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

Tracking Information

First Received Date ^ICMJE

July 30, 2009

Last Updated Date

July 30, 2009

Start Date ^ICMJE

October 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Obstructive Sleep Apnea

Intervention ^ICMJE

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

Study Arm (s)

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

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

Enrollment ^ICMJE

Completion Date

July 2009

Primary Completion Date

Not Provided

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT Number ^ICMJE

NCT00950495

Other Study ID Numbers ^ICMJE

U/1731/0326

Has Data Monitoring Committee

Yes

Responsible Party

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

Study Sponsor ^ICMJE

VU University of Amsterdam

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

Information Provided By

VU University of Amsterdam

Verification Date

July 2009

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

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