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Hearing DisorderNCT00341874

Genetic Analyses of Nonsyndromic and Syndromic Deafness in Pakistan

An observational study of Hearing Disorder, run by National Institute on Deafness and Other Communication Disorders (NIDCD) at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Objective: One objective of this study is to genetically map and identify mutated genes for human hereditary hearing loss. A second objective is to study the function of these genes in the auditory system using mouse models. Read more about this study

Who is it for?
Ages 2 years and older
Conditions the study is for
Hearing Disorder
How many people
18,009 participants
Where
1 sitePakistan
Study dates
16 Mar 2000to not given
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 2 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: This study will ascertain subjects from consanguineous Pakistani families segregating hearing loss consisting of both nonsyndromic and syndromic forms of deafness of genetic etiology. Since a majority of Pakistani marriages are between first cousins, this tends to bring together the same recessive mutations for hearing loss with multiple affected individuals within single family lines, which is an advantage for this genetic study. A few years ago we stopped ascertaining families in India. We continue to ascertain both affected and unaffected Pakistani family members from age 2 years and up. Adults provide informed consent both for themselves and their children who agree to participate in this study. We will ascertain both genders and all Pakistani races and ethnicities.

Who may be able to join

  • Affected and unaffected members of families segregating deafness caused by genetic etiology.
  • Adults must be able to provide informed consent.
  • Adults must be able to provide informed consent for children who are at least two years of age
  • All communities, ethnicities, and races as found in Pakistan.

Who cannot join

  • Persons with non-genetic forms of hearing loss likely due to acquired causes such as an infection, head or noise trauma, or exposure to an ototoxic drug will not be included in this protocol
  • Syndromic forms of inherited deafness are excluded if the gene for the disorder is known and there is no reason to believe the disorder is genetically heterogeneous.
  • Subjects cannot provide informed consent or have a parent/guardian that cannot provide consent.
  • Children under the age of two years will not be included in this study because an objective audiological examination such as an ABR analysis may require sedation, which is presently not feasible in Pakistan.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • University of Punjab

    Lahore

Other trials in Pakistan

About this study

Objective: One objective of this study is to genetically map and identify mutated genes for human hereditary hearing loss. A second objective is to study the function of these genes in the auditory system using mouse models. Human hereditary hearing impairment is the result of abnormal ear development, abnormal ear function or both. Although the genes for numerous deafness loci have been mapped and identified, there are still many families segregating deafness as a monogenic trait but a mutant allele can t be ascribed to one of the currently reported deafness genes . In order to map and identify novel mutated genes associated with hearing loss in humans, we will continue to ascertain large families segregating syndromic and nonsyndromic deafness as a monogenic trait.

Study population: This study will ascertain subjects from consanguineous Pakistani families segregating hearing loss consisting of both nonsyndromic and syndromic forms of deafness of genetic etiology. Since a majority of Pakistani marriages are between first cousins, this tends to bring together the same recessive mutations for hearing loss with multiple affected individuals within single family lines, which is an advantage for this genetic study. A few years ago we stopped ascertaining families in India. We continue to ascertain both affected and unaffected Pakistani family members from age 2 years and up. Adults provide informed consent both for themselves and their children who agree to participate in this study. We will ascertain both genders and all Pakistani races and ethnicities.

Read more

Design: Subjects will be screened and consented by our collaborating Associate Investigator in Pakistan. After consenting, the subjects will undergo a history and physical, audiological assessment and testing, vestibular assessment and testing, and blood and urine analysis tests, along with a blood sample or buccal swab sample that will be used for genomic DNA extraction. Probands at the time of ascertainment are initially assumed to have a form of nonsyndromic deafness. Additional tests may be performed depending on the history or physical of the individual or after the deafness gene is identified. Data from functional studies in animal models may also point to other concomitant clinical features along with hearing loss. These additional tests may include: photographs or videotapes of a subject s body and face; eye and vision examinations for those with suspected or known eyesight problems related to their genetic hearing loss mutations, and EKGs and/or Echocardiograms for those with suspected or known heart problems related to their genetic hearing loss mutations. Urine and blood analyses may be requested for those individuals with genetic nephritic issues or infertility. For example, when a deaf female individual in a family is subsequently discovered to have Perrault syndrome, a recessive disorder characterized by hearing loss (usually the initial manifestation) and ovarian dysgenesis/primary amenorrhea, additional evaluations would then be conducted for a definitive diagnosis of Perrault syndrome. Such an evaluation would include a pelvic ultrasound scan and measurements of serum estrogen and gonadotropins. Similarly, in some of these families, hearing impaired males may be asked about their fertility since the possibility of male infertility in families segregating Perrault syndrome remains an open question. For genetic analyses, genomic DNA extracted from a blood sample or a buccal swab from affected and unaffected members of families segregating hereditary hearing loss will be genetically screened with polymorphic markers (STRs or SNPs) for linkage to the known deafness loci. The hearing phenotype of children (>2 years old), adolescent and adult subjects will be assigned on the basis of performance from audiological examinations. Genomic DNA from families where deafness is found to be unlinked to the known deafness loci will then be used in genome wide screens with approximately 950,000 SNP markers distributed across the entire human genome to identify novel deafness loci. Alternatively, DNA samples from affected and unaffected individuals will undergo whole exome sequencing (WES) or whole genome sequencing (WGS) with a focus on potentially pathogenic variants located only in chromosomal regions of markers genetically linked to deafness. Subsequently, novel deafness genes will be positionally identified and their functions studied.

