The Effect of Occlusal Splints on Respiratory Variables in Obstructive Sleep Apnea (OSA) Patients
|ClinicalTrials.gov Identifier: NCT01004692|
Recruitment Status : Unknown
Verified October 2009 by Academic Centre for Dentistry in Amsterdam.
Recruitment status was: Enrolling by invitation
First Posted : October 30, 2009
Last Update Posted : October 30, 2009
Rationale: The effect of vertical dimension on sleep apnoea and respiratory variables in obstructive sleep apnoea patients.
Objective: To what extend should a possible worsening of the OSA condition, caused by an increase of mouth opening be taken into consideration in daily dental practice, when an occlusal stabilization splint (OSS) is placed in the mouth.
Study design: Cross over RCT-design Study population: OSA patients referred to ACTA from the Slotervaart Hospital, for treatment with a Mandibular Advancement Device (MAD), at least 18 years old.
Intervention: Occlusal stabilization splint (OSS) for the upper jaw and a controlled condition in a cross-over design Main study parameters/endpoints: Apnoea- Hypopnoea Index (AHI) and the Epworth Sleepiness Scale (ESS).
The aim of this study is to determine the effect of vertical dimension of OS on sleep and respiratory variables in OSA patients. The hypothesis is that insertion of an OSS and an increase of the vertical dimension will result in a significant increase in the AHI.
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea||Device: Occlusal splints||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effect of Occlusal Splints on Sleep and Respiratory Variables of OSA Patients|
|Study Start Date :||December 2008|
|Estimated Primary Completion Date :||January 2010|
|Estimated Study Completion Date :||June 2010|
- Device: Occlusal splints
The splint will be a hard acrylic-resin stabilization appliance to wear in the upper jaw. The OSS does not come in contact with the gums of the patient and does not act as an orthodontic device. The OSS will be used only for the three nights in a row, of the ambulatory-PSG recording with the OSS in situ.Other Name: occlusal stabilisation splint
- The main study parameter/ endpoint is the Apnoea-Hypopnoea Index (AHI) value [ Time Frame: from all 6 nights ]
- The secondary study parameter is the Epworth Sleepiness Scale (ESS) [ Time Frame: from all 6 nights ]
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): NCT01004692
|Academical Center for dentistry Amsterdam (ACTA)|
|Amsterdam, Netherlands, 1066EA|
|Study Chair:||Frank Lobbezoo, professor||Academic Centre for Dentistry in Amsterdam|