Long-term Impact of Maxillomandibular Advancement Osteotomy on Sleep Apnea Patients (MIMOSA)

Evaluation of the Long-term Impact of Maxillomandibular Advancement Osteotomy on Patients With Obstructive Sleep Apnea Syndrome

Background Maxillomandibular advancement surgery (MMA) has demonstrated high success rates, improving both the apnea-hypopnea index and associated patient' quality of life (QOL), in patients diagnosed with obstructive sleep apnea syndrome (OSAS). However, clinical relapse has been described in the target population, especially when associated with significant weight gain. Literature reporting the long-term impact of MMA for OSAS is lacking. The surgeons of the Division of Maxillofacial Surgery already started to perform this type of surgery in 1995.

Objectives The investigators aim to evaluate the long-term (minimum 15 years post-surgery) biologic and QOL impact of MMA in patients with OSAS. The biologic impact refers to the stability of hard and soft tissues and polysomnographic results.

Study design Retrospective study Both pre- en postoperative clinical imaging, polysomnography and quality of life questionnaires will be retrieved from all patients that were surgically treated with an MMA by one surgeon (CDC) between 01/11/1995 and 01/12/1999.

Conclusion Short-term data have shown high success rates for MMA in OSAS patients. However, long-term data are lacking. This retrospective study might provide us with more information about the incidence of clinical relapse fifteen to twenty years after surgery.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea

• Study Type: Observational
• Enrollment (Actual): 12

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients (n=10/12) with a clinically confirmed diagnosis of OSAS, that were treated with an MMA between 01/11/1995 and 01/12/1999 by one surgeon (CDC)

Description

Inclusion Criteria:

• clinically confirmed diagnosis of OSAS
• treated with an MMA between 01/11/1995 and 01/12/1999 by one surgeon (CDC)

Exclusion Criteria:

• not following abovementioned criteria

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
apnea-hypopnea index, as determined through polysomnography	minimum 15 years postoperative
oxygen saturation values, as determined through polysomnography	minimum 15 years postoperative

Secondary Outcome Measures

Outcome Measure	Time Frame
evolution of patient quality of life, through Epworth Sleepiness Scale	preoperative
Stability of hard and soft head and neck tissue, according to manual anthropometry	min 15 years postoperative
Evolution of apnea-hypopnea index, as determined through polysomnography	preoperative
Evolution of apnea-hypopnea index, as determined through polysomnography	immediately postoperative
oxygen saturation values, as determined through polysomnography	preoperative
oxygen saturation values, as determined through polysomnography	immediately postoperative
evolution of patient quality of life, through Epworth Sleepiness Scale	immediately postoperative
evolution of patient quality of life, through Epworth Sleepiness Scale	minimum 15 years postoperative
evolution of patient quality of life, through OSAS questionnaire	preoperative
evolution of patient quality of life, through OSAS questionnaire	immediately postoperative
evolution of patient quality of life, through OSAS questionnaire	minimum 15 years postoperative
evaluation of hard and soft head and neck tissue, according to cone-beam CT imaging	minimum 15 years postoperative

Collaborators and Investigators

• Sponsor: AZ Sint-Jan AV
• Collaborators: University Hospital, Ghent
• Investigators: Principal Investigator: Nathalie Neyt, AZ Sint-Jan Brugge-Oostende AV

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: February 10, 2017
• First Submitted That Met QC Criteria: August 7, 2017
• First Posted (Actual): August 11, 2017

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 13, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: quality of life; long-term results; maxillomandibular advancement osteotomy; polysomnographic measurements; skeletal stability
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 2016/0876

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No