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

This study is currently recruiting participants.
Verified August 2012 by University Hospital, Antwerp
Sponsor:
Information provided by (Responsible Party):
Ethisch Comité UZ Antwerpen, University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT01666886
First received: August 14, 2012
Last updated: August 23, 2012
Last verified: August 2012
History of Changes
  Purpose

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

Study Type: Interventional
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.

Resource links provided by NLM:

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

Further study details as provided by University Hospital, Antwerp:

Primary Outcome Measures:
  • Polysomnographic efficacy [ Designated as safety issue: No ]
    Polysomnographic re-evaluation of the severity of sleep apnea (apnea/hypopnea index).


Estimated Enrollment: 40
Study Start Date: August 2012
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: August 14, 2012
Last Updated: August 23, 2012
Health Authority: Belgium: Ethics Committee

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

ClinicalTrials.gov processed this record on June 17, 2013