Velopharyngeal Insufficiency After Maxillomandibular Advancement Osteotomy in Obstructive Sleep Apnea Patients (VPIMMA)

March 18, 2026 updated by: Prof. dr. J. de Lange, MD DMD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

OSA patients who undergo a maxillomandibular advancement

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
OSA patients after an MMA
Patients with obstructive sleep apnea (OSA) who underwent a maxillomandibular advancement (MMA)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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

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
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

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
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

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.
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

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.
T0 preoperative T1 +6 weeks post op T2 +3 months post op T3 +6 months post op T4 +12 months post op

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Descriptive data
Time Frame: Pre operative data extraction

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
Pre operative data extraction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 30, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 24, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL83076.018.23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The IPD will be shared with other researches: speech therapist and my supervisor.

IPD Sharing Time Frame

01-06-2025 - 01-06-2028

IPD Sharing Access Criteria

The speech therapist will have access to all data as she is responsible for conducting the measurements. I will also have access to all data since I am responsible for analyzing it and monitoring the study. My supervisor will have access to the outcomes, which are anonymized.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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