Obstructive Sleep ApneaNCT02885571
Can Objective Compliance Monitoring Increase Mandibular Advancement Device Usage in Obstructive Sleep Apnea Patients
A study testing SomnoDent Flex with DentiTrac in people with Obstructive Sleep Apnea, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study evaluates whether objective compliance monitoring can increase mandibular advancement device (MAD) usage in obstructive sleep apnea (OSA) patients. Half of participants will be assigned to objective compliance monitoring group (experimental group), while the other will be assigned to subjective compliance… Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- SomnoDent Flex with DentiTrac
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Apr 2016to 3 Jul 2017
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- obstructive sleep apnea patients without a history of soft palate surgery and moderate to severe periodontal disease.
Who cannot join
- central sleep apnea
- active mandibular disease
- tooth grinding
- moderate to severe periodontal disease
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates whether objective compliance monitoring can increase mandibular advancement device (MAD) usage in obstructive sleep apnea (OSA) patients. Half of participants will be assigned to objective compliance monitoring group (experimental group), while the other will be assigned to subjective compliance monitoring group (control group). A physician will prescribe and explain to patients based on data from objective or subjective compliance monitoring.
Read the detailed description
The design of this study is a randomized controlled trial. Total 40 participants are randomly divided into 2 groups: objective compliance monitoring (n=20) and subjective compliance monitoring (n=20). Both groups wear the same MAD (commercial name: SomnoDent Flex with DentiTrac). They visit Seol National University Hospital at 1, 3, and 6 month after the initiation of MAD. A research coordinator acquires data by downloading from the MAD or by asking the patients, and then transfer the information to the physician. If the patient belongs to objective compliance group, data from the MAD will be transferred to the physician. But if the patient belongs to subjective compliance group, data acquired by asking patients will be transferred to the physician. A physician will prescribe and explain to patients based on data from objective or subjective compliance monitoring.The primary aims is to examine the effectiveness of SomnoDent Flex with DentiTrac, in terms of compliance.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- SomnoDent Flex with DentiTrac
- 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.
SomnoDent Flex with DentiTracDevice
| Study group | Role | What they receive |
|---|---|---|
| MAD for subjective compliance | Active comparator | MAD for subjective compliance group wears the same SomnoDent Flex with DentiTrac to objective group, but they are subjected to be prescribed based on the subjective compliance data, which are acquired from patient's explanation. Compliance (average daily time, Receives: Device: SomnoDent Flex with DentiTrac |
| MAD for objective compliance | Experimental | MAD for objective compliance group wears the same SomnoDent Flex with DentiTrac to subjective group, but they are subjected to be prescribed based on the objective compliance data, which are acquired from data recorded within SomnoDent Flex with DentiTrac. Receives: Device: SomnoDent Flex with DentiTrac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average daily use (hours)
The average number of hours the patient wore and did not wear the SomnoDent Flex with DentiTrac for previous one month
Measured: one month
Secondary outcomes (2)
Days used for ≥ 15 min
Days the patient wore for ≥ 15 min the SomnoDent Flex with DentiTrac for previous one month
Measured: one month
Days used for ≥ 4 hrs
Days the patient wore for ≥ 4 hrs the SomnoDent Flex with DentiTrac for previous one month
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study start21 Apr 2016
- Primary completion13 Jun 2017
- Study completion3 Jul 2017
Why it stopped: Due to suggestions of IRB committee in our institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun-Woo Shin, Seoul National University Hospital
- Investigators
- Tae-Bin Won, Dr., Study chair, Department of Otorhinolaryngology, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02885571
- Sponsor's protocol ID
- D-1510-035-709
- Status last verified
- Nov 2017
- First submitted
- 17 Aug 2016
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Phillips CL, Grunstein RR, Darendeliler MA, Mihailidou AS, Srinivasan VK, Yee BJ, Marks GB, Cistulli PA. Health outcomes of continuous positive airway pressure versus oral appliance treatment for obstructive sleep apnea: a randomized controlled trial. Am J Respir Crit Care Med. 2013 Apr 15;187(8):879-87. doi: 10.1164/rccm.201212-2223OC.
PubMed 23413266Kushida CA, Morgenthaler TI, Littner MR, Alessi CA, Bailey D, Coleman J Jr, Friedman L, Hirshkowitz M, Kapen S, Kramer M, Lee-Chiong T, Owens J, Pancer JP; American Academy of Sleep. Practice parameters for the treatment of snoring and Obstructive Sleep Apnea with oral appliances: an update for 2005. Sleep. 2006 Feb;29(2):240-3. doi: 10.1093/sleep/29.2.240.
PubMed 16494092Vanderveken OM, Dieltjens M, Wouters K, De Backer WA, Van de Heyning PH, Braem MJ. Objective measurement of compliance during oral appliance therapy for sleep-disordered breathing. Thorax. 2013 Jan;68(1):91-6. doi: 10.1136/thoraxjnl-2012-201900. Epub 2012 Sep 19.
