Long-term Impact of Maxillomandibular Advancement Osteotomy on Sleep Apnea Patients (MIMOSA)
Evaluation of the Long-term Impact of Maxillomandibular Advancement Osteotomy on Patients With Obstructive Sleep Apnea Syndrome
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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
apnea-hypopnea index, as determined through polysomnography
Tidsramme: minimum 15 years postoperative
|
minimum 15 years postoperative
|
|
oxygen saturation values, as determined through polysomnography
Tidsramme: minimum 15 years postoperative
|
minimum 15 years postoperative
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
evolution of patient quality of life, through Epworth Sleepiness Scale
Tidsramme: preoperative
|
preoperative
|
|
Stability of hard and soft head and neck tissue, according to manual anthropometry
Tidsramme: min 15 years postoperative
|
min 15 years postoperative
|
|
Evolution of apnea-hypopnea index, as determined through polysomnography
Tidsramme: preoperative
|
preoperative
|
|
Evolution of apnea-hypopnea index, as determined through polysomnography
Tidsramme: immediately postoperative
|
immediately postoperative
|
|
oxygen saturation values, as determined through polysomnography
Tidsramme: preoperative
|
preoperative
|
|
oxygen saturation values, as determined through polysomnography
Tidsramme: immediately postoperative
|
immediately postoperative
|
|
evolution of patient quality of life, through Epworth Sleepiness Scale
Tidsramme: immediately postoperative
|
immediately postoperative
|
|
evolution of patient quality of life, through Epworth Sleepiness Scale
Tidsramme: minimum 15 years postoperative
|
minimum 15 years postoperative
|
|
evolution of patient quality of life, through OSAS questionnaire
Tidsramme: preoperative
|
preoperative
|
|
evolution of patient quality of life, through OSAS questionnaire
Tidsramme: immediately postoperative
|
immediately postoperative
|
|
evolution of patient quality of life, through OSAS questionnaire
Tidsramme: minimum 15 years postoperative
|
minimum 15 years postoperative
|
|
evaluation of hard and soft head and neck tissue, according to cone-beam CT imaging
Tidsramme: minimum 15 years postoperative
|
minimum 15 years postoperative
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Nathalie Neyt, AZ Sint-Jan Brugge-Oostende AV
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2016/0876
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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