QoL in OSA patiënts Treated With MMA Surgery. (QOMAS)

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

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Sleep Apnea, Obstructive
• Intervention / Treatment: Procedure: Maxillomandibular Advancement Surgery

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.

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

Study Locations

• Netherlands
  • Utrecht, Netherlands, 3582KE
    • Recruiting
    • Diakonessenhuis
    • Contact: Susanne Leij; Phone Number: 088-250 6172; Email: sleij@diakhuis.nl
    • Principal Investigator: Maurits de Ruiter, MD, DDS, PHD
    • Sub-Investigator: Haya Al-Bayyati

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intervention group; Patiënts who underwent MMA surgery for OSA.	Procedure: Maxillomandibular Advancement Surgery; Surgery where the upper and lower jaw are repositioned.
Control group; Patiënts who underwent MMA surgery for other reasons than OSA.	Procedure: Maxillomandibular Advancement Surgery; Surgery where the upper and lower jaw are repositioned.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SF-36	Survey	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OHIP-14	Survey	5 minutes
ESS	Survey	5 minutes
FOSQ	Survey	5 minutes
EQ-5D-3L	Survey	5 minutes
OQLQ	Survey	5 minutes

Collaborators and Investigators

• Sponsor: Diakonessenhuis, Utrecht

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2023
• Primary Completion (Estimated): August 2, 2026
• Study Completion (Estimated): August 2, 2026

Study Registration Dates

• First Submitted: April 23, 2024
• First Submitted That Met QC Criteria: April 23, 2024
• First Posted (Actual): April 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Quality of Life; Sleep Apnea, Obstructive; Surgery, Oral
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: W23.154

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No