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

Completed

• Conditions: Obstructive Sleep Apnea

• Registration Number: NCT03246477
• Lead Sponsor: AZ Sint-Jan AV

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2017-02-10
• Study First Submitted QC: 2017-08-07
• Study First Posted: 2017-08-11
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-13
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Evolution of apnea-hypopnea index, as determined through polysomnography	immediately postoperative
Stability of hard and soft head and neck tissue, according to manual anthropometry	min 15 years 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
evolution of patient quality of life, through Epworth Sleepiness Scale	minimum 15 years postoperative
oxygen saturation values, as determined through polysomnography	immediately postoperative