Velopharyngeal Insufficiency in Children With Isolated or Combined Cleft PalateNCT05838261
Prospective Evaluation of Speech Function Through Patient- and Parent-response Outcome Measurements in Velopharyngeal Insufficiency
An observational study of Velopharyngeal Insufficiency in Children With Isolated or Combined Cleft Palate, run by Umeå University at 6 sites in Sweden.
Trial summary
Cleft lip and/or palate (CL/P) is the most common congenital malformation, with about one in 500 children born with CL/P in Sweden, corresponding to approximately 175 births annually. Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Velopharyngeal Insufficiency in Children With Isolated or Combined Cleft Palate
- What is being tested?
- Pharyngeal flap
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 6 sitesSweden
- Study dates
- 24 Aug 2022to 1 Jan 2026
- 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 0 to 17 years
- All sexes
- Child
Study population: All children < 18 years with isolated or combined cleft palate undergoing surgical treatment of velopharyngeal insufficiency in any of the 6 specialized cleft centers in Sweden will be invited to the study.
Who may be able to join
- All children < 18 years of age with isolated or combined cleft palate that will undergo pharyngeal flap surgery due to velopharyngeal insufficiency, as well as their parents, in any of the 6 specialized cleft center in Sweden.
Who cannot join
- Cognitive impairment making it difficult to understand the study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Sweden6 sites, 6 recruiting
- Not yet recruiting
Sahlgrenska University Hospital
Gothenburg
Patrik Boivie, MD PhD
- Not yet recruiting
Linköping University Hospital
Linköping
Louise Rydén, MD PhD
- Recruiting
Skånes University Hospital
Malmö
Malin Schaar Johansson
- Recruiting
Karolinska University Hospital
Stockholm
Björn Schönmeyr, MD PhD
- Recruiting
Plastic Surgery Unit, Umeå University hospital
Umeå
Rebecca Wiberg, MD, PhD, +4670-3884369, anna.rebecca.wiberg@gmail.com
- Not yet recruiting
Uppsala University Hospital
Uppsala
Malin Hakelius, MD PhD
Åsa Okhiria, PhD
About this study
Official title: Prospective Evaluation of Speech Function Through Patient- and Parent-response Outcome Measurements Following Surgical Treatment of Velopharyngeal Insufficiency in Children With Isolated or Combined Cleft Palate
Cleft lip and/or palate (CL/P) is the most common congenital malformation, with about one in 500 children born with CL/P in Sweden, corresponding to approximately 175 births annually. Depending on the extent of the cleft palate, the degree of functional loss varies, but both eating, hearing, speech, bite and appearance can be affected.
Patients treated for isolated or combined cleft palate may suffer from velopharyngeal insufficiency (VPI), which means difficulties in closing the passage between the oral and nasal cavities during speech. Velopharyngeal insufficiency is associated with hypernasality, audible nasal air leakage and weak articulation, which might lead to difficulties with communication and social stigmatization.
Read more
The most common form of speech-improving surgery is a posterior based velopharyngeal flap, creating a bridge between the palate and the posterior pharyngeal wall to more easily compensate for the abnormal airflow through the nose during speech. However, surgical management of VPI is challenging, with variable success rates reported in the literature. In a retrospectively based questionnaire study on patients who underwent surgical treatment of VPI, 30% experienced only a small speech improvement or no improvement at all. In addition, postoperative speech impairment have also been reported, as well as perioperative bleeding and postoperative sleep apnea. Thus, selecting the patients who benefit most from speech-improving surgery is therefore of great importance.
The aim with the current study is evaluation of speech function through patient- and parent-response outcome measurements following surgical treatment of velopharyngeal insufficiency in children with isolated or combined cleft palate.
- Being tested
- Pharyngeal flap
- Keywords
- Velopharyngeal insufficiency, Pharyngeal flap, Patient- and parent-reported outcome measurements, Cleft palate
- Medical subject headings
- Velopharyngeal Insufficiency, Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharyngeal flapProcedure or surgery
Children with combined or isolated cleft palate with velopharyngeal insufficiency undergoing surgical treatment with pharyngeal flap will be evaluated with patient- and parent reported outcome measures before and after the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Children with cleft palate with velopharyngeal insufficiency undergoing surgical treatment | Children with combined or isolated cleft palate with velopharyngeal insufficiency undergoing surgical treatment with pharyngeal flap Receives: Procedure: Pharyngeal flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech function
Speech function will be evaluated through the patient response outcome measurement CLEFT-Q pre- and postoperatively. Each CLEFT-Q scale is transformed into scores that range from 0-100, with higher scores reflecting a better outcome.
Measured: Change in speech function will be evaluated preoperatively and 1 year postoperatively
Speech function
Speech function will be evaluated through the parent-response outcome measurement Intelligibility in Context Scale pre- and postoperatively. The maximum and minimum value ranges from 0-35 respectively, with higher scores reflecting a better outcome.
