Severe, Profound DeafnessEarly Phase 1NCT00642343
Balance in Children With Cochlear Implants
A Early Phase 1 study testing Evaluation of motor proficiency skills., Evaluation of motor proficiency and Evaluation of motor proficiency. in people with Severe, Profound Deafness, run by University of Oklahoma at 1 site in United States.
Trial summary
The purpose is to test the balance of children with unilateral,bilateral cochlear implants and patients having unilateral implants before,bilateral implants after surgery,using the Bruininks-Oseretsky Test 2nd ed. to find out if the cochlear implants have an effect. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Severe, Profound Deafness
- What is being tested?
- Evaluation of motor proficiency skills., Evaluation of motor proficiency and Evaluation of motor proficiency.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Jun 2010
- Phase
- Early Phase 1
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children with cochlear implant(s) activated for at least two weeks before participation.
- Children with severe to profound deafness that have not received intervention.
Who cannot join
- Children with mental retardation, associated physical handicaps, or chronic sedative use prohibiting completion of the balance tests.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
The purpose is to test the balance of children with unilateral,bilateral cochlear implants and patients having unilateral implants before,bilateral implants after surgery,using the Bruininks-Oseretsky Test 2nd ed. to find out if the cochlear implants have an effect.
Read the detailed description
Hearing impairment has a significant impact on individual quality of life and stresses community resources. In the last two decades cochlear implantation has developed into the new standard of care for severe to profound haring loss. Recent studies have shown bilateral implantation improves sound localization and understanding of speech in noise. For children, this is seen as a significant benefit. As we begin to offer bilateral cochlear implants to a growing number of children it would be in our patient's best interest to evaluate whether or not this may cause balance impairment. We will evaluate the balance scores of children with bilateral cochlear implants, and compare their results to unilaterally implanted children and a hearing impaired population, with the Bruininks-Oseretsky Test 2nd ed (BOT2). In addition we will take a small group of unilaterally implanted patients and test them before and after a contralateral cochlear implant as a prospective study group.
- Conditions
- Severe, Profound Deafness
- Being tested
- Evaluation of motor proficiency skills., Evaluation of motor proficiency, Evaluation of motor proficiency.
- Keywords
- Balance, Severe, Profound deafness, Children, unilateral/bilateral cochlear implants, unilateral cochlear implant, bilateral cochlear implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of motor proficiency skills.Behavioural
Also called deaf children, balance, unilateral cochlear implants,, bilateral cochlear implants
The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.
Evaluation of motor proficiencyBehavioural
Also called balance,unilateral/bilateral cochlear implants,, deaf children
The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.
Evaluation of motor proficiencyBehavioural
Also called balance, unilateral/bilateral cochlear implants,, deaf children
The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.
Evaluation of motor proficiency.Behavioural
Also called deaf children, unilateral/bilateral cochlear implants,, balance
The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Children with severe to profound deafness that have not received any intervention. Receives: Behavioral: Evaluation of motor proficiency. |
| 2 | Active comparator | Children with an unilateral cochlear implant. Receives: Behavioral: Evaluation of motor proficiency skills. |
| 3 | Active comparator | Children with bilateral cochlear implants. Receives: Behavioral: Evaluation of motor proficiency |
| 4 | Active comparator | Children who receive their second implant during the duration of the study. Receives: Behavioral: Evaluation of motor proficiency |
What is being measured
The primary outcome is the main question the study is designed to answer.
The specific aim will be to compare the balance of children with cochlear implants to profoundly deaf children using the BOT2.
Measured: no earlier than 2 weeks following activation of implants
Secondary outcomes (1)
To evaluate the differences in balance function between children with bilateral cochlear implants compared to children with unilateral cochlear using implants the BOT2.
