol. 2007 Sep;46(9):494-9. doi: 10.1080/14992020701524836.
Background: PubMed 11273423Svirsky MA, Robbins AM, Kirk KI, Pisoni DB, Miyamoto RT. Language development in profoundly deaf children with cochlear implants. Psychol Sci. 2000 Mar;11(2):153-8. doi: 10.1111/1467-9280.00231.
Background: PubMed 15454759Teoh SW, Pisoni DB, Miyamoto RT. Cochlear implantation in adults with prelingual deafness. Part II. Underlying constraints that affect audiological outcomes. Laryngoscope. 2004 Oct;114(10):1714-9. doi: 10.1097/00005537-200410000-00007.
Background: PubMed 7130465Trune DR. Influence of neonatal cochlear removal on the development of mouse cochlear nucleus: I. Number, size, and density of its neurons. J Comp Neurol. 1982 Aug 20;209(4):409-24. doi: 10.1002/cne.902090410.
Background: PubMed 6480511van den Honert C, Stypulkowski PH. Physiological properties of the electrically stimulated auditory nerve. II. Single fiber recordings. Hear Res. 1984 Jun;14(3):225-43. doi: 10.1016/0378-5955(84)90052-2.
Background: PubMed 19275322Kong YY, Deeks JM, Axon PR, Carlyon RP. Limits of temporal pitch in cochlear implants. J Acoust Soc Am. 2009 Mar;125(3):1649-57. doi: 10.1121/1.3068457.
Individual participant dataSharing planned: No

Related trials for Congenital Deafness

RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Pitch Perception and Memory: Deficits and Training
Cochlear Implants
RecruitingPhase 1/2
A Study to Investigate the Safety of OpCT-001 in Adults Who Have Primary Photoreceptor Disease (CLARICO)
Primary Photoreceptor Disease, Retinitis Pigmentosa (RP)
RecruitingPhase 3
KHENERFIN Study: A Trial to Evaluate the Efficacy and Safety of Sonlicromanol in Primary Mitochondrial Diseases
Mitochondrial Diseases, Maternally Inherited Diabetes and Deafness (MIDD)
RecruitingPhase 3
A 24-Month Trial of NPI-001 for the Preservation of Photoreceptors in Retinitis Pigmentosa Associated With Usher Syndrome
Retinitis Pigmentosa (RP), Usher Syndrome

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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

An observational study of Congenital Deafness, run by East Carolina University 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 6 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: stopped early, as of the sponsor's last update on 7 Apr 2023. 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 was stopped early (reason given: PI passed away. Ending grant and closing lab.). Results are not available in the source record.

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?

Slope of the strength duration function (time frame: starting 6 months post award notice and will take up to 4 years to complete). 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 NCT03866850, which also lists 12 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 7 Apr 2023.