Measured: Change in speech function will be evaluated preoperatively and 1 year postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start24 Aug 2022
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Velopharyngeal Insufficiency in Children With Isolated or Combined Cleft PalateStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital, Uppsala University Hospital, University Hospital, Linkoeping, Skane University Hospital, Sahlgrenska University Hospital
- Responsible party
- Principal investigator, Rebecka Wiberg, Umeå University
- Investigators
- Rebecca Wiberg, MD PhD, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838261
- Sponsor's protocol ID
- 2023-VPI-RWiberg
- Status last verified
- May 2024
- First submitted
- 29 Mar 2023
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a multicenter study so the other researchers will be part of analysing the data, however only on group level.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Speech Function Through Patient- and Parent-response Outcome Measurements Following Surgical Treatment of Velopharyngeal Insufficiency in Children With Isolated or Combined Cleft Palate
- ClinicalTrials.gov ID
- NCT05838261
- Acronym / sponsor ID
- 2023-VPI-RWiberg
- Keywords
- Velopharyngeal insufficiency, Pharyngeal flap, Patient- and parent-reported outcome measurements, Cleft palate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Karolinska University Hospital, Uppsala University Hospital, University Hospital, Linkoeping, Skane University Hospital, Sahlgrenska University Hospital
- Study start
- 24 Aug 2022 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 1 May 2023 (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.
Cleft lip and/or palate (CL/P) is the most common congenital malformation, with about one in 500 children born with CL/P in Sweden, corresponding to approximately 175 births annually. Depending on the extent of the cleft palate, the degree of functional loss varies, but both eating, hearing, speech, bite and appearance can be affected.
Patients treated for isolated or combined cleft palate may suffer from velopharyngeal insufficiency (VPI), which means difficulties in closing the passage between the oral and nasal cavities during speech. Velopharyngeal insufficiency is associated with hypernasality, audible nasal air leakage and weak articulation, which might lead to difficulties with communication and social stigmatization.
The most common form of speech-improving surgery is a posterior based velopharyngeal flap, creating a bridge between the palate and the posterior pharyngeal wall to more easily compensate for the abnormal airflow through the nose during speech. However, surgical management of VPI is challenging, with variable success rates reported in the literature. In a retrospectively based questionnaire study on patients who underwent surgical treatment of VPI, 30% experienced only a small speech improvement or no improvement at all. In addition, postoperative speech impairment have also been reported, as well as perioperative bleeding and postoperative sleep apnea. Thus, selecting the patients who benefit most from speech-improving surgery is therefore of great importance.
The aim with the current study is evaluation of speech function through patient- and parent-response outcome measurements following surgical treatment of velopharyngeal insufficiency in children with isolated or combined cleft palate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with cleft palate with velopharyngeal insufficiency undergoing surgical treatment | – | Procedure: Pharyngeal flapChildren with combined or isolated cleft palate with velopharyngeal insufficiency undergoing surgical treatment with pharyngeal flap |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- All children < 18 years with isolated or combined cleft palate undergoing surgical treatment of velopharyngeal insufficiency in any of the 6 specialized cleft centers in Sweden will be invited to the study.
Key inclusion criteria (1 listed)
- All children < 18 years of age with isolated or combined cleft palate that will undergo pharyngeal flap surgery due to velopharyngeal insufficiency, as well as their parents, in any of the 6 specialized cleft center in Sweden.
Key exclusion criteria (1 listed)
- Cognitive impairment making it difficult to understand the study.
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 |
|---|---|---|
| Pharyngeal flapChildren with combined or isolated cleft palate with velopharyngeal insufficiency undergoing surgical treatment with pharyngeal flap will be evaluated with patient- and parent reported outcome measures before and after the surgery. | Procedure or surgery | Children with cleft palate with velopharyngeal insufficiency undergoing surgical treatment |
Primary outcome
Speech function
Time frame: Change in speech function will be evaluated preoperatively and 1 year postoperatively
Speech function will be evaluated through the patient response outcome measurement CLEFT-Q pre- and postoperatively. Each CLEFT-Q scale is transformed into scores that range from 0-100, with higher scores reflecting a better outcome.
Speech function
Time frame: Change in speech function will be evaluated preoperatively and 1 year postoperatively.
Speech function will be evaluated through the parent-response outcome measurement Intelligibility in Context Scale pre- and postoperatively. The maximum and minimum value ranges from 0-35 respectively, with higher scores reflecting a better outcome.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No. This is a multicenter study so the other researchers will be part of analysing the data, however only on group level.
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.
Rebecca Wiberg, MD PhD principal investigator
Umeå University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Velopharyngeal Insufficiency in Children With Isolated or Combined Cleft Palate, run by Umeå University at 6 sites in Sweden.
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 1 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 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Sweden. 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 Rebecca Wiberg, MD PhD (+46907850000, rebecka.wiberg@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech function (time frame: Change in speech function will be evaluated preoperatively and 1 year postoperatively). 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?
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 8 May 2024.