Obstructive Sleep Apnea SyndromePhase 4PROMADNCT01532050
PROMAD: Predicting Therapeutic Outcome of Mandibular Advancement Device Treatment in Obstructive Sleep Apnea
A Phase 4 study testing Mandibular Advancement Device ( MAD) in people with Obstructive Sleep Apnea Syndrome, run by ethisch.comite@uza.be at 1 site in Belgium.
Trial summary
The present research intends to focus clinically on selecting the right type of patient for mandibular advancement devices (MAD) therapy using screening tools such as advanced imaging and computational methods based on CT-Scan images as well as drug-induced sleep nasendoscopy techniques with simulation of the… 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
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2012to Nov 2015
- Phase
- Phase 4
- 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
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
Official title: PROMAD : Predicting Therapeutic Outcome of Mandibular Advancement Device Treatment in Obstructive Sleep Apnea
The present research intends to focus clinically on selecting the right type of patient for mandibular advancement devices (MAD) therapy using screening tools such as advanced imaging and computational methods based on CT-Scan images as well as drug-induced sleep nasendoscopy techniques with simulation of the mandibular repositioning. The core of the research project relies on known and established methods accepted in several neighboring fields, but aims at the transfer of this knowledge by integrating it into this new domain. Doing so, the proposed biomedical research is directed towards clinical applications that incorporate innovative developments on the level of the diagnosis and therapy of a specific disease, being obstructive sleep apnea syndrome (OSAS). Furthermore, this study aims at registering objective compliance during MAD therapy.
- Conditions
- Obstructive Sleep Apnea Syndrome
- Being tested
- Mandibular Advancement Device ( MAD)
- Keywords
- OSAS, American Academy of Sleep Medicine Task Force
- 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) | Other | Mandibular Advancement Device (MAD) Receives: Device: Mandibular Advancement Device ( MAD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive value of DISE and CFD
Positive and negative predictive values for AHI based treatment outcome
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionJul 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea SyndromeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- ethisch.comite@uza.be
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ethisch.comite@uza.be, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01532050
- Sponsor's protocol ID
- IWT MRA UZA
- Acronym
- PROMAD
- Status last verified
- Jan 2021
- First submitted
- 30 Jan 2012
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Van Gaver H, Op de Beeck S, Dieltjens M, De Backer J, Verbraecken J, De Backer WA, Van de Heyning PH, Braem MJ, Vanderveken OM. Functional imaging improves patient selection for mandibular advancement device treatment outcome in sleep-disordered breathing: a prospective study. J Clin Sleep Med. 2022 Mar 1;18(3):739-750. doi: 10.5664/jcsm.9694.
PubMed 34608859Op de Beeck S, Dieltjens M, Azarbarzin A, Willemen M, Verbraecken J, Braem MJ, Wellman A, Sands SA, Vanderveken OM. Mandibular Advancement Device Treatment Efficacy Is Associated with Polysomnographic Endotypes. Ann Am Thorac Soc. 2021 Mar;18(3):511-518. doi: 10.1513/AnnalsATS.202003-220OC.
PubMed 32946702Van de Perck E, Op de Beeck S, Dieltjens M, Vroegop AV, Verbruggen AE, Willemen M, Verbraecken J, Van de Heyning PH, Braem MJ, Vanderveken OM. The relationship between specific nasopharyngoscopic features and treatment deterioration with mandibular advancement devices: a prospective study. J Clin Sleep Med. 2020 Jul 15;16(7):1189-1198. doi: 10.5664/jcsm.8474.
PubMed 32267227Op de Beeck S, Dieltjens M, Verbruggen AE, Vroegop AV, Wouters K, Hamans E, Willemen M, Verbraecken J, De Backer WA, Van de Heyning PH, Braem MJ, Vanderveken OM. Phenotypic Labelling Using Drug-Induced Sleep Endoscopy Improves Patient Selection for Mandibular Advancement Device Outcome: A Prospective Study. J Clin Sleep Med. 2019 Aug 15;15(8):1089-1099. doi: 10.5664/jcsm.7796.
