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Oral Appliance Therapy in Obstructive Sleep Apnea

This study has been completed.
Sponsor:
Information provided by:
VU University of Amsterdam
ClinicalTrials.gov Identifier:
NCT00950495
First received: July 30, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted

July 30, 2009
July 30, 2009
October 2003
Not Provided
apnea-hypopnea index (AHI) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
other respiratory variables (apnea-hypopnea index during different sleep stages and positions);sleep variables (sleep stages and arousals);excessive daytime sleepiness;health perception;compliance;snoring reports; side-effects [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Oral Appliance Therapy in Obstructive Sleep Apnea
Effects of an Oral Appliance on Obstructive Sleep Apnea: A Randomized, Placebo-Controlled Trial

The aim of the study was to compare the effects of a mandibular advancement device (MAD) with those of nasal continuous positive airway pressure(nCPAP) and of an intra-oral placebo device in obstructive sleep apnea (OSA) patients. The hypothesis for this study was that both MAD therapy and nCPAP therapy have similar, better treatment effects than placebo therapy in OSA. The study was performed according to the CONSORT (consolidated standards of reporting trials) statement (Altman et al., 2001), employing a parallel-group, randomized, placebo-controlled trial design

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Obstructive Sleep Apnea
  • Device: Mandibular Advancement Device (MAD)
    Mandibular Advancement Device (MAD) is an oral appliance that protrudes the mandible during sleep so that unobstructed breathing becomes possible, reducing and/or preventing apneas and hypopneas
  • Device: nasal Continuous Positive Airway Pressure (nCPAP)
    The CPAP machine delivers a stream of compressed air via a hose to a nose mask, splinting the airway (keeping it open under air pressure) so that unobstructed breathing becomes possible, reducing and/or preventing apneas and hypopneas
  • Device: intra-oral placebo appliance
    as a placebo, a thin (< 1 mm), hard acrylic-resin palatal splint with only a partial palatal coverage was used
  • Active Comparator: Mandibular Advancement Device (MAD)
    Intervention: Device: Mandibular Advancement Device (MAD)
  • Active Comparator: nasal Continuous Positive Airway Pressure (nCPAP)
    Intervention: Device: nasal Continuous Positive Airway Pressure (nCPAP)
  • Placebo Comparator: intra-oral placebo-appliance
    Intervention: Device: intra-oral placebo appliance

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
July 2009
Not Provided

Inclusion Criteria:

  • age > 18 years
  • apnea-hypopnea index (AHI) between 5 and 45 events per hour

Exclusion Criteria:

  • evidence of respiratory/ sleep disorders other than obstructive sleep apnea
  • a body mass index (BMI) > 40
  • medication usage that could influence respiration or sleep
  • periodic limb movement disorder
  • previous treatment with CPAP or MAD
  • reversible morphological upper airway abnormalities (e.g., enlarged tonsils)
  • temporomandibular disorders (based on a functional examination of the masticatory system)
  • untreated periodontal problems
  • dental pain
  • lack of retention possibilities for a mandibular advancement device or a placebo appliance
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00950495
U/1731/0326
Yes
Ghizlane Aarab, Academic Centre for Dentistry Amsterdam (ACTA), Research Institute Move, University of Amsterdam and VU University Amsterdam
VU University of Amsterdam
Not Provided
Principal Investigator: Ghizlane Aarab, DDS Academic Centre for Dentistry Amsterdam (ACTA), Research Institute Move, University of Amsterdam and VU University Amsterdam
VU University of Amsterdam
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP