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

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.

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Key information

Conditions

Obstructive Sleep Apnea Syndrome Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antwerp University Hospital

Wilrijk, Antwerp, 2650, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Age ≥ 18 years
Body Mass Index (BMI) ≤ 35 kg/m²
OSAS, as defined by the American Academy of Sleep Medicine Task Force
apnea-hypopnea index (AHI) < 50
incomplete elimination of apneas and/or hypopnea during therapy with mandibular advancement device in 75% of maximal protrusion

Exclusion criteria

Other sleep disorders (i.e. parasomnias)
Invasive upper airway surgery for sleep-disordered breathing
Known genetic disorders with craniofacial and/or upper airway malformations
Use of benzodiazepine and/or antidepressants
Known history of psychiatric disease
Known history of fibromyalgia and/or chronic fatigue syndrome
Dental contra-indications: functional restrictions of the temporomandibular joint, insufficient dentition with pathological changes, insufficient retention for MAD use

Treatment and study plan

Mandibular advancement device (MAD)

Device

Primary outcomes

Polysomnographic efficacy

Time frame: 3 to 6 months after start of therapy

Polysomnographic re-evaluation of the severity of sleep apnea (apnea/hypopnea index).

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2015
First posted: Aug 16, 2012
Registry last updated: Jan 20, 2021

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.

Published trials that share one or more normalized conditions with this study.

Completed