HealthyNCT01003041
The Influence of Hearing Discrete Phonemes in Mother's Voice in the Infant's Natural Environment and With Natural Melody on Developing Phonetic Categories Between 4-10 Months Old
An observational study of Healthy, run by Maaynei Hayesha Medical Center.
Trial summary
The purpose of this study is to record voice samples of infant's mothers, process in samples to a phonetic musical piece, play the phonetic musical piece to 4-10 month old infants, and then test the infants in a conditioned head turning test in lab, and to analyze the results. Read more about this study
- Who is it for?
- Ages 4 to 10 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to 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 4 to 10 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: normal newborn infants
Who may be able to join
- normal newborn infants
- males and females
- age 4 months to 10 months old
Who cannot join
- chronic illness
- hearing loss
- history of otitis media
- serious otitis media
About this study
The purpose of this study is to record voice samples of infant's mothers, process in samples to a phonetic musical piece, play the phonetic musical piece to 4-10 month old infants, and then test the infants in a conditioned head turning test in lab, and to analyze the results.
- Conditions
- Healthy
- Keywords
- healthy normal infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| lifestyle counseling | in the future parents will be advised to expose their infants to phonetic sounds in order to develop their phonetic categories in the future |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response by head-turning test to familiar and unfamiliar phonetic categories
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2009 (estimated)
- Study startOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maaynei Hayesha Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01003041
- Sponsor's protocol ID
- 1010
- Status last verified
- Oct 2009
- First submitted
- 27 Oct 2009
- Last updated
- 28 Oct 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Hearing Discrete Phonemes in Mother's Voice in the Infant's Natural Environment and With Natural Melody on Developing Phonetic Categories Between 4-10 Months Old
- ClinicalTrials.gov ID
- NCT01003041
- Acronym / sponsor ID
- 1010
- Conditions
- Healthy
- Keywords
- healthy normal infants
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Maaynei Hayesha Medical CenterUniversity, hospital or other
- Study start
- Oct 2009
- First posted
- 28 Oct 2009 (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 of this study is to record voice samples of infant's mothers, process in samples to a phonetic musical piece, play the phonetic musical piece to 4-10 month old infants, and then test the infants in a conditioned head turning test in lab, and to analyze the results.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lifestyle counseling | – | –in the future parents will be advised to expose their infants to phonetic sounds in order to develop their phonetic categories in the future |
Who may qualify
- Ages
- 4 to 10 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- normal newborn infants
Key inclusion criteria (3 listed)
- normal newborn infants
- males and females
- age 4 months to 10 months old
Key exclusion criteria (4 listed)
- chronic illness
- hearing loss
- history of otitis media
- serious otitis media
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Response by head-turning test to familiar and unfamiliar phonetic categories
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Maaynei Hayesha Medical Center.
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 3 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: status not confirmed, as of the sponsor's last update on 28 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Response by head-turning test to familiar and unfamiliar phonetic categories (time frame: one year). 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 28 Oct 2009.