PubMed 31482830Dieltjens M, Verbruggen AE, Braem MJ, Wouters K, Verbraecken JA, De Backer WA, Hamans E, Van de Heyning PH, Vanderveken OM. Determinants of Objective Compliance During Oral Appliance Therapy in Patients With Sleep-Disordered Breathing: A Prospective Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2015 Oct;141(10):894-900. doi: 10.1001/jamaoto.2015.1756.
PubMed 26402736
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
- PROMAD : Predicting Therapeutic Outcome of Mandibular Advancement Device Treatment in Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT01532050
- Acronym / sponsor ID
- PROMAD / IWT MRA UZA
- Conditions
- Obstructive Sleep Apnea Syndrome
- Keywords
- OSAS, American Academy of Sleep Medicine Task Force
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- ethisch.comite@uza.beUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 13 Feb 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.
The present research intends to focus clinically on selecting the right type of patient for mandibular advancement devices (MAD) therapy using screening tools such as advanced imaging and computational methods based on CT-Scan images as well as drug-induced sleep nasendoscopy techniques with simulation of the mandibular repositioning. The core of the research project relies on known and established methods accepted in several neighboring fields, but aims at the transfer of this knowledge by integrating it into this new domain. Doing so, the proposed biomedical research is directed towards clinical applications that incorporate innovative developments on the level of the diagnosis and therapy of a specific disease, being obstructive sleep apnea syndrome (OSAS). Furthermore, this study aims at registering objective compliance during MAD therapy.
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) | Other | Device: Mandibular Advancement Device ( MAD)Mandibular Advancement Device (MAD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 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
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
Predictive value of DISE and CFD
Time frame: 3 months
Positive and negative predictive values for AHI based treatment outcome
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.
- Derived from this study: PubMed 34608859Van Gaver H, Op de Beeck S, Dieltjens M, De Backer J, Verbraecken J, De Backer WA, Van de Heyning PH, Braem MJ, Vanderveken OM. Functional imaging improves patient selection for mandibular advancement device treatment outcome in sleep-disordered breathing: a prospective study. J Clin Sleep Med. 2022 Mar 1;18(3):739-750. doi: 10.5664/jcsm.9694.
- Derived from this study: PubMed 32946702Op de Beeck S, Dieltjens M, Azarbarzin A, Willemen M, Verbraecken J, Braem MJ, Wellman A, Sands SA, Vanderveken OM. Mandibular Advancement Device Treatment Efficacy Is Associated with Polysomnographic Endotypes. Ann Am Thorac Soc. 2021 Mar;18(3):511-518. doi: 10.1513/AnnalsATS.202003-220OC.
- Derived from this study: PubMed 32267227Van de Perck E, Op de Beeck S, Dieltjens M, Vroegop AV, Verbruggen AE, Willemen M, Verbraecken J, Van de Heyning PH, Braem MJ, Vanderveken OM. The relationship between specific nasopharyngoscopic features and treatment deterioration with mandibular advancement devices: a prospective study. J Clin Sleep Med. 2020 Jul 15;16(7):1189-1198. doi: 10.5664/jcsm.8474.
- Derived from this study: PubMed 31482830Op de Beeck S, Dieltjens M, Verbruggen AE, Vroegop AV, Wouters K, Hamans E, Willemen M, Verbraecken J, De Backer WA, Van de Heyning PH, Braem MJ, Vanderveken OM. Phenotypic Labelling Using Drug-Induced Sleep Endoscopy Improves Patient Selection for Mandibular Advancement Device Outcome: A Prospective Study. J Clin Sleep Med. 2019 Aug 15;15(8):1089-1099. doi: 10.5664/jcsm.7796.
- Derived from this study: PubMed 26402736Dieltjens M, Verbruggen AE, Braem MJ, Wouters K, Verbraecken JA, De Backer WA, Hamans E, Van de Heyning PH, Vanderveken OM. Determinants of Objective Compliance During Oral Appliance Therapy in Patients With Sleep-Disordered Breathing: A Prospective Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2015 Oct;141(10):894-900. doi: 10.1001/jamaoto.2015.1756.
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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 Phase 4 study testing Mandibular Advancement Device ( MAD) in people with Obstructive Sleep Apnea Syndrome, run by ethisch.comite@uza.be 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 4 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Predictive value of DISE and CFD (time frame: 3 months). 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 NCT01532050, which also lists 5 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 20 Jan 2021.