Sleep Apnea SyndromesNCT00477009
Effects From a Mandibular Repositioning Appliance in Patients With Obstructive Sleep Apnea and Snoring
A study testing Mandibular repositioning appliance, adjustable in people with Sleep Apnea Syndromes and Snoring, run by Umeå University at 1 site in Sweden.
Trial summary
The purpose of this study is to evaluate effects from a mandibular repositioning appliance on obstructive sleep apneas, symptoms, blood pressure and markers of stress, inflammation and cardiovascular health in patients with mild to moderate obstructive sleep apnea/hypopnea syndrome and in patients with symptomatic… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Sleep Apnea Syndromes, Snoring, Disorders of Excessive Somnolence
- What is being tested?
- Mandibular repositioning appliance, adjustable
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteSweden
- Study dates
- May 2007to Dec 2011
- Phase
- Interventional
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obstructive sleep apnea, apnea-hypopnea index of <30 with excessive daytime sleepiness
- Snoring with excessive daytime sleepiness, apnea-hypopnea index of <5
- Body mass index of <35
Who cannot join
- Unable to give informed consent
- Psychiatric disorders including dementia that may interfere with the study protocol
- Other concomitant diseases that demand acute, effective treatment of sleep apnea
- Pharyngeal soft tissue abnormalities
- Living to far away from the University Hospital
- Professional drivers
Show all 12Show fewer
- Pregnancy
- Included in other studies
- Other sleep apnea treatments
- Severe craniomandibular disorders
- Acute or advanced periodontal disease
- Insufficient number of teeth
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Depts of Respiratory Medicine and Orthodontics, Umeå University
Umeå, SE-906 51
About this study
Official title: A Randomized Controlled Trial of Effects From a Mandibular Advancement Device in Patients With Obstructive Sleep Apnea and Snoring
The purpose of this study is to evaluate effects from a mandibular repositioning appliance on obstructive sleep apneas, symptoms, blood pressure and markers of stress, inflammation and cardiovascular health in patients with mild to moderate obstructive sleep apnea/hypopnea syndrome and in patients with symptomatic snoring.
Read the detailed description
Mandibular repositioning appliances for the treatment of snoring and sleep apneas are increasingly used over the world, although the number of prescriptions of this therapy varies between countries. The appliance widens the upper airways during sleep in order to reduce sleep-disordered breathing. The device is easy to use and has become popular among patients. Despite this, the evidence for effects of this treatment is not very strong and based on only a few studies. The aim of this study is therefore to test the hypothesis that a mandibular repositioning appliance reduces sleep apneas, daytime sleepiness and other sleep apnea symptoms and increases the quality of life in sleepy patients with mild to moderate obstructive sleep apnea and in patients with symptomatic snoring. Secondary outcomes include effects on headaches, blood pressure and markers of stress, inflammation, cardiovascular health and oxidative stress. At baseline and after 4 month's treatment, the patients will respond to questionnaires about symptoms and quality of life. They will undergo measurements of sleepiness, sleep apneas and blood pressure as well as sampling of saliva, urine and blood. Factors that predict a successful treatment outcome will be analyzed in order to more exactly clarify the indications for this treatment modality in a group of patients who have been suggested to benefit from mandibular repositioning appliances according to previous studies and reviews.
