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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Academic Centre for Dentistry in Amsterdam
ClinicalTrials.gov Identifier:
NCT01004692
First received: October 29, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  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

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

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 April 17, 2014