Efficacy of Additional Titration During Oral Appliance Treatment for Sleep-disordered Breathing.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01666886|
Recruitment Status : Unknown
Verified June 2013 by Ethisch Comité UZ Antwerpen, University Hospital, Antwerp.
Recruitment status was: Recruiting
First Posted : August 16, 2012
Last Update Posted : June 20, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea Syndrome||Device: Mandibular Advancement Device (MAD)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Additional Titration During Oral Appliance Treatment for Sleep-disordered Breathing.|
|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)
- Polysomnographic efficacyPolysomnographic re-evaluation of the severity of sleep apnea (apnea/hypopnea index).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|