Sleep Apnea SyndromesPhase 2/3NCT00243139
Mandibular Advancement Device for Obstructive Sleep Apnea
A Phase 2/3 study testing Mandibular advancement device (activator) in people with Sleep Apnea Syndromes and Sleep Apnea, run by Nykøbing Falster County Hospital at 1 site in Denmark.
Trial summary
The purpose of this study was to determine how effective a custom-made standard dental splint (activator) advancing the lower jaw forward is in treatment of obstructive sleep apnea, and further to find factors for identification of those patients likely to benefit from this treatment. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive Sleep Apnea
- What is being tested?
- Mandibular advancement device (activator)
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 1999to Feb 2004
- Phase
- Phase 2/3
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AHI > 5 on polysomnography
- sufficient set of teeth to hold a splint
- written informed consent
Who cannot join
- sleep apnea with severe cardiovascular disease
- other severe somatic or psychiatric disease
- periodontal disease
- significant occlusal dysfunction
- pregnant women
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Nykoebing Falster County Hospital
Nykoebing Falster, Storstrøms County, DK-4800
About this study
Official title: A Randomized Controlled Trial of a Mandibular Advancement Device for Obstructive Sleep Apnea
The purpose of this study was to determine how effective a custom-made standard dental splint (activator) advancing the lower jaw forward is in treatment of obstructive sleep apnea, and further to find factors for identification of those patients likely to benefit from this treatment.
Read the detailed description
Obstructive sleep apnea (OSA) is far the most common sleep disordered breathing, affecting 2-4% of the adult population. The repetitive obstructions are located in the pharyngeal airway, leading to sleep fragmentation and resulting in excessive daytime sleepiness with consequences for ability to work, road safety and quality of life. Furthermore, OSA is an independant riskfactor for cardiovascular disease. The treatment of choice today is continuous positive airway pressure (CPAP) but a main problem with CPAP is an unsatisfactory compliance. An alternative conservative more user-friendly treatment could be oral appliances, intending to increase the pharyngeal airway directly by tongue retaining devices or indirectly by mandibular advancing devices. Though several randomized studies on oral appliances have come recent years, all giving some evidence for effect on OSA, they all had some shortcomings, such as using crossover design, small sample sizes, under-reporting of methods and data and lack of blinding.
In this study of a mandibular advancement device was used a parallel group design with an inactive device and no intervention as controls. Beside the effect on sleep, daytime sleepiness and quality of life, the study aimed to find objective factors to be used as predictors of the outcome.
- Conditions
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive Sleep Apnea
- Being tested
- Mandibular advancement device (activator)
- Keywords
- Oral appliances, Obstructive sleep apnea, Epworth Sleepiness Scale, SF-36
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandibular advancement device (activator)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sleep parameters, especially apnea-hypopnea index (AHI).
Secondary outcomes (2)
Change in daytime sleepiness, assessed by Epworth Sleepiness Scale.
Change in quality of life, assessed by SF-36.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2005 (estimated)
- Study startJul 1999
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea SyndromesStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- Nykøbing Falster County Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Center of Expertise, Oringe Psychiatric Hospital,Vordingborg, Denmark
- Investigators
- Niels Petri, MD, Principal investigator, Nykoebing Falster County Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00243139
- Sponsor's protocol ID
- SNB01
- Status last verified
- Sep 2006
- First submitted
- 20 Oct 2005
- Last updated
- 15 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Mandibular Advancement Device for Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT00243139
- Acronym / sponsor ID
- SNB01
- Conditions
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive Sleep Apnea
- Keywords
- Oral appliances, Obstructive sleep apnea, Epworth Sleepiness Scale, SF-36
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants
- Lead sponsor
- Nykøbing Falster County HospitalUniversity, hospital or other
- Collaborators
- University of Copenhagen, Center of Expertise, Oringe Psychiatric Hospital,Vordingborg, Denmark
- Study start
- Jul 1999
- Study completion
- Feb 2004
- First posted
- 21 Oct 2005 (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.
The purpose of this study was to determine how effective a custom-made standard dental splint (activator) advancing the lower jaw forward is in treatment of obstructive sleep apnea, and further to find factors for identification of those patients likely to benefit from this treatment.
Detailed description
Obstructive sleep apnea (OSA) is far the most common sleep disordered breathing, affecting 2-4% of the adult population. The repetitive obstructions are located in the pharyngeal airway, leading to sleep fragmentation and resulting in excessive daytime sleepiness with consequences for ability to work, road safety and quality of life. Furthermore, OSA is an independant riskfactor for cardiovascular disease. The treatment of choice today is continuous positive airway pressure (CPAP) but a main problem with CPAP is an unsatisfactory compliance. An alternative conservative more user-friendly treatment could be oral appliances, intending to increase the pharyngeal airway directly by tongue retaining devices or indirectly by mandibular advancing devices. Though several randomized studies on oral appliances have come recent years, all giving some evidence for effect on OSA, they all had some shortcomings, such as using crossover design, small sample sizes, under-reporting of methods and data and lack of blinding.
In this study of a mandibular advancement device was used a parallel group design with an inactive device and no intervention as controls. Beside the effect on sleep, daytime sleepiness and quality of life, the study aimed to find objective factors to be used as predictors of the outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- AHI > 5 on polysomnography
- sufficient set of teeth to hold a splint
- written informed consent
Key exclusion criteria (5 listed)
- sleep apnea with severe cardiovascular disease
- other severe somatic or psychiatric disease
- periodontal disease
- significant occlusal dysfunction
- pregnant women
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 |
|---|---|---|
| Mandibular advancement device (activator) | Device | – |
Primary outcome
Change in sleep parameters, especially apnea-hypopnea index (AHI).
2 secondary outcomes
Change in daytime sleepiness, assessed by Epworth Sleepiness Scale.
Change in quality of life, assessed by SF-36.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2006.
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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.
Niels Petri, MD principal investigator
Nykoebing Falster County Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Mandibular advancement device (activator) in people with Sleep Apnea Syndromes and Sleep Apnea, run by Nykøbing Falster County Hospital at 1 site in Denmark.
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: finished, as of the sponsor's last update on 15 Sep 2006. 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 Denmark. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in sleep parameters, especially apnea-hypopnea index (AHI).. 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 15 Sep 2006.