Oral Appliance Therapy in Obstructive Sleep Apnea - Full Text View

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	Phase
Obstructive Sleep Apnea	Device: Mandibular Advancement Device (MAD) Device: nasal Continuous Positive Airway Pressure (nCPAP) Device: intra-oral placebo appliance	Phase 2

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:

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

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

Arms	Assigned Interventions
Active Comparator: Mandibular Advancement Device (MAD)	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
Active Comparator: nasal Continuous Positive Airway Pressure (nCPAP)	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
Placebo Comparator: intra-oral placebo-appliance	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

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

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:

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. 2009 Jun 18; [Epub ahead of print]

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. Epub 2008 Oct 29.

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.

Responsible Party:	Ghizlane Aarab, Academic Centre for Dentistry Amsterdam (ACTA), Research Institute Move, University of Amsterdam and VU University Amsterdam
ClinicalTrials.gov Identifier:	NCT00950495 History of Changes
Other Study ID Numbers:	U/1731/0326
Study First Received:	July 30, 2009
Last Updated:	July 30, 2009
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
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory

Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 21, 2013