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

Sponsor

AZ Sint-Jan AV (Other)

Overall Status

Completed

CT.gov ID

NCT03246477

Collaborator

University Hospital, Ghent (Other)

Enrollment

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea

Study Design

Study Type:

Observational

Actual Enrollment :

12 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Sep 1, 2016

Actual Primary Completion Date :

Dec 31, 2017

Actual Study Completion Date :

Dec 31, 2017

Outcome Measures

Primary Outcome Measures

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

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]