Obstructive Sleep ApneaNCT02763813
Comparison of Two Oral Appliances in the Treatment of Sleep Apnea Syndrome
A study testing Herbst (propulsion type oral appliance) and Retention type appliance (ORM) in people with Obstructive Sleep Apnea, run by Hopital Foch at 1 site in France.
Trial summary
Monocentric comparative group study comparing the efficacy and short-term tolerance of a propulsion type oral appliance (Herbst) with a retention type device (ORM) used in the treatment of sleep apnea syndrome. The investigators hypothesized both appliances would be equally effective and tolerated. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Herbst (propulsion type oral appliance) and Retention type appliance (ORM)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteFrance
- Study dates
- May 2010to Feb 2013
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sufficient teeth to allow wearing of the device
- Mild to severe OSAS
- Ability to answer the questionnaires
- No concomitant CPAP treatment
- BMI inferior to 32 kg/m2
Who cannot join
- Important dental or parodontal disease
- Central sleep apnea
- Jaw opening limitations
- Temporo-mandibular joint dysfunction
- Major gag reflex precluding the long-term use of the device
- Major or unstable cardiovascular or pulmonary disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of a Retention Type and Propulsion Type Oral Appliance in the Treatment of Obstructive Sleep Apnea
Monocentric comparative group study comparing the efficacy and short-term tolerance of a propulsion type oral appliance (Herbst) with a retention type device (ORM) used in the treatment of sleep apnea syndrome. The investigators hypothesized both appliances would be equally effective and tolerated.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Herbst (propulsion type oral appliance), Retention type appliance (ORM)
- 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 (propulsion type oral appliance)Device
Oral appliance
Retention type appliance (ORM)Device
| Study group | Role | What they receive |
|---|---|---|
| Propulsion type appliance (Herbst) | Experimental | Not described Receives: Device: Herbst (propulsion type oral appliance) |
| Retention type appliance (ORM) | Active comparator | Retention type appliance Receives: Device: Retention type appliance (ORM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea/hypopnea index (as measured from a level 1 or 2 polysomnography)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startMay 2010
- Primary completionDec 2012
- Study completionFeb 2013
Why it stopped: recruitment difficulties
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc BLUMEN, MD, Study chair, Hôpital FOCH 40, rue Worth 92150 Suresnes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763813
- Sponsor's protocol ID
- 2010/05
- Status last verified
- Oct 2016
- First submitted
- 19 Apr 2016
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Retention Type and Propulsion Type Oral Appliance in the Treatment of Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT02763813
- Acronym / sponsor ID
- 2010/05
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment difficulties
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 5 May 2016 (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.
Monocentric comparative group study comparing the efficacy and short-term tolerance of a propulsion type oral appliance (Herbst) with a retention type device (ORM) used in the treatment of sleep apnea syndrome. The investigators hypothesized both appliances would be equally effective and tolerated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propulsion type appliance (Herbst) | Experimental | Device: Herbst (propulsion type oral appliance) |
| Retention type appliance (ORM) | Active comparator | Device: Retention type appliance (ORM)Retention type appliance |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Sufficient teeth to allow wearing of the device
- Mild to severe OSAS
- Ability to answer the questionnaires
- No concomitant CPAP treatment
- BMI inferior to 32 kg/m2
Key exclusion criteria (6 listed)
- Important dental or parodontal disease
- Central sleep apnea
- Jaw opening limitations
- Temporo-mandibular joint dysfunction
- Major gag reflex precluding the long-term use of the device
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 (propulsion type oral appliance)Oral appliance | Device | Propulsion type appliance (Herbst) |
| Retention type appliance (ORM) | Device | Retention type appliance (ORM) |
Primary outcome
Apnea/hypopnea index (as measured from a level 1 or 2 polysomnography)
Time frame: 12 months
Results and safety
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
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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.
Marc BLUMEN, MD study chair
Hôpital FOCH 40, rue Worth 92150 Suresnes
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 (propulsion type oral appliance) and Retention type appliance (ORM) in people with Obstructive Sleep Apnea, run by Hopital Foch 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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 14 Oct 2016. 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 was stopped early (reason given: recruitment difficulties). 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?
Apnea/hypopnea index (as measured from a level 1 or 2 polysomnography) (time frame: 12 months). 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 14 Oct 2016.