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RecruitingNCT06386341QOMASUpdated Apr 26, 2024

QoL in OSA patiënts Treated With MMA Surgery.

An observational study in Sleep Apnea, Obstructive and Quality of Life, sponsored by Diakonessenhuis, Utrecht. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-26.

Sponsored by Diakonessenhuis, Utrecht · Observational

From the registry’s dates

  • Started Aug 2023; still recruiting 3 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
18 Years and older
Sex
All
01

Study summary

The aim of this observational study is to evaluate the impact of maxillomandibular advancement surgery on the quality of life in patients treated with obstructive sleep apnea.

The main question it aims to answer is:

Does MMA surgery in OSA patiënts improve their quality of life?

Patients will answer online surverys about their QoL and there will be data collected like length, weight and blood pressure.

Read the detailed description

The aim of this study is to evaluate the impact of MMA surgery on the quality of life of patients with obstructive sleep apnea.

It was hypnotized that MMA does not result in a significant improvement in the quality of life in patients with OSA.

The main objective is the SF-36 questionnaire The secondary objectives are the; OHIP-14, ESS, FOSQ, EQ-5D-3L and OQLQ

Design: observational study

Study population: 80 Patients who qualify for MMA above the age of 18

The patients will be recruited at the departments of Oral and Maxillofacial surgery. Individuals who match the next inclusion and exclusion criteria will be the population base of this study.There will also be a control group.These patients will have the same inclusion and exclusion criteria next to the diagnosis with OSA. The control group will be a group of patients without OSA.

Inclusion criteria for this research are:

  • 18 years and older.
  • Ability to speak, read and write Dutch.
  • Ability to follow up.
  • Ability to use a mobile device with internet connection for the online questionnaires.
  • Diagnosis with OSA. (only for the intervention group)
  • Expected to maintain current lifestyle (sports, medicine, diet etc.).
  • Qualifies for MMA surgery
  • Patients who provide informed consent

Exclusion criteria for this research:

  • Patients who do not qualify for MMA surgery
  • Medication used/ related to sleeping disorders.
  • Night or shifting work.
  • Severe chronic heart failure.
  • Medical history of known causes of tiredness by day or severe sleep disruption (insomnia,
  • PLMS, Narcolepsy).
  • Seizure disorder.
  • Known medical history of mental retardation, memory disorders or psychiatric disorders.
  • Patients with old type of pacemakers (It is possible that old types of peacemakers are not
  • Compatible with the electromagnetic radiation of the electronics of the SPT).
  • Shoulder, neck and back complaints.
  • Reversible morphological upper airway abnormalities (e.g. enlarged tonsils).
  • Inability to provide informed consent.
  • Simultaneous use of other treatment modalities to treat OSA.
  • Previous treatment for OSA with MRA or SPT
  • Pregnancy.
  • patients under the age of 18
  • Patients with mild or no OSA at all (if patient meets this criteria they will be part of the control group)

In total there will be 80 patients included.

There will be no intervention done for the purpose of this study. But the intervention that will be observed is how the MMA effects the Quality of Life of the patients who underwent this surgery. We are going to prospective observe them and follow them up through their procedure.

The responsible researcher will introduce the research to the patients. When patients meet the inclusion criteria they will be asked to participate in the research. The decision regarding participation in the study, which is made by the patient, is entirely voluntary. Patients are given two weeks time to consider joining the study population. Refusal of participation will have no consequences for further treatment of the patient. They will be asked to sign informed consent.

02

Conditions studied

  • Sleep Apnea, Obstructive
  • Quality of Life

Keywords

  • Sleep Apnea, Obstructive
  • Quality of Life
  • Surgery, Oral
03

In context

Apnea

1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.

This study's planned enrollment of 80 is below the median of 106 across 386 observational studies indexed under Apnea.

Browse Apnea studies →

Lead sponsor

Diakonessenhuis, Utrecht is the lead sponsor of 8 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients undergoing maxillomandibular advancement surgery for OSA (intervention group) or other reasons (control group).

Inclusion criteria

  • 18 years and older.
  • Ability to speak, read and write Dutch.
  • Ability to follow up.
  • Ability to use a computer with internet connection and windows-software for uploading data
  • and online questionnaires.
  • Diagnosis with OSA. (only for the intervention group)
  • Expected to maintain current lifestyle (sports, medicine, diet etc.).
  • Qualifies for MMA surgery
  • Patients who provide informed consent

Exclusion criteria

Exclusion Criteria:

  • Patients who do not qualify for MMA surgery
  • Medication used/ related to sleeping disorders.
  • Night or shifting work.
  • Severe chronic heart failure.
  • Medical history of known causes of tiredness by day or severe sleep disruption (insomnia,
  • PLMS, Narcolepsy).
  • Seizure disorder.
  • Known medical history of mental retardation, memory disorders or psychiatric disorders.
  • Patients with old type of pacemakers (It is possible that old types of peacemakers are not
  • Compatible with the electromagnetic radiation of the electronics of the SPT).
  • Shoulder, neck and back complaints.
  • Reversible morphological upper airway abnormalities (e.g. enlarged tonsils).
  • Inability to provide informed consent.
  • Simultaneous use of other treatment modalities to treat OSA.
  • Previous treatment for OSA with MRA or SPT
  • Pregnancy.
  • patients under the age of 18
  • Patients with mild or no OSA at all
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (estimated)
Target follow-up
3 Years
Patient registry
Yes

Groups and cohorts

  • Intervention group

    Patiënts who underwent MMA surgery for OSA.

    Procedure: Maxillomandibular Advancement Surgery

  • Control group

    Patiënts who underwent MMA surgery for other reasons than OSA.

    Procedure: Maxillomandibular Advancement Surgery

Interventions

  • ProcedureMaxillomandibular Advancement Surgery

    Surgery where the upper and lower jaw are repositioned.

06

What researchers measure

Primary outcomes

  1. SF-36

    Survey

    Time frame: 5 minutes

Secondary outcomes

  1. OHIP-14

    Survey

    Time frame: 5 minutes

  2. ESS

    Survey

    Time frame: 5 minutes

  3. FOSQ

    Survey

    Time frame: 5 minutes

  4. EQ-5D-3L

    Survey

    Time frame: 5 minutes

  5. OQLQ

    Survey

    Time frame: 5 minutes

07

Study locations

1 of 1 sites recruiting
  • Diakonessenhuis
    Utrecht, 3582KE, Netherlands
    • Susanne Leij · Contact · sleij@diakhuis.nl · 088-250 6172
    • Maurits de Ruiter, MD, DDS, PHD · Principal investigator
    • Haya Al-Bayyati · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06386341
Lead sponsor
Diakonessenhuis, Utrecht
Responsible party
Sponsor
First posted
Apr 26, 2024
Start date
Aug 2, 2023
Primary completion
Aug 2, 2026 (estimated)
Completion
Aug 2, 2026 (estimated)
Last update
Apr 26, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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