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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Efficacy of Additional Titration During Oral Appliance Treatment for Sleep-disordered Breathing.|
- Polysomnographic efficacy [ Designated as safety issue: No ]Polysomnographic re-evaluation of the severity of sleep apnea (apnea/hypopnea index).
|Study Start Date:||August 2012|
Experimental: Mandibular Advancement Device (MAD)
Mandibular advancement during therapy with a mandibular advancement device (MAD) in 90% of maximal protrusion
|Device: Mandibular Advancement Device (MAD)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01666886
|Contact: Marc J Braem, DDS, PhD||0032 3 821 33 89 ext +email@example.com|
|Contact: Olivier M Vanderveken, MD, PhD||0032 3 821 33 85 ext +firstname.lastname@example.org|
|Antwerp University Hospital||Recruiting|
|Wilrijk, Antwerp, Belgium, 2650|
|Contact: Marc J Braem, DDS, PhD +32 3 821 33 89 ext 0032 email@example.com|
|Principal Investigator: Olivier M Vanderveken, MD, PhD|
|Principal Investigator: Marc J Braem, DDS, PhD|