Oral Appliance Therapy in Obstructive Sleep Apnea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ghizlane Aarab, VU University of Amsterdam
ClinicalTrials.gov Identifier:
NCT00950495
First received: July 30, 2009
Last updated: December 24, 2014
Last verified: December 2014
  Purpose

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.


Condition Intervention
Obstructive Sleep Apnea
Device: Mandibular Advancement Device (MAD)
Device: nasal CPAP
Device: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Effects of an Oral Appliance on Obstructive Sleep Apnea: A Randomized, Placebo-Controlled Trial

Resource links provided by NLM:


Further study details as provided by VU University of Amsterdam:

Primary Outcome Measures:
  • apnea-hypopnea index (AHI) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 64
Study Start Date: October 2003
Study Completion Date: July 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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
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
Placebo Comparator: placebo
the placebo appliance is placed in the mouth prior to sleep. After waking up in the morning, the appliance is removed.
Device: placebo
as a placebo, a thin (< 1 mm), hard acrylic-resin palatal splint with only a partial palatal coverage was used

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00950495

Locations
Netherlands
Academic Centre for Dentistry Amsterdam (ACTA), Research Institute Move, University of Amsterdam and VU University Amsterdam
Amsterdam, Netherlands, 1066 EA
Sponsors and Collaborators
VU University of Amsterdam
Investigators
Principal Investigator: Ghizlane Aarab, DDS Academic Centre for Dentistry Amsterdam (ACTA), Research Institute Move, University of Amsterdam and VU University Amsterdam
  More Information

Publications:
Responsible Party: Ghizlane Aarab, Dr., VU University of Amsterdam
ClinicalTrials.gov Identifier: NCT00950495     History of Changes
Other Study ID Numbers: U/1731/0326
Study First Received: July 30, 2009
Last Updated: December 24, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by VU University of Amsterdam:
Parallel design
Oral appliance
Mandibular advancement device
Continuous positive airway pressure
Placebo
Therapy
Side-effects
Compliance

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

ClinicalTrials.gov processed this record on September 02, 2015