An observational study in Velopharyngeal Insufficiency, Swallowing and Nasality, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Not yet recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-20.
Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Observational
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.
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.
OSA patients who undergo a maxillomandibular advancement
Exclusion Criteria:
Patients with obstructive sleep apnea (OSA) who underwent a maxillomandibular advancement (MMA)
Nasality
Nasality 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.
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
Swallowing
FOIS (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
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
The 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
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)
Functional 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.
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
Neuro 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.
Time frame: T0 preoperative T1 +6 weeks post op T2 +3 months post op T3 +6 months post op T4 +12 months post op
Descriptive data
AHI = apnea/hypoapnea index: Normal: AHI \< 5 events/hour Mild sleep apnea: AHI 5-14 events/hour Moderate sleep apnea: AHI 15-29 events/hour Severe sleep apnea: AHI ≥ 30 events/hour Higher AHI values indicate more severe sleep-disordered breathing. Age: in years Weight: in KG Hight: in cm BMI: Underweight: BMI \< 18.5 Normal weight: BMI 18.5-24.9 Overweight: BMI 25-29.9 Obesity: BMI ≥ 30 Gender: male/female
Time frame: Pre operative data extraction
Plan to share: Yes — The IPD will be shared with other researches: speech therapist and my supervisor.
Supporting information: Study protocol, Sap, Icf
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)