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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03246477

Acronym

MIMOSA

Enrollment

Registered

2017-08-11

Start date

2016-09-30

Completion date

2017-12-31

Last updated

2019-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

maxillomandibular advancement osteotomy, long-term results, quality of life, polysomnographic measurements, skeletal stability

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

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

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

Outcome results