PubMed 22993169
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Objective Compliance Monitoring Increase Mandibular Advancement Device Usage in Obstructive Sleep Apnea Patients
- ClinicalTrials.gov ID
- NCT02885571
- Acronym / sponsor ID
- D-1510-035-709
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to suggestions of IRB committee in our institution
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 21 Apr 2016 (actual)
- Primary completion
- 13 Jun 2017 (actual)
- Study completion
- 3 Jul 2017 (actual)
- First posted
- 31 Aug 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.
This study evaluates whether objective compliance monitoring can increase mandibular advancement device (MAD) usage in obstructive sleep apnea (OSA) patients. Half of participants will be assigned to objective compliance monitoring group (experimental group), while the other will be assigned to subjective compliance monitoring group (control group). A physician will prescribe and explain to patients based on data from objective or subjective compliance monitoring.
Detailed description
The design of this study is a randomized controlled trial. Total 40 participants are randomly divided into 2 groups: objective compliance monitoring (n=20) and subjective compliance monitoring (n=20). Both groups wear the same MAD (commercial name: SomnoDent Flex with DentiTrac). They visit Seol National University Hospital at 1, 3, and 6 month after the initiation of MAD. A research coordinator acquires data by downloading from the MAD or by asking the patients, and then transfer the information to the physician. If the patient belongs to objective compliance group, data from the MAD will be transferred to the physician. But if the patient belongs to subjective compliance group, data acquired by asking patients will be transferred to the physician. A physician will prescribe and explain to patients based on data from objective or subjective compliance monitoring.The primary aims is to examine the effectiveness of SomnoDent Flex with DentiTrac, in terms of compliance.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MAD for subjective compliance | Active comparator | Device: SomnoDent Flex with DentiTracMAD for subjective compliance group wears the same SomnoDent Flex with DentiTrac to objective group, but they are subjected to be prescribed based on the subjective compliance data, which are acquired from patient's explanation. Compliance (average daily time, |
| MAD for objective compliance | Experimental | Device: SomnoDent Flex with DentiTracMAD for objective compliance group wears the same SomnoDent Flex with DentiTrac to subjective group, but they are subjected to be prescribed based on the objective compliance data, which are acquired from data recorded within SomnoDent Flex with DentiTrac. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- obstructive sleep apnea patients without a history of soft palate surgery and moderate to severe periodontal disease.
Key exclusion criteria (4 listed)
- central sleep apnea
- active mandibular disease
- tooth grinding
- moderate to severe periodontal 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 |
|---|---|---|
| SomnoDent Flex with DentiTrac | Device | MAD for objective compliance, MAD for subjective compliance |
Primary outcome
Average daily use (hours)
Time frame: one month
The average number of hours the patient wore and did not wear the SomnoDent Flex with DentiTrac for previous one month
2 secondary outcomes
Days used for ≥ 15 min
Time frame: one month
Days used for ≥ 4 hrs
Time frame: one month
Results and safety
The study was stopped early (reason given: Due to suggestions of IRB committee in our institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Background: PubMed 23413266Phillips CL, Grunstein RR, Darendeliler MA, Mihailidou AS, Srinivasan VK, Yee BJ, Marks GB, Cistulli PA. Health outcomes of continuous positive airway pressure versus oral appliance treatment for obstructive sleep apnea: a randomized controlled trial. Am J Respir Crit Care Med. 2013 Apr 15;187(8):879-87. doi: 10.1164/rccm.201212-2223OC.
- Background: PubMed 16494092Kushida CA, Morgenthaler TI, Littner MR, Alessi CA, Bailey D, Coleman J Jr, Friedman L, Hirshkowitz M, Kapen S, Kramer M, Lee-Chiong T, Owens J, Pancer JP; American Academy of Sleep. Practice parameters for the treatment of snoring and Obstructive Sleep Apnea with oral appliances: an update for 2005. Sleep. 2006 Feb;29(2):240-3. doi: 10.1093/sleep/29.2.240.
- Background: PubMed 22993169Vanderveken OM, Dieltjens M, Wouters K, De Backer WA, Van de Heyning PH, Braem MJ. Objective measurement of compliance during oral appliance therapy for sleep-disordered breathing. Thorax. 2013 Jan;68(1):91-6. doi: 10.1136/thoraxjnl-2012-201900. Epub 2012 Sep 19.
- Individual participant dataSharing planned: No
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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.
Tae-Bin Won, Dr. study chair
Department of Otorhinolaryngology, Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SomnoDent Flex with DentiTrac in people with Obstructive Sleep Apnea, run by Seoul National University Hospital at 1 site in South Korea.
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 1 inclusion and 4 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 6 Nov 2017. 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 South Korea. 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: Due to suggestions of IRB committee in our institution). 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?
Average daily use (hours) (time frame: one month). 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 NCT02885571, which also lists 3 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 6 Nov 2017.