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

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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
Sponsor:
Information provided by (Responsible Party):
Ethisch Comité UZ Antwerpen, University Hospital, Antwerp

Brief Summary:

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
Obstructive Sleep Apnea Syndrome Device: Mandibular Advancement Device (MAD)

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Additional Titration During Oral Appliance Treatment for Sleep-disordered Breathing.
Study Start Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arm Intervention/treatment
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)



Primary Outcome Measures :
  1. Polysomnographic efficacy
    Polysomnographic re-evaluation of the severity of sleep apnea (apnea/hypopnea index).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Marc J Braem, DDS, PhD 0032 3 821 33 89 ext +32 marc.braem@ua.ac.be
Contact: Olivier M Vanderveken, MD, PhD 0032 3 821 33 85 ext +32 olivier.vanderveken@uza.be

Locations
Belgium
Antwerp University Hospital Recruiting
Wilrijk, Antwerp, Belgium, 2650
Contact: Marc J Braem, DDS, PhD    +32 3 821 33 89 ext 0032    marc.braem@uza.ac.be   
Principal Investigator: Olivier M Vanderveken, MD, PhD         
Principal Investigator: Marc J Braem, DDS, PhD         
Sponsors and Collaborators
University Hospital, Antwerp

Responsible Party: Ethisch Comité UZ Antwerpen, Ethics Committee Antwerp Univerity Hospital, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT01666886     History of Changes
Other Study ID Numbers: EC 12/30/243
First Posted: August 16, 2012    Key Record Dates
Last Update Posted: June 20, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases