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
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea||Device: Mandibular Advancement Device (MAD) Device: nasal CPAP Device: placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effects of an Oral Appliance on Obstructive Sleep Apnea: A Randomized, Placebo-Controlled Trial|
|Study Start Date :||October 2003|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||July 2009|
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.
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.
as a placebo, a thin (< 1 mm), hard acrylic-resin palatal splint with only a partial palatal coverage was used
- apnea-hypopnea index (AHI) [ Time Frame: 6 months ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00950495
|Academic Centre for Dentistry Amsterdam (ACTA), Research Institute Move, University of Amsterdam and VU University Amsterdam|
|Amsterdam, Netherlands, 1066 EA|
|Principal Investigator:||Ghizlane Aarab, DDS||Academic Centre for Dentistry Amsterdam (ACTA), Research Institute Move, University of Amsterdam and VU University Amsterdam|