Completed

Efficacy of Additional Titration During Oral Appliance Treatment for Sleep-disordered Breathing.

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What is being tested

Mandibular Advancement Device (MAD)

Device
Who is being recruted

Apnea+6

+ Nervous System Diseases

+ Respiration Disorders

Over 18 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: August 2012
See protocol details

Summary

Principal SponsorUniversity Hospital, Antwerp
Last updated: January 20, 2021
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2012

Actual date on which the first participant was enrolled.

In the protocol "Predicting therapeutic outcome of mandibular advancement device treatment in obstructive sleep apnea (PROMAD)", 100 patients with obstructive sleep apnea are included and started MAD treatment at 75% of maximal protrusion. All patients underwent polysomnography with MAD in situ to evaluate the effect of the MAD on severity of sleep apnea. If the results of the polysomnography with MAD are unsuccessful (defined as a reduction in AHI with the MAD in situ of less than 50% compared to baseline), the therapy needs to be adjusted. Finding the most effective protrusion should be a weighted compromise between efficacy and side-effects of MAD therapy. In patients with insufficient results on the polysomnography with the MAD at 75% of maximal protrusion, the MAD will be further adjusted until 90% of the maximal protrusion measured at the follow-up visit after the polysomnography with the MAD. After habituation and adaptation period but within 2 months after the first polysomnography with MAD, a new polysomnography will be performed to assess the effect of the 90% protruded position.

NCT01666886
Principal SponsorUniversity Hospital, Antwerp
Last updated: January 20, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ApneaNervous System DiseasesRespiration DisordersRespiratory Tract DiseasesSleep Apnea SyndromesSleep Wake DisordersSleep Disorders, IntrinsicDyssomniasSleep Apnea, Obstructive

Criteria

5 inclusion criteria required to participate
Age >= 18 years
Body Mass Index (BMI) <= 35 kg/m^2
OSAS, as defined by the American Academy of Sleep Medicine Task Force
apnea-hypopnea index (AHI) < 50
Show More Criteria
7 exclusion criteria prevent from participating
Dental contra-indications: functional restrictions of the temporomandibular joint, insufficient dentition with pathological changes, insufficient retention for MAD use
Invasive upper airway surgery for sleep-disordered breathing
Known genetic disorders with craniofacial and/or upper airway malformations
Known history of fibromyalgia and/or chronic fatigue syndrome
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Mandibular advancement during therapy with a mandibular advancement device (MAD) in 90% of maximal protrusion

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Antwerp University Hospital

Wilrijk, BelgiumOpen Antwerp University Hospital in Google Maps
CompletedOne Study Center