An observational study in Obstructive Sleep Apnea, sponsored by AZ Sint-Jan AV. Completed. Per ClinicalTrials.gov, last updated 2019-02-15.
Sponsored by AZ Sint-Jan AV · Observational
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.
2,263 studies on the registry are indexed under Sleep Apnea, Obstructive; 465 are open to participants now.
This study's enrollment of 12 is below the median of 105 across 666 observational studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →AZ Sint-Jan AV is the lead sponsor of 60 studies on the registry; 14 are open to participants now.
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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)
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Exclusion Criteria:
apnea-hypopnea index, as determined through polysomnography
Time frame: minimum 15 years postoperative
oxygen saturation values, as determined through polysomnography
Time frame: minimum 15 years postoperative
evolution of patient quality of life, through Epworth Sleepiness Scale
Time frame: preoperative
Stability of hard and soft head and neck tissue, according to manual anthropometry
Time frame: min 15 years postoperative
Evolution of apnea-hypopnea index, as determined through polysomnography
Time frame: preoperative
Evolution of apnea-hypopnea index, as determined through polysomnography
Time frame: immediately postoperative
oxygen saturation values, as determined through polysomnography
Time frame: preoperative
oxygen saturation values, as determined through polysomnography
Time frame: immediately postoperative
evolution of patient quality of life, through Epworth Sleepiness Scale
Time frame: immediately postoperative
evolution of patient quality of life, through Epworth Sleepiness Scale
Time frame: minimum 15 years postoperative
evolution of patient quality of life, through OSAS questionnaire
Time frame: preoperative
evolution of patient quality of life, through OSAS questionnaire
Time frame: immediately postoperative
evolution of patient quality of life, through OSAS questionnaire
Time frame: minimum 15 years postoperative
evaluation of hard and soft head and neck tissue, according to cone-beam CT imaging
Time frame: minimum 15 years postoperative
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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AZ Sint-Jan AV