NCT00950495

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 31, 2009

Completed
Last Updated

December 25, 2014

Status Verified

December 1, 2014

Enrollment Period

5.3 years

First QC Date

July 30, 2009

Last Update Submit

December 24, 2014

Conditions

Obstructive Sleep Apnea

Keywords

Parallel designOral applianceMandibular advancement deviceContinuous positive airway pressurePlaceboTherapySide-effectsCompliance

Outcome Measures

Primary Outcomes (1)

  • apnea-hypopnea index (AHI)

    6 months

Secondary Outcomes (1)

  • 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

    6 months

Study Arms (3)

Mandibular advancement device (MAD)

ACTIVE COMPARATOR

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)

nasal CPAP

ACTIVE COMPARATOR

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

placebo

PLACEBO COMPARATOR

the placebo appliance is placed in the mouth prior to sleep. After waking up in the morning, the appliance is removed.

Device: placebo

Interventions

Mandibular Advancement Device (MAD)DEVICE

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.

Also known as: mandibular repositioning appliance, mandibular advancement appliance, mandibular repositioning device, mandibular repositioning splint, mandibular advancement splint, oral appliance
Mandibular advancement device (MAD)
nasal CPAPDEVICE

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

nasal CPAP
placeboDEVICE

as a placebo, a thin (\< 1 mm), hard acrylic-resin palatal splint with only a partial palatal coverage was used

placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Centre for Dentistry Amsterdam (ACTA), Research Institute Move, University of Amsterdam and VU University Amsterdam

Amsterdam, 1066 EA, Netherlands

Location

Related Publications (6)

  • Aarab G, Lobbezoo F, Hamburger HL, Naeije M. Effects of an oral appliance with different mandibular protrusion positions at a constant vertical dimension on obstructive sleep apnea. Clin Oral Investig. 2010 Jun;14(3):339-45. doi: 10.1007/s00784-009-0298-9. Epub 2009 Jun 18.

    PMID: 19536571RESULT

  • Aarab G, Lobbezoo F, Hamburger HL, Naeije M. Variability in the apnea-hypopnea index and its consequences for diagnosis and therapy evaluation. Respiration. 2009;77(1):32-7. doi: 10.1159/000167790. Epub 2008 Oct 29.

    PMID: 18957843RESULT

  • Aarab G, Lobbezoo F, Wicks DJ, Hamburger HL, Naeije M. Short-term effects of a mandibular advancement device on obstructive sleep apnoea: an open-label pilot trial. J Oral Rehabil. 2005 Aug;32(8):564-70. doi: 10.1111/j.1365-2842.2005.01467.x.

    PMID: 16011634RESULT

  • Aarab G, Lobbezoo F, Hamburger HL, Naeije M. Oral appliance therapy versus nasal continuous positive airway pressure in obstructive sleep apnea: a randomized, placebo-controlled trial. Respiration. 2011;81(5):411-9. doi: 10.1159/000319595. Epub 2010 Oct 20.

    PMID: 20962502RESULT

  • Aarab G, Lobbezoo F, Heymans MW, Hamburger HL, Naeije M. Long-term follow-up of a randomized controlled trial of oral appliance therapy in obstructive sleep apnea. Respiration. 2011;82(2):162-8. doi: 10.1159/000324580. Epub 2011 Mar 31.

    PMID: 21454959RESULT

  • Nikolopoulou M, Naeije M, Aarab G, Hamburger HL, Visscher CM, Lobbezoo F. The effect of raising the bite without mandibular protrusion on obstructive sleep apnoea. J Oral Rehabil. 2011 Sep;38(9):643-7. doi: 10.1111/j.1365-2842.2011.02221.x. Epub 2011 Apr 5.

    PMID: 21463349RESULT

MeSH Terms

Conditions

Sleep Apnea, ObstructivePatient Compliance

Interventions

Occlusal Splints

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Orthotic DevicesOrthopedic EquipmentSurgical EquipmentEquipment and Supplies

Study Officials

  • Ghizlane Aarab, DDS

    Academic Centre for Dentistry Amsterdam (ACTA), Research Institute Move, University of Amsterdam and VU University Amsterdam

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

July 30, 2009

First Posted

July 31, 2009

Study Start

October 1, 2003

Primary Completion

January 1, 2009

Study Completion

July 1, 2009

Last Updated

December 25, 2014

Record last verified: 2014-12

Locations

NL(1)