- Being tested
- Mandibular repositioning appliance, adjustable
- Keywords
- Sleep apnea syndromes, Snoring, Mandibular advancement, Activator appliances, Disorders of excessive somnolence, Blood pressure, Inflammation, Oxidative stress, Hormones, Markers of Metabolic Syndrome X
- Medical subject headings
- Sleep Apnea Syndromes, Snoring, Disorders of Excessive Somnolence, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandibular repositioning appliance, adjustableDevice
Also called Herbst appliance
Comparison between mandibular repositioning appliance for nightly use and a placebo device regarding effects on sleep apneas and daytime symptoms as well as blood pressure and markers of oxidative stress and sleepiness.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Adjustable mandibular repositioning appliance Receives: Device: Mandibular repositioning appliance, adjustable |
| 2 | Placebo comparator | Placebo device in upper jaw Receives: Device: Mandibular repositioning appliance, adjustable |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep apnea and sleep measured by polysomnography
Measured: Baseline and after 4 months
Daytime sleepiness and sleep apnea symptoms assessed in questionnaires and objective testing
Measured: Baseline and after 4 months
Quality of life
Measured: Baseline and after 4 months
Secondary outcomes (8)
Headaches
Measured: Baseline and after 4 months
Blood pressure
Measured: Baseline and after 4 months
Vigilance
Measured: Baseline and after 4 months
Markers of stress
Measured: Baseline and after 4 months
Markers of inflammation
Measured: Baseline and after 4 months
Markers of cardiovascular health and oxidative stress
Measured: Baseline and after 4 months
Side-effects from the treatment
Measured: After 4 months treatment
Predictors of effects on symptoms and sleep apneas
Measured: After 4 months treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2007 (estimated)
- Study startMay 2007
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea SyndromesStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council
- Responsible party
- Principal investigator, Marie Marklund, Umeå University
- Investigators
- Marie Marklund, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00477009
- Sponsor's protocol ID
- K2007-70X-20517-01-3
- Other IDs
- Dnr 07-032M
- Status last verified
- Jan 2013
- First submitted
- 21 May 2007
- Last updated
- 18 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Marklund M, Stenlund H, Franklin KA. Mandibular advancement devices in 630 men and women with obstructive sleep apnea and snoring: tolerability and predictors of treatment success. Chest. 2004 Apr;125(4):1270-8. doi: 10.1378/chest.125.4.1270.
PubMed 15078734Lim J, Lasserson TJ, Fleetham J, Wright J. Oral appliances for obstructive sleep apnoea. Cochrane Database Syst Rev. 2006 Jan 25;2006(1):CD004435. doi: 10.1002/14651858.CD004435.pub3.
PubMed 16437488Rietz H, Franklin KA, Carlberg B, Sahlin C, Marklund M. Nocturnal Blood Pressure Is Reduced by a Mandibular Advancement Device for Sleep Apnea in Women: Findings From Secondary Analyses of a Randomized Trial. J Am Heart Assoc. 2018 Jun 21;7(13):e008642. doi: 10.1161/JAHA.118.008642.
PubMed 29929990Marklund M, Carlberg B, Forsgren L, Olsson T, Stenlund H, Franklin KA. Oral Appliance Therapy in Patients With Daytime Sleepiness and Snoring or Mild to Moderate Sleep Apnea: A Randomized Clinical Trial. JAMA Intern Med. 2015 Aug;175(8):1278-85. doi: 10.1001/jamainternmed.2015.2051.
PubMed 26030264
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Effects From a Mandibular Advancement Device in Patients With Obstructive Sleep Apnea and Snoring
- ClinicalTrials.gov ID
- NCT00477009
- Acronym / sponsor ID
- K2007-70X-20517-01-3
- Keywords
- Sleep apnea syndromes, Snoring, Mandibular advancement, Activator appliances, Disorders of excessive somnolence, Blood pressure, Inflammation, Oxidative stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- The Swedish Research Council
- Study start
- May 2007
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 22 May 2007 (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 is to evaluate effects from a mandibular repositioning appliance on obstructive sleep apneas, symptoms, blood pressure and markers of stress, inflammation and cardiovascular health in patients with mild to moderate obstructive sleep apnea/hypopnea syndrome and in patients with symptomatic snoring.
