Obstructive Sleep ApneaNCT00213434
Evaluation of a Mandibular Advancement Device in the Treatment of Obstructive Sleep Apnea Syndrome
A study testing Herbst oral appliance in people with Obstructive Sleep Apnea, run by University Hospital, Rouen at 1 site in France.
Trial summary
The purpose of this study is to determine if the mandibular advancement by Herbst device is effective in the treatment of moderate obstructive sleep apnea patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Herbst oral appliance
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- Not given
- Where
- 1 siteFrance
- Study dates
- Nov 2001to Jun 2006
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate sleep apnea syndrome (10 < Respiratory Disorder Index < 30)
- Body mass index (BMI) < 35 Kg/m2
- Able to give their informed consent
Who cannot join
- Pregnant women
- Professional drivers requiring continuous positive airway pressure (CPAP) treatment
- Psychiatric disorders, and patients unable to realise to study
- Severe respiratory pathology which could interfere with the study
- Morpheic epilepsy
- Benzodiazepines intake
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- Chronic nasal obstruction
- Ear, nose, and throat (ENT) pathology requiring surgery
- Previous uvulopalatoplasty surgery
- Temporomandibular joint pathology
- Gum disease
- Insufficient number of teeth to apply the oral appliance
- Mobile teeth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Evaluation of Mandibular Advancement by Herbst Device in the Treatment of Moderate Obstructive Sleep Apnea Syndrome
The purpose of this study is to determine if the mandibular advancement by Herbst device is effective in the treatment of moderate obstructive sleep apnea patients.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Herbst oral appliance
- Keywords
- prospective, randomized, polysomnography, orthodontic appliance, removable
- 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.
Herbst oral applianceDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of polysomnographic data after 3 months of treatment by oral appliance in 2 groups: one with Herbst device adjusted in maximal mandibular advancement and a placebo group
Secondary outcomes (4)
Efficacy on clinical symptoms
Tolerance of the oral appliance
Identification of predictive factors of efficacy
Feasibility of this therapeutic method
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startNov 2001
- Primary completionDec 2004
- Study completionJun 2006
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.
- More trials run by University Hospital, RouenThe 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
- Double blind
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- PORTIER PF Florence, MD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00213434
- Sponsor's protocol ID
- 2000/055/HP
- Status last verified
- Jun 2013
- First submitted
- 13 Sep 2005
- Last updated
- 26 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Mandibular Advancement by Herbst Device in the Treatment of Moderate Obstructive Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT00213434
- Acronym / sponsor ID
- 2000/055/HP
- Conditions
- Obstructive Sleep Apnea
- Keywords
- prospective, randomized, polysomnography, orthodontic appliance, removable
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Nov 2001
- Primary completion
- Dec 2004 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 21 Sep 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 is to determine if the mandibular advancement by Herbst device is effective in the treatment of moderate obstructive sleep apnea patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Moderate sleep apnea syndrome (10 < Respiratory Disorder Index < 30)
- Body mass index (BMI) < 35 Kg/m2
- Able to give their informed consent
Key exclusion criteria (13 listed)
- Pregnant women
- Professional drivers requiring continuous positive airway pressure (CPAP) treatment
- Psychiatric disorders, and patients unable to realise to study
- Severe respiratory pathology which could interfere with the study
- Morpheic epilepsy
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 |
|---|---|---|
| Herbst oral appliance | Device | – |
Primary outcome
Comparison of polysomnographic data after 3 months of treatment by oral appliance in 2 groups: one with Herbst device adjusted in maximal mandibular advancement and a placebo group
4 secondary outcomes
Efficacy on clinical symptoms
Tolerance of the oral appliance
Identification of predictive factors of efficacy
Feasibility of this therapeutic method
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 26 Jun 2013.
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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.
PORTIER PF Florence, MD principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Herbst oral appliance in people with Obstructive Sleep Apnea, run by University Hospital, Rouen at 1 site in France.
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 13 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 26 Jun 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 France. 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.
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?
Comparison of polysomnographic data after 3 months of treatment by oral appliance in 2 groups: one with Herbst device adjusted in maximal mandibular advancement and a placebo group. 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 26 Jun 2013.