Outcome measures: Novel deafness loci and genes associated with hearing loss will be identified and will provide new insight into mechanisms required for sound transduction in humans. Data from this study is likely to be the basis of commercially available tests for early diagnosis and timely genetic counseling for at risk couples as well as the development of strategies to preserve hearing and prevent hearing loss.

Read the detailed description

Objective: One objective of this study is to genetically map and identify mutated genes for human hereditary hearing loss. A second objective is to study the function of these genes in the auditory system using mouse models. Human hereditary hearing impairment is the result of abnormal ear development, abnormal ear function or both. Although the genes for numerous deafness loci have been mapped and identified, there are still many families segregating deafness as a monogenic trait but a mutant allele can t be ascribed to one of the currently reported deafness genes . In order to map and identify novel mutated genes associated with hearing loss in humans, we will continue to ascertain large families segregating syndromic and nonsyndromic deafness as a monogenic trait.

Study population: This study will ascertain subjects from consanguineous Pakistani families segregating hearing loss consisting of both nonsyndromic and syndromic forms of deafness of genetic etiology. Since a majority of Pakistani marriages are between first cousins, this tends to bring together the same recessive mutations for hearing loss with multiple affected individuals within single family lines, which is an advantage for this genetic study. A few years ago we stopped ascertaining families in India. We continue to ascertain both affected and unaffected Pakistani family members from age 2 years and up. Adults provide informed consent both for themselves and their children who agree to participate in this study. We will ascertain both genders and all Pakistani races and ethnicities.

Design: Subjects will be screened and consented by our collaborating Associate Investigator in Pakistan. After consenting, the subjects will undergo a history and physical, audiological assessment and testing, vestibular assessment and testing, and blood and urine analysis tests, along with a blood sample or buccal swab sample that will be used for genomic DNA extraction. Probands at the time of ascertainment are initially assumed to have a form of nonsyndromic deafness. Additional tests may be performed depending on the history or physical of the individual or after the deafness gene is identified. Data from functional studies in animal models may also point to other concomitant clinical features along with hearing loss. These additional tests may include: photographs or videotapes of a subject s body and face; eye and vision examinations for those with suspected or known eyesight problems related to their genetic hearing loss mutations, and EKGs and/or Echocardiograms for those with suspected or known heart problems related to their genetic hearing loss mutations. Urine and blood analyses may be requested for those individuals with genetic nephritic issues or infertility. For example, when a deaf female individual in a family is subsequently discovered to have Perrault syndrome, a recessive disorder characterized by hearing loss (usually the initial manifestation) and ovarian dysgenesis/primary amenorrhea, additional evaluations would then be conducted for a definitive diagnosis of Perrault syndrome. Such an evaluation would include a pelvic ultrasound scan and measurements of serum estrogen and gonadotropins. Similarly, in some of these families, hearing impaired males may be asked about their fertility since the possibility of male infertility in families segregating Perrault syndrome remains an open question. For genetic analyses, genomic DNA extracted from a blood sample or a buccal swab from affected and unaffected members of families segregating hereditary hearing loss will be genetically screened with polymorphic markers (STRs or SNPs) for linkage to the known deafness loci. The hearing phenotype of children (>2 years old), adolescent and adult subjects will be assigned on the basis of performance from audiological examinations. Genomic DNA from families where deafness is found to be unlinked to the known deafness loci will then be used in genome wide screens with approximately 950,000 SNP markers distributed across the entire human genome to identify novel deafness loci. Alternatively, DNA samples from affected and unaffected individuals will undergo whole exome sequencing (WES) or whole genome sequencing (WGS) with a focus on potentially pathogenic variants located only in chromosomal regions of markers genetically linked to deafness. Subsequently, novel deafness genes will be positionally identified and their functions studied.

Outcome measures: Novel deafness loci and genes associated with hearing loss will be identified and will provide new insight into mechanisms required for sound transduction in humans. Data from this study is likely to be the basis of commercially available tests for early diagnosis and timely genetic counseling for at risk couples as well as the development of strategies to preserve hearing and prevent hearing loss.

Keywords
DNA Mutations, Genetic Variations, GENETIC LINKAGE, Usher Syndrome, BLINDNESS, Natural History
Medical subject headings
Hearing Disorders, Usher Syndromes, Blindness

What participants receive

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

Study groups in NCT00341874
Study groupRoleWhat they receive
1Subjects with hearing loss consisting of both nonsyndromic and syndromic forms of deafness of genetic etiology

What is being measured

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

  1. To genetically map and identify additional genes causing hereditary hearing impairment in humans.

    -The number of novel deafness loci that we genetically map-The number of novel deafness genes we identify

    Measured: Ongoing

Secondary outcomes (1)
  1. To study the function of genes in the auditory system

    -The structures and functions of the deafness genes revealed -Novel insight gained studying unrecognized hearing processes and pathophysiologies due to mutations of deafness genes we discover -Genotype/phenotype correlations that we identify that can be used to facilitate genetic diagnosis of hereditary hearing loss

    Measured: Ongoing

Timeline

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

  1. First posted21 Jun 2006 (estimated)
  2. Study start16 Mar 2000

Resources

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
18,009 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00341874
Sponsor's protocol ID
999993016
Other IDs
OH93-DC-016
Status last verified
9 Sep 2026
First submitted
19 Jun 2006
Last updated
26 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hearing Disorder, run by National Institute on Deafness and Other Communication Disorders (NIDCD) at 1 site in Pakistan.

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 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 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. 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?

To genetically map and identify additional genes causing hereditary hearing impairment in humans. (time frame: Ongoing). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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