Detailed description
Mandibular repositioning appliances for the treatment of snoring and sleep apneas are increasingly used over the world, although the number of prescriptions of this therapy varies between countries. The appliance widens the upper airways during sleep in order to reduce sleep-disordered breathing. The device is easy to use and has become popular among patients. Despite this, the evidence for effects of this treatment is not very strong and based on only a few studies. The aim of this study is therefore to test the hypothesis that a mandibular repositioning appliance reduces sleep apneas, daytime sleepiness and other sleep apnea symptoms and increases the quality of life in sleepy patients with mild to moderate obstructive sleep apnea and in patients with symptomatic snoring. Secondary outcomes include effects on headaches, blood pressure and markers of stress, inflammation, cardiovascular health and oxidative stress. At baseline and after 4 month's treatment, the patients will respond to questionnaires about symptoms and quality of life. They will undergo measurements of sleepiness, sleep apneas and blood pressure as well as sampling of saliva, urine and blood. Factors that predict a successful treatment outcome will be analyzed in order to more exactly clarify the indications for this treatment modality in a group of patients who have been suggested to benefit from mandibular repositioning appliances according to previous studies and reviews.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Mandibular repositioning appliance, adjustableAdjustable mandibular repositioning appliance |
| 2 | Placebo comparator | Device: Mandibular repositioning appliance, adjustablePlacebo device in upper jaw |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Obstructive sleep apnea, apnea-hypopnea index of <30 with excessive daytime sleepiness
- Snoring with excessive daytime sleepiness, apnea-hypopnea index of <5
- Body mass index of <35
Key exclusion criteria (12 listed)
- Unable to give informed consent
- Psychiatric disorders including dementia that may interfere with the study protocol
- Other concomitant diseases that demand acute, effective treatment of sleep apnea
- Pharyngeal soft tissue abnormalities
- Living to far away from the University Hospital
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 repositioning appliance, adjustableAlso: Herbst applianceComparison between mandibular repositioning appliance for nightly use and a placebo device regarding effects on sleep apneas and daytime symptoms as well as blood pressure and markers of oxidative stress and sleepiness. | Device | 1, 2 |
Primary outcome
Sleep apnea and sleep measured by polysomnography
Time frame: Baseline and after 4 months
Daytime sleepiness and sleep apnea symptoms assessed in questionnaires and objective testing
Time frame: Baseline and after 4 months
Quality of life
Time frame: Baseline and after 4 months
8 secondary outcomes
Headaches
Time frame: Baseline and after 4 months
Blood pressure
Time frame: Baseline and after 4 months
Vigilance
Time frame: Baseline and after 4 months
Markers of stress
Time frame: Baseline and after 4 months
Markers of inflammation
Time frame: Baseline and after 4 months
Markers of cardiovascular health and oxidative stress
Time frame: Baseline and after 4 months
Side-effects from the treatment
Time frame: After 4 months treatment
Predictors of effects on symptoms and sleep apneas
Time frame: After 4 months treatment
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 18 Jan 2013.
- Background: PubMed 15078734Marklund M, Stenlund H, Franklin KA. Mandibular advancement devices in 630 men and women with obstructive sleep apnea and snoring: tolerability and predictors of treatment success. Chest. 2004 Apr;125(4):1270-8. doi: 10.1378/chest.125.4.1270.
- Background: PubMed 16437488Lim J, Lasserson TJ, Fleetham J, Wright J. Oral appliances for obstructive sleep apnoea. Cochrane Database Syst Rev. 2006 Jan 25;2006(1):CD004435. doi: 10.1002/14651858.CD004435.pub3.
- Derived from this study: PubMed 29929990Rietz H, Franklin KA, Carlberg B, Sahlin C, Marklund M. Nocturnal Blood Pressure Is Reduced by a Mandibular Advancement Device for Sleep Apnea in Women: Findings From Secondary Analyses of a Randomized Trial. J Am Heart Assoc. 2018 Jun 21;7(13):e008642. doi: 10.1161/JAHA.118.008642.
- Derived from this study: PubMed 26030264Marklund M, Carlberg B, Forsgren L, Olsson T, Stenlund H, Franklin KA. Oral Appliance Therapy in Patients With Daytime Sleepiness and Snoring or Mild to Moderate Sleep Apnea: A Randomized Clinical Trial. JAMA Intern Med. 2015 Aug;175(8):1278-85. doi: 10.1001/jamainternmed.2015.2051.
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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.
Marie Marklund principal investigator
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mandibular repositioning appliance, adjustable in people with Sleep Apnea Syndromes and Snoring, run by Umeå University at 1 site in Sweden.
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 12 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 18 Jan 2013. 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 Sweden. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Sleep apnea and sleep measured by polysomnography (time frame: Baseline and after 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00477009, which also lists 4 linked publications.
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 18 Jan 2013.