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Velopharyngeal Insufficiency After Maxillomandibular Advancement Osteotomy in Obstructive Sleep Apnea Patients

NCT ID: NCT07301021

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-01

Study Completion Date

2027-12-01

Brief Summary

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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

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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.

Conditions

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Velopharyngeal Insufficiency Swallowing Nasality Speech

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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OSA patients after an MMA

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Prof. dr. J. de Lange, MD DMD

Prof.dr. Jan de Lange, Head of Department Oral and Maxillofacial Surgery (Amsterdam UMC)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Amsterdam UMC

Amsterdam, North Holland, Netherlands

Site Status

Countries

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Netherlands

Central Contacts

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Misha Tan, PhD student

Role: CONTACT

Phone: +31613125803

Email: [email protected]

Facility Contacts

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Misha Tan, PhD student

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 25604261 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11404624 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21948641 (View on PubMed)

Other Identifiers

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NL83076.018.23

Identifier Type: -

Identifier Source: org_study_id