Velopharyngeal Insufficiency After Maxillomandibular Advancement Osteotomy in Obstructive Sleep Apnea Patients

NCT07301021 | Not Yet Recruiting DMC

• 1 other identifier: NL83076.018.23
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Velopharyngeal Insufficiency; Swallowing; Nasality; Speech

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Timpoints: T0 preoperative, T1 6 weeks after surgery, T2 3 months after surgery, T3 6 months after surgery, T4 1 year after surgery

Secondary Outcomes (4)

• Swallowing

  T0 preoperative, T1 6 weeks after surgery, T2 3 months after surgery, T3 6 months after surgery, T4 1 year after surgery

• Speech

  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)

  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

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

Other Outcomes (1)

• Descriptive data

  Pre operative data extraction

Study Arms (1)

OSA patients after an MMA

Patients with obstructive sleep apnea (OSA) who underwent a maxillomandibular advancement (MMA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

OSA patients who undergo a maxillomandibular advancement

You may qualify if:

• Age \> 18 years
• Mild to severe OSA
• Indication for MMA for OSA treatment

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam UMC

Amsterdam, North Holland, Netherlands

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Velopharyngeal Insufficiency; Speech; Sleep Apnea, Obstructive; Communication Disorders

Condition Hierarchy (Ancestors)

Mouth Abnormalities; Mouth Diseases; Stomatognathic Diseases; Pharyngeal Diseases; Stomatognathic System Abnormalities; Otorhinolaryngologic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Verbal Behavior; Communication; Behavior; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Misha Tan, PhD student

CONTACT

+31613125803; m.l.tan@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.dr. Jan de Lange, Head of Department Oral and Maxillofacial Surgery (Amsterdam UMC)

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: December 24, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 01-06-2025 - 01-06-2028
• 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.

Locations

NL (1)