This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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
Information provided by:
Academic Centre for Dentistry in Amsterdam Identifier:
First received: October 29, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted

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 (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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01004692

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

Responsible Party: Maria Nikolopoulou, ACTA 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

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Salicylic Acid
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents processed this record on June 26, 2017