OSAHSNCT01284881
Self-Reported Versus Objective Measured Compliance With Oral Appliance Therapy for Obstructive Sleep Apnea Hypopnea Syndrome
An observational study of OSAHS, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
Oral appliances, such as Mandibular Repositioning Appliances (MRA), have emerged as a treatment option for sleep-disordered breathing (SDB). The purpose of this study is to compare active measurement of MRA compliance with patient's self-report. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- OSAHS
- What is being tested?
- MRA
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2010to Dec 2011
- Phase
- Observational
- 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
Study population: OSAHS
Who may be able to join
- clinical diagnosis of sleep-disordered breathing
- started treatment with oral appliances, such as mandibular repositioning appliances
Who cannot join
- dental exclusion criteria for MRA
- medical contra-indications for MRA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Self-Reported vs Objective Measured Compliance With Oral Appliance Therapy for Obstructive Sleep Apnea Hypopnea Syndrome
Oral appliances, such as Mandibular Repositioning Appliances (MRA), have emerged as a treatment option for sleep-disordered breathing (SDB).
The purpose of this study is to compare active measurement of MRA compliance with patient's self-report.
Read the detailed description
Background Oral appliances, such as Mandibular Repositioning Appliances (MRA), have emerged as a conservative treatment option for sleep-disordered breathing (SDB).
Up to this date, no objective method is available to measure compliance during oral appliance treatment for SDB.
As with CPAP in the early years, the sleep apnea community nowadays has a strong interest in the objective measurement of oral appliance use and adherence. Subjective measures and self-report commonly result in overestimation of compliance.
Methods We will perform a 12-week clinical trial comparing active/objective measurement of compliance with subjective self-reported usage.
We will enroll 50 patients with an established diagnosis of SDB that received treatment with a titratable, duobloc MRA (RespiDent Butterfly® MRA, RespiDent, Nijlen, Belgium).
Active microsensors (TheraMon®,Handelsagentur Gschladt, Hargelsberg, Oostenrijk) are provided by the Handelsagentr Gschladt (Hargelsberg, Oostenrijk) 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.
The microsensors are intercalated into the MRA devices by the dental technician.
Participants receive explanation to the purpose of the study, in the fact that the investigators want to study temperature fluctuations during the night in the oral cavity. As a result, the subjects are unaware that their MRA use and compliance is being measured.
A first follow-up appointment is scheduled after the first 4 weeks. A second and final follow-up visit is scheduled again 12 weeks after the start of the study.
During each follow-up visit patients are asked to fill out a questionnaire containing questions about MRA wear during the last 4 or 8 weeks (mean hours/night, mean nights/week), respectively. The objective measurement of MRA 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 MRA has been worn when the chip records a temperature intraorally.
This study design will provide a 12-week evaluation of all patients (n=50).
Perspective and Hypothesis The removable nature of an oral appliance warrants an objective assessment of the effective use and compliance with overnight MRA treatment for SDB.
We hypothesize that objective compliance might turn out to be significantly lower compared to the subjectively reported compliance.
- Conditions
- OSAHS
- Being tested
- MRA
- Keywords
- MRA, compliance, OSAHS
- Medical subject headings
- Sleep Apnea, Obstructive, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRADevice
daily wear overnight
| Study group | Role | What they receive |
|---|---|---|
| OSAHS | Not described Receives: Device: MRA |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2011 (estimated)
- Study startNov 2010
- Primary completionJul 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OSAHSStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 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
- NCT01284881
- Sponsor's protocol ID
- EC 10/42/284
- Status last verified
- Jan 2012
- First submitted
- 26 Jan 2011
- Last updated
- 2 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Dieltjens 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 26402736Dieltjens M, Braem MJ, Vroegop AVMT, Wouters K, Verbraecken JA, De Backer WA, Van de Heyning PH, Vanderveken OM. Objectively measured vs self-reported compliance during oral appliance therapy for sleep-disordered breathing. Chest. 2013 Nov;144(5):1495-1502. doi: 10.1378/chest.13-0613.
PubMed 23928873
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Reported vs Objective Measured Compliance With Oral Appliance Therapy for Obstructive Sleep Apnea Hypopnea Syndrome
- ClinicalTrials.gov ID
- NCT01284881
- Acronym / sponsor ID
- EC 10/42/284
- Conditions
- OSAHS
- Keywords
- MRA, compliance, OSAHS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 27 Jan 2011 (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.
Oral appliances, such as Mandibular Repositioning Appliances (MRA), have emerged as a treatment option for sleep-disordered breathing (SDB).
The purpose of this study is to compare active measurement of MRA compliance with patient's self-report.
Detailed description
Background Oral appliances, such as Mandibular Repositioning Appliances (MRA), have emerged as a conservative treatment option for sleep-disordered breathing (SDB).
Up to this date, no objective method is available to measure compliance during oral appliance treatment for SDB.
As with CPAP in the early years, the sleep apnea community nowadays has a strong interest in the objective measurement of oral appliance use and adherence. Subjective measures and self-report commonly result in overestimation of compliance.
Methods We will perform a 12-week clinical trial comparing active/objective measurement of compliance with subjective self-reported usage.
We will enroll 50 patients with an established diagnosis of SDB that received treatment with a titratable, duobloc MRA (RespiDent Butterfly® MRA, RespiDent, Nijlen, Belgium).
Active microsensors (TheraMon®,Handelsagentur Gschladt, Hargelsberg, Oostenrijk) are provided by the Handelsagentr Gschladt (Hargelsberg, Oostenrijk) 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.
The microsensors are intercalated into the MRA devices by the dental technician.
Participants receive explanation to the purpose of the study, in the fact that the investigators want to study temperature fluctuations during the night in the oral cavity. As a result, the subjects are unaware that their MRA use and compliance is being measured.
A first follow-up appointment is scheduled after the first 4 weeks. A second and final follow-up visit is scheduled again 12 weeks after the start of the study.
During each follow-up visit patients are asked to fill out a questionnaire containing questions about MRA wear during the last 4 or 8 weeks (mean hours/night, mean nights/week), respectively. The objective measurement of MRA 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 MRA has been worn when the chip records a temperature intraorally.
This study design will provide a 12-week evaluation of all patients (n=50).
Perspective and Hypothesis The removable nature of an oral appliance warrants an objective assessment of the effective use and compliance with overnight MRA treatment for SDB.
We hypothesize that objective compliance might turn out to be significantly lower compared to the subjectively reported compliance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OSAHS | – | Device: MRA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- OSAHS
Key inclusion criteria (2 listed)
- clinical diagnosis of sleep-disordered breathing
- started treatment with oral appliances, such as mandibular repositioning appliances
Key exclusion criteria (2 listed)
- dental exclusion criteria for MRA
- medical contra-indications for MRA
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 |
|---|---|---|
| MRAdaily wear overnight | Device | OSAHS |
Primary outcome
Not reported in the source record.
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 2 Feb 2012.
- 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.
- Derived from this study: PubMed 23928873Dieltjens M, Braem MJ, Vroegop AVMT, Wouters K, Verbraecken JA, De Backer WA, Van de Heyning PH, Vanderveken OM. Objectively measured vs self-reported compliance during oral appliance therapy for sleep-disordered breathing. Chest. 2013 Nov;144(5):1495-1502. doi: 10.1378/chest.13-0613.
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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?
An observational study of OSAHS, 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 2 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 2 Feb 2012. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01284881, which also lists 2 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 2 Feb 2012.