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

NCT03246477 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2019-02-15

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • University Hospital, Ghent

    collaborator OTHER

  • AZ Sint-Jan AV

    lead OTHER

Principal Investigators

  • Nathalie Neyt · AZ Sint-Lucas Brugge

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-12-31
Completion
2017-12-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03246477 on ClinicalTrials.gov