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
  Hide Detailed Description

Detailed Description:

Mild or Moderate OSA patients (AHI 10-30) referred by Slotervaart Hospital, to ACTA, for treatment with an MAD. Both males and females will participate in the study. All participants will be over 18 years old.

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 An occlusal stabilization splint (OSS) will be constructed for each patient, as an intervention device. 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.

After written informed consent will be obtained, the patients will be randomly allocated to one of the two groups. To ensure that the groups would be of approx. the same size, block randomization will be used. Block sizes will be used and sizes will vary randomly. The allocation sequence will automatically be generated and subsequently concealed by an independent co-worker, who will keep a paper copy in a lockable drawer.

All patients will be referred to ACTA, by the Center for sleep wake disorders at Slotervaart Hospital. There they will have done a PSG-sleep study. The PSG recording will take place in a dark hospital room, in the Slotervaart Hospital in Amsterdam, at the department of Clinical Neurophysiology (The multidisciplinary Centre for Sleep-Wake Disorders). OSA patients with diagnosis mild and moderate OSA will be invited to participate in the trial.

Following the PSG recording and the diagnosis at Slotervaart Hospital, each patient will come for a first appointment, at the department of Oral Function, section of Oral Kinesiology, at ACTA. Medical and dental history will be obtained. If the patients fulfill the inclusion criteria and agree to participate in the study, impressions of the upper and lower jaw, Body Mass Index (BMI), neck circumference, and the Epworth Sleepiness Scale will be obtained.

The medical history will be obtained by using questionnaires, the dental history by using questionnaires, clinical dental examination, and OPG x-ray (orthopantomogram). The BMI will be obtained by measuring the height and the weight of the patient. (BMI = kg/ cm ²). The neck circumference will be measured in cm. Impressions with alginate and a wax-index with dental wax will be taken for every patient, in order to make the dental casts for the construction of the splints. The whole procedure will last approximately 1 hour.

The patients will be randomly divided in two groups. The patients will be randomly placed in the two groups. The patients will undergo the PSG-recordings without the OSS in situ and the nights with the OSS in situ, in a cross-over design.

Group 1: The patients will undergo 3 nights of home-PSG recording without the OSS in situ first. 2 weeks later they will undergo 3 nights of PSG-recording with the OSS in situ.

Group 2: The patients in Group 2 will first undergo 3 nights of ambulatory PSG-recording with the OSS in situ. 2 weeks later they will undergo 3 nights of home-PSG recording without the OSS in situ.

Appointments will be made either for the OSS placement at ACTA or for the mounting of the equipment for the ambulatory recording, at Slotervaart hospital, depending on in which group the patient will be randomly placed.

Group 1: The mounting of the equipment for the ambulatory recording will take place at the department of Clinical Neurophysiology at Slotervaart Hospital. The procedure will last approximately 1 hour. The Monet hardware (Medcare, Amsterdam, The Netherlands) with 19 recording channels will be used for the recordings and the Rembrandt software will be used for the analysis.

The patient will sleep at home with the ambulatory PSG equipment 3 nights in a row, without the OSS in situ. That means that 3 mounting appointments will be held at the department of Clinical Neurophysiology at Slotervaart Hospital, 3 afternoons in a row.

Every morning after the home PSG-recording, the patients will take off the electrodes themselves at home (using a solution that we will provide them with, in order to resolve the glue) and they will have to bring the equipment back to ACTA.

In the meantime (between the first and the second visit to ACTA), an OSS for the upper jaw will be constructed for every patient. The OSS will be constructed at the same dental laboratory for all patients. It will be made by hard acrylic resin and no palatal coverage will be made.

The patients will come back to ACTA after 1 week (second appointment) for the placement of the splint (OSS). On the second appointment at ACTA the OSS will be placed.

The patients will wear the OSS, in order to get used to it, under the period of one week and after that they will undergo 3 nights of ambulatory sleep recording with the OSS in situ.

Group 2: The patients will come back to ACTA after 1 week (second appointment at ACTA) for the placement of the splint (OSS).

The patients will wear the OSS, in order to get used to it, under the period of one week and after that they will undergo 3 nights of ambulatory sleep recording with the OSS in situ.

The mounting of the equipment for the ambulatory recording will take place at the department of Clinical Neurophysiology at Slotervaart Hospital. The procedure will last approximately 1 hour. The Monet hardware (Medcare, Amsterdam, The Netherlands) with 19 recording channels will be used for the recordings and the Rembrandt software will be used for the analysis.

The patients will sleep at home with the ambulatory PSG equipment 3 days in a row, with the OSS in situ. That means that 3 mounting appointments will be held at the department of Clinical Neurophysiology at Slotervaart Hospital, 3 afternoons in a row.

Every morning after the home PSG-recording, the patients will take off the electrodes themselves at home (using a solution that we will provide them with, in order to resolve the glue) and they will have to bring the equipment back to ACTA.

Two weeks later, the patients that belong in the 2nd group, will undergo 3 ambulatory recordings at home, without the OSS in situ.

All patients will have to fill in 10 questionnaires at the beginning of the study and at the end of the study. The ESS and the "morning- questionnaire" and the evening- questionnaire" will be filled by all patients between nights as well. That means in the beginning, at the end of the study and in the 6 days while having the home- PSG recordings.

Following the last home PSG recording the below mentioned data will be collected (for all patients, belonging to both groups):

  • Body Mass Index (BMI)
  • Neck circumference
  • The Epworth Sleepiness Scale
  • Side effects of the splints (OSS).

The main study parameter/ endpoint is the Apnoea-Hypopnoea Index (AHI) value. The secondary study parameter is the Epworth Sleepiness Scale (ESS).

The side effects of the splint (OSS) will be evaluated.

  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
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 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 August 26, 2014