The Effect of Occlusal Splints on Respiratory Variables in Obstructive Sleep Apnea (OSA) Patients
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.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Effect of Occlusal Splints on Sleep and Respiratory Variables of OSA Patients|
- The main study parameter/ endpoint is the Apnoea-Hypopnoea Index (AHI) value [ Time Frame: from all 6 nights ] [ Designated as safety issue: Yes ]
- The secondary study parameter is the Epworth Sleepiness Scale (ESS) [ Time Frame: from all 6 nights ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2008|
|Estimated Study Completion Date:||June 2010|
|Estimated Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Device: Occlusal splints
Please refer to this study by its ClinicalTrials.gov identifier: NCT01004692
|Academical Center for dentistry Amsterdam (ACTA)|
|Amsterdam, Netherlands, 1066EA|
|Study Chair:||Frank Lobbezoo, professor||Academic Centre for Dentistry in Amsterdam|