Obstructive Sleep ApneaPhase 1NCT01004692
The Effect of Occlusal Splints on Respiratory Variables in Obstructive Sleep Apnea (OSA) Patients
A Phase 1 study testing Occlusal splints in people with Obstructive Sleep Apnea, run by Academic Centre for Dentistry in Amsterdam at 1 site in Netherlands.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Occlusal splints
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2008to Jun 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - 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).
Who cannot join
- - Medicine usage that influence sleep (eg Benzodiazepines).
- BMI more than 40
- Unhealthy dentition.
- Severe bruxers
- TMD patients
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Academical Center for dentistry Amsterdam (ACTA)
Amsterdam, 1066EA
About this study
Official title: The Effect of Occlusal Splints on Sleep and Respiratory Variables of OSA Patients
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.
Read more
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Occlusal splints
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occlusal splintsDevice
Also called occlusal stabilisation splint
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
The main study parameter/ endpoint is the Apnoea-Hypopnoea Index (AHI) value
Measured: from all 6 nights
Secondary outcomes (1)
The secondary study parameter is the Epworth Sleepiness Scale (ESS)
Measured: from all 6 nights
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2009 (estimated)
- Study startDec 2008
- Primary completionJan 2010 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academic Centre for Dentistry in Amsterdam
- Sponsor type
- University, hospital or other
- Investigators
- Frank Lobbezoo, professor, Study chair, Academic Centre for Dentistry in Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01004692
- Sponsor's protocol ID
- NL23988.048.08
- Other IDs
- METC 0832
- Status last verified
- Oct 2009
- First submitted
- 29 Oct 2009
- Last updated
- 30 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Occlusal Splints on Sleep and Respiratory Variables of OSA Patients
- ClinicalTrials.gov ID
- NCT01004692
- Acronym / sponsor ID
- NL23988.048.08
- Conditions
- Obstructive Sleep Apnea
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Academic Centre for Dentistry in AmsterdamUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Jan 2010 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 30 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- - 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).
Key exclusion criteria (5 listed)
- - Medicine usage that influence sleep (eg Benzodiazepines).
- BMI more than 40
- Unhealthy dentition.
- Severe bruxers
- TMD patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occlusal splintsAlso: occlusal stabilisation splintThe 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. | Device | – |
Primary outcome
The main study parameter/ endpoint is the Apnoea-Hypopnoea Index (AHI) value
Time frame: from all 6 nights
1 secondary outcome
The secondary study parameter is the Epworth Sleepiness Scale (ESS)
Time frame: from all 6 nights
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Lobbezoo, professor study chair
Academic Centre for Dentistry in Amsterdam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Occlusal splints in people with Obstructive Sleep Apnea, run by Academic Centre for Dentistry in Amsterdam at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The main study parameter/ endpoint is the Apnoea-Hypopnoea Index (AHI) value (time frame: from all 6 nights). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2009.