Clinical trial NCT03246477: Long-term Impact of Maxillomandibular Advancement Osteotomy on Sleep Apnea Patients
Official title: Evaluation of the Long-term Impact of Maxillomandibular Advancement Osteotomy on Patients With Obstructive Sleep Apnea Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Keywords: maxillomandibular advancement osteotomy
long-term results
quality of life
polysomnographic measurements
skeletal stability
Lead sponsor: AZ Sint-Jan AV
Sponsor class: OTHER
Collaborators: name: University Hospital, Ghent
First posted: 2017-08-11
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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)

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.


Eligibility criteria: 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

Primary outcomes:
measure: apnea-hypopnea index, as determined through polysomnography
timeFrame: minimum 15 years postoperative
measure: oxygen saturation values, as determined through polysomnography
timeFrame: minimum 15 years postoperative
Secondary outcomes:
measure: evolution of patient quality of life, through Epworth Sleepiness Scale
timeFrame: preoperative
measure: Stability of hard and soft head and neck tissue, according to manual anthropometry
timeFrame: min 15 years postoperative
measure: Evolution of apnea-hypopnea index, as determined through polysomnography
timeFrame: preoperative
measure: Evolution of apnea-hypopnea index, as determined through polysomnography
timeFrame: immediately postoperative
measure: oxygen saturation values, as determined through polysomnography
timeFrame: preoperative
measure: oxygen saturation values, as determined through polysomnography
timeFrame: immediately postoperative
measure: evolution of patient quality of life, through Epworth Sleepiness Scale
timeFrame: immediately postoperative
measure: evolution of patient quality of life, through Epworth Sleepiness Scale
timeFrame: minimum 15 years postoperative
measure: evolution of patient quality of life, through OSAS questionnaire
timeFrame: preoperative
measure: evolution of patient quality of life, through OSAS questionnaire
timeFrame: immediately postoperative
measure: evolution of patient quality of life, through OSAS questionnaire
timeFrame: minimum 15 years postoperative
measure: evaluation of hard and soft head and neck tissue, according to cone-beam CT imaging
timeFrame: minimum 15 years postoperative
Other outcomes:
Locations:
Study officials:
affiliation: AZ Sint-Lucas Brugge
name: Nathalie Neyt
role: PRINCIPAL_INVESTIGATOR
References: