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

Obstructive Sleep Apnea Clinical Trial

— MIMOSA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03246477
• Other study ID #: 2016/0876
• Status: Completed
• Start date: September 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: February 2019
• Source: AZ Sint-Jan AV
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
AZ Sint-Jan AV	University Hospital, Ghent

Outcome

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