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

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

Status: Not yet enrolling

Conditions: Nasality; Swallowing; Speech; Velopharyngeal Insufficiency

Study type: Observational

Funder types: Other

Identifiers

NCT07301021

NL83076.018.23

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

28 participants in 1 patient group

OSA patients after an MMA

Description:

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