Sleep ApneaNCT01695967
Turbinate Cauterization in Pediatric Patients With Nasal Obstruction
A study testing turbinate cauterization in people with Sleep Apnea and Nasal Obstruction, run by Eastern Virginia Medical School at 1 site in United States.
Trial summary
patients will be placed in 2 groups, with or without turbinate cautery ( a surgical method to reduce the size of the skin covered bones in the nose), at the time of adenoidectomy and tonsillectomy. Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Sleep Apnea, Nasal Obstruction
- What is being tested?
- turbinate cauterization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Dec 2020
- 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 3 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ages 3-16
- obstructive sleep apnea warranting adenotonsillectomy
- history of daytime nasal obstruction and or mouth breathing
- failed medical treatment with either oral anti-histamine or nasal steroid spray.
- turbinate hypertrophy on Physical Exam defined by >50% obstruction
Who cannot join
- <3 or >16
- unwillingness to comply with study procedures
- congenital head and neck malformations, genetic syndromes, craniofacial anomalies
- no evidence of turbinate hypertrophy or symptoms of nasal obstruction
- pregnancy or breastfeeding
- bleeding disorders
- current therapy with coumadin or Pradaxa
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of the King's Daughters
Norfolk, Virginia, 23507
About this study
Official title: Turbinate Cauterization in Pediatric Patients With Nasal Obstruction A Randomized Prospective Trial
patients will be placed in 2 groups, with or without turbinate cautery ( a surgical method to reduce the size of the skin covered bones in the nose), at the time of adenoidectomy and tonsillectomy. It will compare the amount of nasal congestion for each group with the idea that it will be less if treated with turbinate cauterization. Assessments from baseline to 6 months post procedure will be compared between the two groups.
Read the detailed description
To assess if inferior turbinate cautery improves nasal obstruction in children undergoing adenotonsillectomy.
- Conditions
- Sleep Apnea, Nasal Obstruction
- Being tested
- turbinate cauterization
- Keywords
- nasal obstruction
- Medical subject headings
- Sleep Apnea Syndromes, Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
turbinate cauterizationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Turbinate Cauterization | Experimental | Turbinate Cauterization will be completed. Receives: Procedure: turbinate cauterization |
| control | No intervention | no turbinate cauterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
# of participants with improved nasal obstruction score from baseline to 6 months
Baseline assessment compared to 6 mo post surgery. The SN-5 Nasal Obstruction and Sinonasal Quality of Life instrument tools will be used to record nasal obstruction symptom scores.
Measured: baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Virginia Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina Baldassari M.D., Eastern Virginia Medical School
- Investigators
- Christina Baldassari, MD, Principal investigator, Eastern Virginia Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01695967
- Sponsor's protocol ID
- version 3 03Mar2012
- Status last verified
- Aug 2021
- First submitted
- 24 Sep 2012
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turbinate Cauterization in Pediatric Patients With Nasal Obstruction A Randomized Prospective Trial
- ClinicalTrials.gov ID
- NCT01695967
- Acronym / sponsor ID
- version 3 03Mar2012
- Conditions
- Sleep Apnea, Nasal Obstruction
- Keywords
- nasal obstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Eastern Virginia Medical SchoolUniversity, hospital or other
- Study start
- Aug 2012 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 28 Sep 2012 (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.
patients will be placed in 2 groups, with or without turbinate cautery ( a surgical method to reduce the size of the skin covered bones in the nose), at the time of adenoidectomy and tonsillectomy. It will compare the amount of nasal congestion for each group with the idea that it will be less if treated with turbinate cauterization. Assessments from baseline to 6 months post procedure will be compared between the two groups.
Detailed description
To assess if inferior turbinate cautery improves nasal obstruction in children undergoing adenotonsillectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Turbinate Cauterization | Experimental | Procedure: turbinate cauterizationTurbinate Cauterization will be completed. |
| control | No intervention | –no turbinate cauterization |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- ages 3-16
- obstructive sleep apnea warranting adenotonsillectomy
- history of daytime nasal obstruction and or mouth breathing
- failed medical treatment with either oral anti-histamine or nasal steroid spray.
- turbinate hypertrophy on Physical Exam defined by >50% obstruction
Key exclusion criteria (7 listed)
- <3 or >16
- unwillingness to comply with study procedures
- congenital head and neck malformations, genetic syndromes, craniofacial anomalies
- no evidence of turbinate hypertrophy or symptoms of nasal obstruction
- pregnancy or breastfeeding
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 |
|---|---|---|
| turbinate cauterization | Procedure or surgery | Turbinate Cauterization |
Primary outcome
# of participants with improved nasal obstruction score from baseline to 6 months
Time frame: baseline and 6 months
Baseline assessment compared to 6 mo post surgery. The SN-5 Nasal Obstruction and Sinonasal Quality of Life instrument tools will be used to record nasal obstruction symptom scores.
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 19 Aug 2021.
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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.
Christina Baldassari, MD principal investigator
Eastern Virginia Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing turbinate cauterization in people with Sleep Apnea and Nasal Obstruction, run by Eastern Virginia Medical School 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 5 inclusion and 7 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 19 Aug 2021. 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 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?
# of participants with improved nasal obstruction score from baseline to 6 months (time frame: baseline and 6 months). 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 19 Aug 2021.