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Oral Appliance Therapy in Obstructive Sleep Apnea

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ClinicalTrials.gov Identifier: NCT00950495
Recruitment Status : Completed
First Posted : July 31, 2009
Last Update Posted : December 25, 2014
Information provided by (Responsible Party):
Ghizlane Aarab, VU University of Amsterdam

Tracking Information
First Submitted Date  ICMJE July 30, 2009
First Posted Date  ICMJE July 31, 2009
Last Update Posted Date December 25, 2014
Study Start Date  ICMJE October 2003
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2009)
apnea-hypopnea index (AHI) [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2009)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Oral Appliance Therapy in Obstructive Sleep Apnea
Official Title  ICMJE Effects of an Oral Appliance on Obstructive Sleep Apnea: A Randomized, Placebo-Controlled Trial
Brief Summary 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.
Detailed Description

Setting and participants:

Eligible OSA patients, living in the greater Amsterdam area, were referred to the Slotervaart Medical Center by their family physician. All patients underwent a thorough medical examination, including a full polysomnographic (PSG) recording, at the departments of Neurology, Pulmonary Medicine, and ENT, as well as a thorough dental examination at the Department of Oral Kinesiology of ACTA. OSA patients were invited for participation in this study when they fulfilled the inclusion criteria and exclusion criteria.

Randomisation and allocation:

After written informed consent was obtained, the patients were randomly allocated to one of three therapy groups (MAD, nCPAP, or placebo; see below). To ensure that the groups were of approx. the same size, block randomisation was used. Block sizes were 6, 12, and 18; sizes were randomly varied. The allocation sequence was automatically generated and subsequently concealed by an independent co-worker, who kept a paper copy in a lockable drawer. Sealed opaque envelopes were used to conceal the allocation from the principal investigator.

Interventions and blinding:

Three forms of therapy interventions were used in this parallel-group study. First, an individually fabricated MAD with an adjustable protrusive mandibular position at a constant vertical dimension was used. Second, nCPAP of the REMstar Pro system was used (Respironics, Herrsching, Germany). Third, a thin (< 1 mm), hard acrylic-resin palatal splint with only a partial palatal coverage was used as a placebo.

Patients were blinded to the nature of the assigned therapy (placebo or active). After evaluating the therapy, all patients were asked if they were of the opinion that they had received an active or placebo treatment. Blinding of the analyst was ascertained by assigning codes to data sets and by analyzing these sets in random blocks.


From all patients, two full polysomnographic (PSG) recordings were obtained in the sleep laboratory of the Slotervaart Medical Center, using Siesta hardware and Pro-Fusion software (Compumedics, Abbotsford, Australia): one before therapy assignment (baseline PSG) and one after 6 ± 2 months (mean ± SD) of treatment (therapy evaluation PSG). For the MAD and nCPAP groups, the third and fourth PSG recordings for therapy evaluation were performed 6 months and one year after the first therapy evaluation (long-term follow-up). The primary and secondary outcome measures were obtained at baseline and at therapy evaluations.

The MAD and nCPAP were titrated before the start of the treatment. The titration of the nCPAP was performed during a third sleep laboratory examination. The pressure was increased in incremental steps of 1 cm H2O/h, until respiratory disturbances and respiration-related arousals were reduced to ≤ 5/h, and snoring was minimized.

For the titration of the MAD, four ambulatory PSG recordings were obtained at regular intervals, using Monet hardware and Rembrandt Software (Medcare Automation B.V., Amsterdam, The Netherlands). The most effective protrusion position of the MAD (i.e., the mandibular position that yielded the lowest AHI value) was chosen from among four randomly offered positions (viz., 0%, 25%, 50%, and 75% of the maximum protrusion).

For the placebo group, the study procedure was made equally intense as that for the MAD group by making four ambulatory PSG recordings at regular intervals as well.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Obstructive Sleep Apnea
Intervention  ICMJE
  • Device: Mandibular Advancement Device (MAD)
    This oral appliance keeps the mandible and the tongue in a protruded position. This results in an upper respiratory tract widening and/or reduced collapsibility of the upper airway, thereby preventing the upper airway collapse during sleep.
    Other Names:
    • mandibular repositioning appliance
    • mandibular advancement appliance
    • mandibular repositioning device
    • mandibular repositioning splint
    • mandibular advancement splint
    • oral appliance
  • Device: nasal CPAP
    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: placebo
    as a placebo, a thin (< 1 mm), hard acrylic-resin palatal splint with only a partial palatal coverage was used
Study Arms  ICMJE
  • Active Comparator: Mandibular advancement device (MAD)
    an MAD is placed in the mouth prior to sleep. After waking up in the morning, the appliance is removed.
    Intervention: Device: Mandibular Advancement Device (MAD)
  • Active Comparator: nasal CPAP
    The device is turned on, and the nasal mask is placed on the nose prior to sleep. After waking up in the morning, the device is turned off and the mask is removed
    Intervention: Device: nasal CPAP
  • Placebo Comparator: placebo
    the placebo appliance is placed in the mouth prior to sleep. After waking up in the morning, the appliance is removed.
    Intervention: Device: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 30, 2009)
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00950495
Other Study ID Numbers  ICMJE U/1731/0326
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Ghizlane Aarab, VU University of Amsterdam
Original Responsible Party Ghizlane Aarab, Academic Centre for Dentistry Amsterdam (ACTA), Research Institute Move, University of Amsterdam and VU University Amsterdam
Current Study Sponsor  ICMJE VU University of Amsterdam
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ghizlane Aarab, DDS Academic Centre for Dentistry Amsterdam (ACTA), Research Institute Move, University of Amsterdam and VU University Amsterdam
PRS Account VU University of Amsterdam
Verification Date December 2014

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