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Obstructive Sleep ApneaMIMOSANCT03246477

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

An observational study of Obstructive Sleep Apnea, run by AZ Sint-Jan AV.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Any age
Conditions the study is for
Obstructive Sleep Apnea
How many people
12 participants
Where
No sites listed yet
Study dates
Sep 2016to 31 Dec 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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)

Who may be able to join

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

Who cannot join

  • not following abovementioned criteria

About this study

Official title: 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.

Read more

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.

Keywords
maxillomandibular advancement osteotomy, long-term results, quality of life, polysomnographic measurements, skeletal stability
Medical subject headings
Sleep Apnea, Obstructive

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. apnea-hypopnea index, as determined through polysomnography

    Measured: minimum 15 years postoperative

  2. oxygen saturation values, as determined through polysomnography

    Measured: minimum 15 years postoperative

Secondary outcomes (12)

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

    Measured: preoperative

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

    Measured: min 15 years postoperative

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

    Measured: preoperative

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

    Measured: immediately postoperative

  5. oxygen saturation values, as determined through polysomnography

    Measured: preoperative

  6. oxygen saturation values, as determined through polysomnography

    Measured: immediately postoperative

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

    Measured: immediately postoperative

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

    Measured: minimum 15 years postoperative

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

    Measured: preoperative

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

    Measured: immediately postoperative

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

    Measured: minimum 15 years postoperative

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

    Measured: minimum 15 years postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2017
  2. Study startSep 2016
  3. Primary completion31 Dec 2017
  4. Study completion31 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03246477
Sponsor's protocol ID
2016/0876
Acronym
MIMOSA
Status last verified
Feb 2019
First submitted
10 Feb 2017
Last updated
15 Feb 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Obstructive Sleep Apnea, run by AZ Sint-Jan AV.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

apnea-hypopnea index, as determined through polysomnography (time frame: minimum 15 years postoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03246477.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.

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