Sleep-disordered BreathingNCT01533623
The 1 Year Follow-up Objective Oral Appliance Compliance
A study testing Mandibular Advancement Device in people with Sleep-disordered Breathing, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
The investigators will perform a 1-year clinical trial measuring objective compliance during mandibular advancement device (MAD) treatment. The investigators will enroll 50 patients that received treatment with a titratable, duobloc MAD (RespiDent Butterfly®, RespiDent, Nijlen, Belgium) and participated in the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep-disordered Breathing
- What is being tested?
- Mandibular Advancement Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteBelgium
- Study dates
- Start not givento Jul 2012
- 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
- clinical diagnosis of sleep-disordered breathing
- started treatment with a titratable, duobloc mandibular advancement device
- participated in original study 10/48/340 (3 month follow-up of compliance during treatment with mandibular advancement device)
Who cannot join
- dental exclusion criteria for mandibular advancement devices
- medical contra-indications for mandibular advancement devices
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The 1 Year Follow-up of Objective Measures of Oral Appliance Compliance for Treatment of Sleep-disordered Breathing (SDB): a Clinical Trial
The investigators will perform a 1-year clinical trial measuring objective compliance during mandibular advancement device (MAD) treatment.
The investigators will enroll 50 patients that received treatment with a titratable, duobloc MAD (RespiDent Butterfly®, RespiDent, Nijlen, Belgium) and participated in the original study "Objective versus subjective compliance with oral appliance therapy for obstructive sleep apnea hypopnea syndrome", registered at Clinical Trials.gov (NCT01284881).
Read more
Active microsensors (TheraMon®,Handelsagentur Gschladt, Hargelsberg, Austria) are provided by the Handelsagentur Gschladt without any costs. The sampling interval of the recording will be done at a rate of 1 measurement per 15 minutes (every 900 seconds). Using this sample interval, the capacity of the active microsensor allows for data acquisition during a 100 day period.
A follow-up appointment is scheduled +/- 265 days after the start of the original study. A second follow-up visit is scheduled again 1 year after the start of the original study.
The objective measurement of MAD wear time (total hours of wear time and the mean hours of wear per night over the respective period) will be based on the assumption that the MAD has been worn when the chip records a temperature intraorally.
Read the detailed description
This clinical trial is an extension to trial 10/48/340, registered at Clinical Trials.gov (NCT01284881).
- Conditions
- Sleep-disordered Breathing
- Being tested
- Mandibular Advancement Device
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandibular Advancement DeviceDevice
Also called RespiDent Butterfly® Mandibular Repositioning Appliance
Nightly wearing time
| Study group | Role | What they receive |
|---|---|---|
| mandibular advancement device treatment | Other | Patients diagnosed with sleep-disordered breathing that receive treatment with a titratable, duobloc mandibular advancement devices Receives: Device: Mandibular Advancement Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and feasibility of measuring objective mean wearing time
To assess the safety and feasibility of measuring objective mean wearing time as a measure of objective oral appliance wear. The objective mean wearing time will be assessed using a microsensor thermometer. Regular follow-up visits will be performed, and patients will be questioned regarding side-effects of the microsensor.
Measured: 1 year
Secondary outcomes (1)
therapeutic index
to calculate the therapeutic index based on objective compliance and decrease in apnea-hypopnea index / disease severity
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep-disordered BreathingStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ethisch Comité UZ Antwerpen, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01533623
- Sponsor's protocol ID
- EC 11/41/291
- Status last verified
- Jun 2013
- First submitted
- 31 Jan 2012
- Last updated
- 20 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The 1 Year Follow-up of Objective Measures of Oral Appliance Compliance for Treatment of Sleep-disordered Breathing (SDB): a Clinical Trial
- ClinicalTrials.gov ID
- NCT01533623
- Acronym / sponsor ID
- EC 11/41/291
- Conditions
- Sleep-disordered Breathing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 15 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 investigators will perform a 1-year clinical trial measuring objective compliance during mandibular advancement device (MAD) treatment.
The investigators will enroll 50 patients that received treatment with a titratable, duobloc MAD (RespiDent Butterfly®, RespiDent, Nijlen, Belgium) and participated in the original study "Objective versus subjective compliance with oral appliance therapy for obstructive sleep apnea hypopnea syndrome", registered at Clinical Trials.gov (NCT01284881).
Active microsensors (TheraMon®,Handelsagentur Gschladt, Hargelsberg, Austria) are provided by the Handelsagentur Gschladt without any costs. The sampling interval of the recording will be done at a rate of 1 measurement per 15 minutes (every 900 seconds). Using this sample interval, the capacity of the active microsensor allows for data acquisition during a 100 day period.
A follow-up appointment is scheduled +/- 265 days after the start of the original study. A second follow-up visit is scheduled again 1 year after the start of the original study.
The objective measurement of MAD wear time (total hours of wear time and the mean hours of wear per night over the respective period) will be based on the assumption that the MAD has been worn when the chip records a temperature intraorally.
Detailed description
This clinical trial is an extension to trial 10/48/340, registered at Clinical Trials.gov (NCT01284881).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mandibular advancement device treatment | Other | Device: Mandibular Advancement DevicePatients diagnosed with sleep-disordered breathing that receive treatment with a titratable, duobloc mandibular advancement devices |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- clinical diagnosis of sleep-disordered breathing
- started treatment with a titratable, duobloc mandibular advancement device
- participated in original study 10/48/340 (3 month follow-up of compliance during treatment with mandibular advancement device)
Key exclusion criteria (2 listed)
- dental exclusion criteria for mandibular advancement devices
- medical contra-indications for mandibular advancement devices
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 DeviceAlso: RespiDent Butterfly® Mandibular Repositioning ApplianceNightly wearing time | Device | mandibular advancement device treatment |
Primary outcome
Safety and feasibility of measuring objective mean wearing time
Time frame: 1 year
To assess the safety and feasibility of measuring objective mean wearing time as a measure of objective oral appliance wear. The objective mean wearing time will be assessed using a microsensor thermometer. Regular follow-up visits will be performed, and patients will be questioned regarding side-effects of the microsensor.
1 secondary outcome
therapeutic index
Time frame: 1 year
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 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.
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 in people with Sleep-disordered Breathing, 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 3 inclusion and 2 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 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 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?
Safety and feasibility of measuring objective mean wearing time (time frame: 1 year). 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 Jun 2013.