Obstructive Sleep Apnea SyndromeNCT01666886
Efficacy of Additional Titration During Oral Appliance Treatment for Sleep-disordered Breathing.
A study testing Mandibular Advancement Device (MAD) in people with Obstructive Sleep Apnea Syndrome, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
In the protocol "Predicting therapeutic outcome of mandibular advancement device treatment in obstructive sleep apnea (PROMAD)", 100 patients with obstructive sleep apnea are included and started MAD treatment at 75% of maximal protrusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- What is being tested?
- Mandibular Advancement Device (MAD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2012to Apr 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Body Mass Index (BMI) ≤ 35 kg/m²
- OSAS, as defined by the American Academy of Sleep Medicine Task Force
- apnea-hypopnea index (AHI) < 50
- incomplete elimination of apneas and/or hypopnea during therapy with mandibular advancement device in 75% of maximal protrusion
Who cannot join
- Other sleep disorders (i.e. parasomnias)
- Invasive upper airway surgery for sleep-disordered breathing
- Known genetic disorders with craniofacial and/or upper airway malformations
- Use of benzodiazepine and/or antidepressants
- Known history of psychiatric disease
- Known history of fibromyalgia and/or chronic fatigue syndrome
- Dental contra-indications: functional restrictions of the temporomandibular joint, insufficient dentition with pathological changes, insufficient retention for MAD use
Trial locations and contacts
1 site in 1 country.
About this study
In the protocol "Predicting therapeutic outcome of mandibular advancement device treatment in obstructive sleep apnea (PROMAD)", 100 patients with obstructive sleep apnea are included and started MAD treatment at 75% of maximal protrusion. All patients underwent polysomnography with MAD in situ to evaluate the effect of the MAD on severity of sleep apnea. If the results of the polysomnography with MAD are unsuccessful (defined as a reduction in AHI with the MAD in situ of less than 50% compared to baseline), the therapy needs to be adjusted. Finding the most effective protrusion should be a weighted compromise between efficacy and side-effects of MAD therapy.
In patients with insufficient results on the polysomnography with the MAD at 75% of maximal protrusion, the MAD will be further adjusted until 90% of the maximal protrusion measured at the follow-up visit after the polysomnography with the MAD. After habituation and adaptation period but within 2 months after the first polysomnography with MAD, a new polysomnography will be performed to assess the effect of the 90% protruded position.
- Conditions
- Obstructive Sleep Apnea Syndrome
- Being tested
- Mandibular Advancement Device (MAD)
- 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.
Mandibular Advancement Device (MAD)Device
| Study group | Role | What they receive |
|---|---|---|
| Mandibular Advancement Device (MAD) | Experimental | Mandibular advancement during therapy with a mandibular advancement device (MAD) in 90% of maximal protrusion Receives: Device: Mandibular Advancement Device (MAD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polysomnographic efficacy
Polysomnographic re-evaluation of the severity of sleep apnea (apnea/hypopnea index).
Measured: 3 to 6 months after start of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ethisch.comite@uza.be, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01666886
- Sponsor's protocol ID
- EC 12/30/243
- Status last verified
- Jan 2021
- First submitted
- 14 Aug 2012
- Last updated
- 20 Jan 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Additional Titration During Oral Appliance Treatment for Sleep-disordered Breathing.
- ClinicalTrials.gov ID
- NCT01666886
- Acronym / sponsor ID
- EC 12/30/243
- Conditions
- Obstructive Sleep Apnea Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- Aug 2012 (actual)
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 16 Aug 2012 (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.
In the protocol "Predicting therapeutic outcome of mandibular advancement device treatment in obstructive sleep apnea (PROMAD)", 100 patients with obstructive sleep apnea are included and started MAD treatment at 75% of maximal protrusion. All patients underwent polysomnography with MAD in situ to evaluate the effect of the MAD on severity of sleep apnea. If the results of the polysomnography with MAD are unsuccessful (defined as a reduction in AHI with the MAD in situ of less than 50% compared to baseline), the therapy needs to be adjusted. Finding the most effective protrusion should be a weighted compromise between efficacy and side-effects of MAD therapy.
In patients with insufficient results on the polysomnography with the MAD at 75% of maximal protrusion, the MAD will be further adjusted until 90% of the maximal protrusion measured at the follow-up visit after the polysomnography with the MAD. After habituation and adaptation period but within 2 months after the first polysomnography with MAD, a new polysomnography will be performed to assess the effect of the 90% protruded position.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mandibular Advancement Device (MAD) | Experimental | Device: Mandibular Advancement Device (MAD)Mandibular advancement during therapy with a mandibular advancement device (MAD) in 90% of maximal protrusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Body Mass Index (BMI) ≤ 35 kg/m²
- OSAS, as defined by the American Academy of Sleep Medicine Task Force
- apnea-hypopnea index (AHI) < 50
- incomplete elimination of apneas and/or hypopnea during therapy with mandibular advancement device in 75% of maximal protrusion
Key exclusion criteria (7 listed)
- Other sleep disorders (i.e. parasomnias)
- Invasive upper airway surgery for sleep-disordered breathing
- Known genetic disorders with craniofacial and/or upper airway malformations
- Use of benzodiazepine and/or antidepressants
- Known history of psychiatric disease
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 (MAD) | Device | Mandibular Advancement Device (MAD) |
Primary outcome
Polysomnographic efficacy
Time frame: 3 to 6 months after start of therapy
Polysomnographic re-evaluation of the severity of sleep apnea (apnea/hypopnea index).
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 20 Jan 2021.
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Advancement Device (MAD) in people with Obstructive Sleep Apnea Syndrome, run by University Hospital, Antwerp at 1 site in Belgium.
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 7 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 20 Jan 2021. 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 Belgium. 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?
Polysomnographic efficacy (time frame: 3 to 6 months after start of therapy). 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 20 Jan 2021.