Measured: no earlier than 2 weeks after implant activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe, Profound 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Otolaryngology-Head and Neck Surgery Foundation
- Investigators
- Wayne Berryhill, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00642343
- Sponsor's protocol ID
- BALANCE W/COCHLEAR_BERRYHILL
- Status last verified
- Jun 2010
- First submitted
- 19 Mar 2008
- Last updated
- 15 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balance in Children With Cochlear Implants
- ClinicalTrials.gov ID
- NCT00642343
- Acronym / sponsor ID
- BALANCE W/COCHLEAR_BERRYHILL
- Conditions
- Severe, Profound Deafness
- Keywords
- Balance, Severe, Profound deafness, Children, unilateral/bilateral cochlear implants, unilateral cochlear implant, bilateral cochlear implants
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- American Academy of Otolaryngology-Head and Neck Surgery Foundation
- Study start
- Mar 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 25 Mar 2008 (estimated)
- 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.
The purpose is to test the balance of children with unilateral,bilateral cochlear implants and patients having unilateral implants before,bilateral implants after surgery,using the Bruininks-Oseretsky Test 2nd ed. to find out if the cochlear implants have an effect.
Detailed description
Hearing impairment has a significant impact on individual quality of life and stresses community resources. In the last two decades cochlear implantation has developed into the new standard of care for severe to profound haring loss. Recent studies have shown bilateral implantation improves sound localization and understanding of speech in noise. For children, this is seen as a significant benefit. As we begin to offer bilateral cochlear implants to a growing number of children it would be in our patient's best interest to evaluate whether or not this may cause balance impairment. We will evaluate the balance scores of children with bilateral cochlear implants, and compare their results to unilaterally implanted children and a hearing impaired population, with the Bruininks-Oseretsky Test 2nd ed (BOT2). In addition we will take a small group of unilaterally implanted patients and test them before and after a contralateral cochlear implant as a prospective study group.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Behavioral: Evaluation of motor proficiency.Children with severe to profound deafness that have not received any intervention. |
| 2 | Active comparator | Behavioral: Evaluation of motor proficiency skills.Children with an unilateral cochlear implant. |
| 3 | Active comparator | Behavioral: Evaluation of motor proficiencyChildren with bilateral cochlear implants. |
| 4 | Active comparator | Behavioral: Evaluation of motor proficiencyChildren who receive their second implant during the duration of the study. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children with cochlear implant(s) activated for at least two weeks before participation.
- Children with severe to profound deafness that have not received intervention.
Key exclusion criteria (1 listed)
- Children with mental retardation, associated physical handicaps, or chronic sedative use prohibiting completion of the balance tests.
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 |
|---|---|---|
| Evaluation of motor proficiency skills.Also: deaf children, balance, unilateral cochlear implants,, bilateral cochlear implantsThe balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored. | Behavioural | 2 |
| Evaluation of motor proficiencyAlso: balance,unilateral/bilateral cochlear implants,, deaf childrenThe balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored. | Behavioural | 3 |
| Evaluation of motor proficiencyAlso: balance, unilateral/bilateral cochlear implants,, deaf childrenThe balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored. | Behavioural | 4 |
| Evaluation of motor proficiency.Also: deaf children, unilateral/bilateral cochlear implants,, balanceThe balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored. | Behavioural | 1 |
Primary outcome
The specific aim will be to compare the balance of children with cochlear implants to profoundly deaf children using the BOT2.
Time frame: no earlier than 2 weeks following activation of implants
1 secondary outcome
To evaluate the differences in balance function between children with bilateral cochlear implants compared to children with unilateral cochlear using implants the BOT2.
Time frame: no earlier than 2 weeks after implant activation
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 15 Jun 2010.
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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.
Wayne Berryhill, MD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Evaluation of motor proficiency skills., Evaluation of motor proficiency and Evaluation of motor proficiency. in people with Severe, Profound Deafness, run by University of Oklahoma 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 2 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: finished, as of the sponsor's last update on 15 Jun 2010. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The specific aim will be to compare the balance of children with cochlear implants to profoundly deaf children using the BOT2. (time frame: no earlier than 2 weeks following activation of implants). 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 15 Jun 2010.