Bilateral Complete Cleft Lip and/or AlveolusNCT01820689
Tympanometric Analysis in Cleft Palate
A study testing Tympanometry measurement in people with Bilateral Complete Cleft Lip and/or Alveolus, run by Centro de Diagnostico Auditivo de Cuiaba.
Trial summary
Purpose: Characterize the profile of tympanometric patients with cleft lip and palate in the post surgery period and correlate it with the time of palatoplasty. Methods: The sample consisted of 16 patients with cleft lip or palate totaling 32 ears treated at a Public University Hospital in Cuiabá (MT)- Brazil, in the… Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Bilateral Complete Cleft Lip and/or Alveolus
- What is being tested?
- Tympanometry measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Nov 2012
- Phase
- Interventional
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- cleft incisive trans unilateral or bilateral
- post-foramen complete or incomplete
Who cannot join
- isolated cleft lip
- associated syndromes
- malformation of ear
About this study
Official title: Tympanometric Analysis in Post Surgical Individuals With Cleft Palate
Purpose: Characterize the profile of tympanometric patients with cleft lip and palate in the post surgery period and correlate it with the time of palatoplasty. Methods: The sample consisted of 16 patients with cleft lip or palate totaling 32 ears treated at a Public University Hospital in Cuiabá (MT)- Brazil, in the post surgery moment that varied from three months to 33 years. Were sampled patients of both sexes, pediatrics and adults.
- Being tested
- Tympanometry measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tympanometry measurementOther
The tympanometry measurement will be verify and compared with the time of palatoplasty.
| Study group | Role | What they receive |
|---|---|---|
| Tympanometry measurement | Experimental | Not described Receives: Other: Tympanometry measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tympanic membrane mobility
Tympanic membrane mobility will be measured through the tympanometry and will be demonstrated through their complacency in ml.
Measured: 3 months to 33 years
Secondary outcomes (1)
Time of palatoplasty
Measured: 3 months to 33 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2013 (estimated)
- Study startJan 2012
- Primary completionSep 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bilateral Complete Cleft Lip and/or AlveolusStudies 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
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro de Diagnostico Auditivo de Cuiaba
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Mato Grosso
- Responsible party
- Principal investigator, Priscila de Araujo Lucas Rodrigues, Centro de Diagnostico Auditivo de Cuiaba
- Investigators
- P A Rodrigues, Doctor, Principal investigator, HUJM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820689
- Sponsor's protocol ID
- HUJM
- Status last verified
- Mar 2013
- First submitted
- 18 Mar 2013
- Last updated
- 29 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tympanometric Analysis in Post Surgical Individuals With Cleft Palate
- ClinicalTrials.gov ID
- NCT01820689
- Acronym / sponsor ID
- HUJM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Centro de Diagnostico Auditivo de CuiabaUniversity, hospital or other
- Collaborators
- Federal University of Mato Grosso
- Study start
- Jan 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 29 Mar 2013 (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.
Purpose: Characterize the profile of tympanometric patients with cleft lip and palate in the post surgery period and correlate it with the time of palatoplasty. Methods: The sample consisted of 16 patients with cleft lip or palate totaling 32 ears treated at a Public University Hospital in Cuiabá (MT)- Brazil, in the post surgery moment that varied from three months to 33 years. Were sampled patients of both sexes, pediatrics and adults.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tympanometry measurement | Experimental | Other: Tympanometry measurement |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- cleft incisive trans unilateral or bilateral
- post-foramen complete or incomplete
Key exclusion criteria (3 listed)
- isolated cleft lip
- associated syndromes
- malformation of ear
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 |
|---|---|---|
| Tympanometry measurementThe tympanometry measurement will be verify and compared with the time of palatoplasty. | Other | Tympanometry measurement |
Primary outcome
Tympanic membrane mobility
Time frame: 3 months to 33 years
Tympanic membrane mobility will be measured through the tympanometry and will be demonstrated through their complacency in ml.
1 secondary outcome
Time of palatoplasty
Time frame: 3 months to 33 years
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 29 Mar 2013.
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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.
P A Rodrigues, Doctor principal investigator
HUJM
Questions about this trial
What is this clinical trial studying?
A study testing Tympanometry measurement in people with Bilateral Complete Cleft Lip and/or Alveolus, run by Centro de Diagnostico Auditivo de Cuiaba.
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 3 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 29 Mar 2013. 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?
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?
Tympanic membrane mobility (time frame: 3 months to 33 years). 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 29 Mar 2013.