HypernasalityNCT05273853
Speech Outcome After Partial Adenoidectomy in Patients With Risk of Hypernasality
A study testing Partial Adenoidectomy in people with Hypernasality, run by Sohag University at 1 site in Egypt.
Trial summary
Adenoid hypertrophy is a common cause of airway obstruction in children; it may lead to mouth breathing, nasal discharge, snoring, sleep apnea, and hyponasal speech. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Hypernasality
- What is being tested?
- Partial Adenoidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Feb 2022to 1 Dec 2022
- 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 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient with symptoms of adenoid hypertrophy.
- High risk to VPI:
- Short palate.
- Scarred palate after previous tonsillectomy.
- Occult submucous cleft.
- Deep pharynx.
- Repaired cleft palate.
Who cannot join
- Any neurological deficit, muscular disorder or structural defects of the palate (as cleft palate).
Trial locations and contacts
1 site in 1 country.
About this study
Adenoid hypertrophy is a common cause of airway obstruction in children; it may lead to mouth breathing, nasal discharge, snoring, sleep apnea, and hyponasal speech.
Read the detailed description
Adenoid hypertrophy is a common cause of airway obstruction in children; it may lead to mouth breathing, nasal discharge, snoring, sleep apnea, and hyponasal speech. It also contributes to the pathogenesis of rhinosinusitis and recurrent otitis media. However, the adenoid lies in the posterior nasopharyngeal wall and may act as a pad against the palate facilitating velopharyngeal closure, especially in patients with palatal abnormalities; Its presence can compensate for a short or poorly mobile palate. Following adenoidectomy, compensation is eliminated and velopharyngeal insufficiency (VPI) may result. Therefore, patients with palatal abnormalities (such as poor palatal mobility, short palate, occult submucosal cleft palate, scarred palate after previous tonsillectomy, and repaired cleft palate) are at high risk to develop hypernasality after complete adenoidectomy, and in such situations conservative or partial adenoidectomy is performed
- Conditions
- Hypernasality
- Being tested
- Partial Adenoidectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial AdenoidectomyProcedure or surgery
Partial removal of adenoid
| Study group | Role | What they receive |
|---|---|---|
| Patients with high risk of hypernasality | Other | In 1958, Gibb indicated an incidence of hypernasality (escape of air from nose as in patients with cleft palate) postadenoidectomy in approximately 1of 2000 cases. Closure pattern of velopharyngeal valve in children is veloadenoidal rather than velopharyngeal closure. Adenoid tissue is vital to velopharyngeal closure in children and its removal necessitates a change in the closure pattern of velopharyngeal valving. These changes are easily overcome if there is no anatomic abnormality Receives: Procedure: Partial Adenoidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech Outcome
Change of a degree of Nasal Tone during speech
Measured: 1 month after operation
Speech Outcome
Change of a degree of Nasal Tone during speech
Measured: 3 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start4 Feb 2022
- Primary completion4 Aug 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypernasalityStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Awida Hasb Allah, Sohag University
- Investigators
- Mohammed AE Ahmed, Professor, Study chair, Sohag Faculty Of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05273853
- Sponsor's protocol ID
- DAHAllah
- Status last verified
- Mar 2022
- First submitted
- 18 Feb 2022
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rowe MR, D'Antonio LL. Velopharyngeal dysfunction: evolving developments in evaluation. Curr Opin Otolaryngol Head Neck Surg. 2005 Dec;13(6):366-70. doi: 10.1097/01.moo.0000186204.53214.62.
PubMed 16282766
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Speech Outcome After Partial Adenoidectomy in Patients With Risk of Hypernasality
- ClinicalTrials.gov ID
- NCT05273853
- Acronym / sponsor ID
- DAHAllah
- Conditions
- Hypernasality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 4 Feb 2022 (actual)
- Primary completion
- 4 Aug 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 10 Mar 2022 (actual)
- 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.
Adenoid hypertrophy is a common cause of airway obstruction in children; it may lead to mouth breathing, nasal discharge, snoring, sleep apnea, and hyponasal speech.
Detailed description
Adenoid hypertrophy is a common cause of airway obstruction in children; it may lead to mouth breathing, nasal discharge, snoring, sleep apnea, and hyponasal speech. It also contributes to the pathogenesis of rhinosinusitis and recurrent otitis media. However, the adenoid lies in the posterior nasopharyngeal wall and may act as a pad against the palate facilitating velopharyngeal closure, especially in patients with palatal abnormalities; Its presence can compensate for a short or poorly mobile palate. Following adenoidectomy, compensation is eliminated and velopharyngeal insufficiency (VPI) may result. Therefore, patients with palatal abnormalities (such as poor palatal mobility, short palate, occult submucosal cleft palate, scarred palate after previous tonsillectomy, and repaired cleft palate) are at high risk to develop hypernasality after complete adenoidectomy, and in such situations conservative or partial adenoidectomy is performed
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with high risk of hypernasality | Other | Procedure: Partial AdenoidectomyIn 1958, Gibb indicated an incidence of hypernasality (escape of air from nose as in patients with cleft palate) postadenoidectomy in approximately 1of 2000 cases. Closure pattern of velopharyngeal valve in children is veloadenoidal rather than velopharyngeal closure. Adenoid tissue is vital to velopharyngeal closure in children and its removal necessitates a change in the closure pattern of velopharyngeal valving. These changes are easily overcome if there is no anatomic abnormality |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Patient with symptoms of adenoid hypertrophy.
- High risk to VPI:
Key exclusion criteria (1 listed)
- Any neurological deficit, muscular disorder or structural defects of the palate (as cleft palate).
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 |
|---|---|---|
| Partial AdenoidectomyPartial removal of adenoid | Procedure or surgery | Patients with high risk of hypernasality |
Primary outcome
Speech Outcome
Time frame: 1 month after operation
Change of a degree of Nasal Tone during speech
Speech Outcome
Time frame: 3 months after operation
Change of a degree of Nasal Tone during speech
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Results publication: PubMed 16282766Rowe MR, D'Antonio LL. Velopharyngeal dysfunction: evolving developments in evaluation. Curr Opin Otolaryngol Head Neck Surg. 2005 Dec;13(6):366-70. doi: 10.1097/01.moo.0000186204.53214.62.
- Individual participant dataSharing planned: No
Related trials for Hypernasality
Recruiting
Expiratory Muscle Strength Training for Hypernasal Speech in Children
Velopharyngeal Insufficiency, Velopharyngeal Incompetence Due to Cleft Palate
Not yet recruiting
Early Intervention in Infants With Unrepaired Cleft Palate: Language, Palatal Function, and Articulation.
Cleft Lip and Cleft Palate, Cleft Lip Palate
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.
Mohammed AE Ahmed, Professor study chair
Sohag Faculty Of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Partial Adenoidectomy in people with Hypernasality, run by Sohag University at 1 site in Egypt.
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 7 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: status not confirmed, as of the sponsor's last update on 10 Mar 2022. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dina A Hasb Allah, Resident (+201286000163, dina_ewaida_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech Outcome (time frame: 1 month after operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05273853, which also lists 1 linked publication.
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 10 Mar 2022.