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Completed

NCT Number: NCT03246477

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. apnea-hypopnea index, as determined through polysomnography

    Time frame: minimum 15 years postoperative

  2. oxygen saturation values, as determined through polysomnography

    Time frame: minimum 15 years postoperative

Secondary outcomes

  1. evolution of patient quality of life, through Epworth Sleepiness Scale

    Time frame: preoperative

  2. Stability of hard and soft head and neck tissue, according to manual anthropometry

    Time frame: min 15 years postoperative

  3. Evolution of apnea-hypopnea index, as determined through polysomnography

    Time frame: preoperative

  4. Evolution of apnea-hypopnea index, as determined through polysomnography

    Time frame: immediately postoperative

  5. oxygen saturation values, as determined through polysomnography

    Time frame: preoperative

  6. oxygen saturation values, as determined through polysomnography

    Time frame: immediately postoperative

  7. evolution of patient quality of life, through Epworth Sleepiness Scale

    Time frame: immediately postoperative

  8. evolution of patient quality of life, through Epworth Sleepiness Scale

    Time frame: minimum 15 years postoperative

  9. evolution of patient quality of life, through OSAS questionnaire

    Time frame: preoperative

  10. evolution of patient quality of life, through OSAS questionnaire

    Time frame: immediately postoperative

  11. evolution of patient quality of life, through OSAS questionnaire

    Time frame: minimum 15 years postoperative

  12. evaluation of hard and soft head and neck tissue, according to cone-beam CT imaging

    Time frame: minimum 15 years postoperative

Sponsors and collaborators

Lead sponsor

AZ Sint-Jan AV

Other

Collaborators

  • University Hospital, Ghent

Registry information

Official study title

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

Acronym: MIMOSA

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 11, 2017
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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