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

NCT03246477 | Completed

• 1 other identifier: 2016/0876
• Study Type: observational
• Target: 12
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obstructive Sleep Apnea

Keywords

maxillomandibular advancement osteotomy; long-term results; quality of life; polysomnographic measurements; skeletal stability

Outcome Measures

Primary Outcomes (2)

• apnea-hypopnea index, as determined through polysomnography

  minimum 15 years postoperative

• oxygen saturation values, as determined through polysomnography

  minimum 15 years postoperative

Secondary Outcomes (12)

• evolution of patient quality of life, through Epworth Sleepiness Scale

  preoperative

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

  min 15 years postoperative

• Evolution of apnea-hypopnea index, as determined through polysomnography

  preoperative

• Evolution of apnea-hypopnea index, as determined through polysomnography

  immediately postoperative

• oxygen saturation values, as determined through polysomnography

  preoperative

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• clinically confirmed diagnosis of OSAS
• treated with an MMA between 01/11/1995 and 01/12/1999 by one surgeon (CDC)

You may not qualify if:

• not following abovementioned criteria

Sponsors & Collaborators

• AZ Sint-Jan AV: lead
• University Hospital, Ghent: collaborator

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Nathalie Neyt

  AZ Sint-Lucas Brugge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: maxillofacial surgeon, principal investigator

Study Record Dates

• First Submitted: February 10, 2017
• First Posted: August 11, 2017
• Study Start: September 1, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share