OSAThaiSomnoguardNCT01466309
Efficacy of Adjustable Thermoplastic Oral Appliances in Patient With OSA
A study testing Somnoguard oral appliances in people with OSA and Complication, run by Mahidol University at 1 site in Thailand.
Trial summary
Somnoguard, a titratable-thermoplastic oral appliances for the treatment of OSA, has been reported its safety and efficacy in Caucasians at least in the short-term. However, there has been no reports in Thai patients. The objectives of this study is to investigate its efficacy and safety in Thai patients with OSA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- OSA, Complication
- What is being tested?
- Somnoguard oral appliances
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteThailand
- Study dates
- Jul 2011to Dec 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
- Age > 18 years with OSA
- AHI > 5
- Refused CPAP therapy
Who cannot join
- Poor oral hygiene
- Untreated TMD
- Inadequate healthy teeth (< 6)
- Severe or unstable medical problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Adjustable Thermoplastic Oral Appliances in Thai Patient With OSA
Somnoguard, a titratable-thermoplastic oral appliances for the treatment of OSA, has been reported its safety and efficacy in Caucasians at least in the short-term. However, there has been no reports in Thai patients. The objectives of this study is to investigate its efficacy and safety in Thai patients with OSA.
Read the detailed description
Fifty patients with any severity of OSA will be recruited according to the indications for oral appliance therapy in the practice parameters of the American Academy of Sleep Medicine (AASM)2006.
- Conditions
- OSA, Complication
- Being tested
- Somnoguard oral appliances
- Keywords
- AHI, ESS, VAS, FOSQ, SF-36
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Somnoguard oral appliancesDevice
wearing somnogaurd daily at bedtime
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | patients treated with Somnoguard Receives: Device: Somnoguard oral appliances |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-Hypopnea index
Measured: 1 year
Secondary outcomes (1)
Number of Participants with Adverse Events"
Number of Participants with Adverse Events"
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 posted7 Nov 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OSAStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- wish banhiran, MD, Principal investigator, Yes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01466309
- Sponsor's protocol ID
- Somnoguard in Thai OSA
- Acronym
- ThaiSomnoguard
- Status last verified
- Nov 2011
- First submitted
- 1 Nov 2011
- Last updated
- 7 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Adjustable Thermoplastic Oral Appliances in Thai Patient With OSA
- ClinicalTrials.gov ID
- NCT01466309
- Acronym / sponsor ID
- ThaiSomnoguard / Somnoguard in Thai OSA
- Conditions
- OSA, Complication
- Keywords
- AHI, ESS, VAS, FOSQ, SF-36
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 7 Nov 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.
Somnoguard, a titratable-thermoplastic oral appliances for the treatment of OSA, has been reported its safety and efficacy in Caucasians at least in the short-term. However, there has been no reports in Thai patients. The objectives of this study is to investigate its efficacy and safety in Thai patients with OSA.
Detailed description
Fifty patients with any severity of OSA will be recruited according to the indications for oral appliance therapy in the practice parameters of the American Academy of Sleep Medicine (AASM)2006.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Device: Somnoguard oral appliancespatients treated with Somnoguard |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years with OSA
- AHI > 5
- Refused CPAP therapy
Key exclusion criteria (4 listed)
- Poor oral hygiene
- Untreated TMD
- Inadequate healthy teeth (< 6)
- Severe or unstable medical problems.
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 |
|---|---|---|
| Somnoguard oral applianceswearing somnogaurd daily at bedtime | Device | treatment |
Primary outcome
Apnea-Hypopnea index
Time frame: 1 year
1 secondary outcome
Number of Participants with Adverse Events"
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2011.
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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.
wish banhiran, MD principal investigator
Yes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Somnoguard oral appliances in people with OSA and Complication, run by Mahidol University at 1 site in Thailand.
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 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: status not confirmed, as of the sponsor's last update on 7 Nov 2011. 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 Thailand. 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?
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?
Apnea-Hypopnea index (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 7 Nov 2011.