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NCT Number: NCT06386341

QoL in OSA patiënts Treated With MMA Surgery.

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Diakonessenhuis

Utrecht, 3582KE, Netherlands

Location status: Recruiting

Location contact

Haya Al-Bayyati

SUB_INVESTIGATOR

Maurits de Ruiter, MD, DDS, PHD

PRINCIPAL_INVESTIGATOR

Susanne Leij

CONTACT

[email protected]

088-250 6172

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Maxillomandibular Advancement Surgery

Procedure

Surgery where the upper and lower jaw are repositioned.

Primary outcomes

  1. SF-36

    Time frame: 5 minutes

    Survey

Secondary outcomes

  1. OHIP-14

    Time frame: 5 minutes

    Survey

  2. ESS

    Time frame: 5 minutes

    Survey

  3. FOSQ

    Time frame: 5 minutes

    Survey

  4. EQ-5D-3L

    Time frame: 5 minutes

    Survey

  5. OQLQ

    Time frame: 5 minutes

    Survey

Sponsors and collaborators

Lead sponsor

Diakonessenhuis, Utrecht

Other

Registry information

Official study title

Quality of Life in Obstructive Sleep Apnea patiënts Treated With Maxillomandibular Advancement Surgery.

Acronym: QOMAS

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 26, 2024
Registry last updated
Apr 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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