The Effect of Occlusal Splints on Respiratory Variables in Obstructive Sleep Apnea (OSA) Patients
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Obstructive Sleep Apnea |
Device: Occlusal splints |
Phase 1 |
| Study Type: | Interventional |
| 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 ]
| Enrollment: | 10 |
| 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
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- - All patients invited should be at least 18 years old.
- OSA patients, diagnosis based on a baseline polysomnographic recording (at the hospital) with AHI values until 30 (mild+ moderate OSAS).
- Adequate retention in the dentition for an occlusal stabilization splint (OSS).
Exclusion Criteria:
- - Medicine usage that influence sleep (eg Benzodiazepines).
- BMI more than 40
- Unhealthy dentition.
- Severe bruxers
- TMD patients
Contacts and Locations| Netherlands | |
| Academical Center for dentistry Amsterdam (ACTA) | |
| Amsterdam, Netherlands, 1066EA | |
| Study Chair: | Frank Lobbezoo, professor | Academic Centre for Dentistry in Amsterdam |
More Information
No publications provided
| Responsible Party: | Maria Nikolopoulou, ACTA |
| ClinicalTrials.gov Identifier: | NCT01004692 History of Changes |
| Other Study ID Numbers: | NL23988.048.08, METC 0832 |
| Study First Received: | October 29, 2009 |
| Last Updated: | October 29, 2009 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
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 Salicylic Acid Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Keratolytic Agents Dermatologic Agents |
ClinicalTrials.gov processed this record on May 16, 2013