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The Effect of Occlusal Splints on Respiratory Variables in Obstructive Sleep Apnea (OSA) Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2009 by Academic Centre for Dentistry in Amsterdam.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01004692
First Posted: October 30, 2009
Last Update Posted: October 30, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Academic Centre for Dentistry in Amsterdam
  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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Occlusal Splints on Sleep and Respiratory Variables of OSA Patients

Resource links provided by NLM:


Further study details as provided by Academic Centre for Dentistry in Amsterdam:

Primary Outcome Measures:
  • The main study parameter/ endpoint is the Apnoea-Hypopnoea Index (AHI) value [ Time Frame: from all 6 nights ]

Secondary Outcome Measures:
  • The secondary study parameter is the Epworth Sleepiness Scale (ESS) [ Time Frame: from all 6 nights ]

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)
Intervention Details:
    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
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

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


Locations
Netherlands
Academical Center for dentistry Amsterdam (ACTA)
Amsterdam, Netherlands, 1066EA
Sponsors and Collaborators
Academic Centre for Dentistry in Amsterdam
Investigators
Study Chair: Frank Lobbezoo, professor Academic Centre for Dentistry in Amsterdam
  More Information

Responsible Party: Maria Nikolopoulou, ACTA
ClinicalTrials.gov Identifier: NCT01004692     History of Changes
Other Study ID Numbers: NL23988.048.08
METC 0832
First Submitted: October 29, 2009
First Posted: October 30, 2009
Last Update Posted: October 30, 2009
Last Verified: October 2009

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Salicylic Acid
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents