Velopharyngeal Insufficiency After Maxillomandibular Advancement Osteotomy in Obstructive Sleep Apnea Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Velopharyngeal Insufficiency, Swallowing, Nasality, Speech. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The aim of this study is to gain insight into the development of velopharyngeal insufficiency (VPI) in patients who have undergone maxillomandibular advancement osteotomy (MMA) as a treatment for obstructive sleep apnea syndrome (OSAS). A speech therapist evaluates nasality, speech, and swallowing before and after the surgery.
Detailed description
This study will be conducted at Amsterdam UMC. Adult patients with mild to severe obstructive sleep apnea syndrome (OSAS) who are eligible for maxillomandibular advancement (MMA) surgery will be invited to participate in this prospective cohort study. Patients will be evaluated by two speech therapists at four different time points: before surgery (T0), 6 weeks after surgery (T1), 3 months after surgery (T2), 6 months after surgery (T3) and 1 year after surgery (T4).
Patients will undergo objective assessments focusing on three components: nasality, speech, and swallowing. The Nasometer, a non-invasive analysis tool, will be used to measure the presence of nasality in speech production. Speech will be scored using the Cleft Audit Protocol for Speech - Augmented (CAPS-A), an instrument where speech therapists evaluate various aspects of speech performance. Swallowing will be assessed using the Functional Oral Intake Scale (FOIS), a scoring system that evaluates patients' swallowing abilities. Additionally, the swallowing speed/volume test will measure how quickly and how much water a patient can swallow. Thereby, for the subjective evaluation patients will receive the following questionnaires by email: OHIP-14 (oral health related quality of life), FOSQ (functional outcomes of sleep questionnaire), and the NSD (neurosensory disturbance questionnaire.
Primary outcome measures
- Nasality [Time frame: Timpoints: T0 preoperative, T1 6 weeks after surgery, T2 3 months after surgery, T3 6 months after surgery, T4 1 year after surgery]
Secondary outcome measures (4)
- Swallowing [Time frame: T0 preoperative, T1 6 weeks after surgery, T2 3 months after surgery, T3 6 months after surgery, T4 1 year after surgery]
- Speech [Time frame: T0 preoperative, T1 6 weeks after surgery, T2 3 months after surgery, T3 6 months after surgery, T4 1 year after surgery]
- Subjective outcomes: The Functional Outcomes of Sleep Questionnaire (FOSQ) [Time frame: T0 preoperative, T1 6 weeks after surgery, T2 3 months after surgery, T3 6 months after surgery, T4 1 year after surgery]
- Subjective outcome: Neuro Sensory Disturbance Questionnaire [Time frame: T0 preoperative T1 +6 weeks post op T2 +3 months post op T3 +6 months post op T4 +12 months post op]
Eligibility criteria
Inclusion criteria
- Age > 18 years
- Mild to severe OSA
- Indication for MMA for OSA treatment
Exclusion criteria
- patients who underwent other adjunctive procedures at the time of MMA (e.g., multipiece le Fort osteotomy, TMJ reconstruction
- Previous history of orthognathic surgery
- Previous history of orthognathic surgery
- Previous history of oropharyngeal surgery (UPPP or multi-level surgery)
- Cleft palate and syndromic patients
- Neuromusculair diseases which causes VPI, dysphagia or dysarthria
- Incapacity
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- Amsterdam UMC — Amsterdam
Publications
- Kummer AW, Marshall JL, Wilson MM. Non-cleft causes of velopharyngeal dysfunction: implications for treatment. Int J Pediatr Otorhinolaryngol. 2015 Mar;79(3):286-95. doi: 10.1016/j.ijporl.2014.12.036. Epub 2015 Jan 5. PMID 25604261
- Li KK, Troell RJ, Riley RW, Powell NB, Koester U, Guilleminault C. Uvulopalatopharyngoplasty, maxillomandibular advancement, and the velopharynx. Laryngoscope. 2001 Jun;111(6):1075-8. doi: 10.1097/00005537-200106000-00027. PMID 11404624
- Kummer AW. Types and causes of velopharyngeal dysfunction. Semin Speech Lang. 2011 May;32(2):150-8. doi: 10.1055/s-0031-1277717. Epub 2011 Sep 26. PMID 21948641
Identifiers
NCT: NCT07301021 · NL83076.018.23