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

NCT ID: NCT03246477

Last Updated: 2019-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-12-31

Brief Summary

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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

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Conditions

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Obstructive Sleep Apnea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role collaborator

AZ Sint-Jan AV

OTHER

Sponsor Role lead

Responsible Party

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Nathalie Neyt

maxillofacial surgeon, principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nathalie Neyt

Role: PRINCIPAL_INVESTIGATOR

AZ Sint-Lucas Brugge

Other Identifiers

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2016/0876

Identifier Type: -

Identifier Source: org_study_id

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