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Velopharyngeal Insufficiency After Maxillomandibular Advancement Osteotomy in Obstructive Sleep Apnea Patients

Velopharyngeal Insufficiency After Maxillomandibular Advancement Osteotomy in Obstructive Sleep Apnea Patients

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07301021
Acronym
VPIMMA
Enrollment
28
Registered
2025-12-24
Start date
2026-05-01
Completion date
2027-12-01
Last updated
2026-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasality, Speech, Swallowing, Velopharyngeal Insufficiency

Keywords

maxillomandibular advancement, obstructive sleep apnea, velopharyngeal insufficiency, speech therapy, swallowing, nasality, speech

Brief summary

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.

Interventions

None listed

Sponsors

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
NasalityTimpoints: T0 preoperative, T1 6 weeks after surgery, T2 3 months after surgery, T3 6 months after surgery, T4 1 year after surgeryNasality is measured using the Nasometer. The outcome consists of three scores: oral, nasal, and mixed. The nasality score is expressed as a percentage (0-100%), where a higher score indicates greater nasality. These scores will be compared across five time points.

Secondary

MeasureTime frameDescription
SwallowingT0 preoperative, T1 6 weeks after surgery, T2 3 months after surgery, T3 6 months after surgery, T4 1 year after surgeryFOIS (functional oral intake scale), swallow volume and swallow time will be evaluated by the speech therapist. The FOIS is used to describe the level of oral food and liquid intake in individuals with swallowing difficulties. The scale ranges from 0 to 7, where: 0: Nothing by mouth (NPO) - the individual does not take any food or liquid orally. 1. Tube dependent with minimal attempts of food or liquid - primarily tube-fed but may have some minimal oral intake. 2. Tube dependent with consistent oral intake of food or liquid - mostly tube-fed but regularly takes some oral intake. 3. Tube dependent with oral intake of food or liquid without special preparation - mostly tube-fed but oral intake is not modified. 4. Total oral diet of a single consistency - the individual eats only one consistency of food or liquid. 5. Total oral diet with multiple consistencies but requiring special preparation or compensations - eats various consistencies but with mod
SpeechT0 preoperative, T1 6 weeks after surgery, T2 3 months after surgery, T3 6 months after surgery, T4 1 year after surgeryThe Cleft Audit Protocol for Speech - Adult (CAPS-A) is a standardized assessment tool designed to evaluate speech outcomes in individuals with cleft lip and/or palate. It focuses on identifying speech characteristics commonly affected by cleft conditions, such as resonance, nasal emission, articulation, and overall speech intelligibility. What CAPS-A measures: Resonance: The degree of nasal quality in the voice (e.g., hypernasality or hyponasality). Nasal Emission: The presence of air escaping through the nose during speech, which can affect clarity. Articulation: Accuracy and clarity of speech sounds, especially those that may be distorted due to structural or functional issues. Overall Intelligibility: How well the speech can be understood by listeners. Outcome measures: CAPS-A uses a 5-point scale to rate the severity of certain speech characteristics, such as resonance and nasal emission, ranging from no impairment to severe impairment. Additionally, the presence or absen
Subjective outcomes: The Functional Outcomes of Sleep Questionnaire (FOSQ)T0 preoperative, T1 6 weeks after surgery, T2 3 months after surgery, T3 6 months after surgery, T4 1 year after surgeryFunctional Outcomes of Sleep Questionnaire (FOSQ) The Functional Outcomes of Sleep Questionnaire (FOSQ) is a patient-reported outcome measure designed to assess the impact of excessive daytime sleepiness on daily activities and quality of life. It evaluates how sleep disorders affect a person's ability to carry out routine tasks and engage in social and occupational activities. What it measures: The FOSQ covers multiple domains including general productivity, activity level, vigilance, social outcomes, and intimacy/sexual relationships. It reflects the functional limitations caused by sleepiness rather than just sleep symptoms alone. Outcome measures: The FOSQ produces a total score and subscale scores for each domain. Scores typically range from 0 to 4 or 5 per item, with higher scores indicating better functional status and less impact of sleepiness. The total score summarizes overall functional status related to sleepiness, with lower scores reflecting greater impairment.
Subjective outcome: Neuro Sensory Disturbance QuestionnaireT0 preoperative T1 +6 weeks post op T2 +3 months post op T3 +6 months post op T4 +12 months post opNeuro Sensory Disturbance Questionnaire The Neuro Sensory Disturbance Questionnaire is used to assess sensory symptoms related to neurological conditions, such as numbness, tingling, burning, or altered sensation. It helps to quantify the presence and severity of sensory disturbances that may affect daily functioning. What it measures: The questionnaire evaluates the type, frequency, and intensity of sensory symptoms. It may also include questions on the impact of these symptoms on daily activities and quality of life. Outcome measures: Scores are often based on ordinal scales (e.g., 3- or 5-point scales) rating severity or frequency of symptoms. The questionnaire may provide subscale scores for different sensory modalities (e.g., pain, numbness). A total score can be calculated to reflect overall neuro-sensory disturbance, with higher scores indicating more severe or frequent symptoms.

Countries

Netherlands

Contacts

CONTACTMisha Tan, PhD student
m.l.tan@amsterdamumc.nl+31613125803

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026