Obstructive Sleep ApneaNCT01209468
Treatment of Sleep Apnea With Oral Appliances
A study testing monobloc oral appliance and twinblock oral appliance in people with Obstructive Sleep Apnea, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Obstructive sleep apnoea (OSA) is a serious and common disorder affecting one in twenty-five men and one in fifty women over the age of 30. This breathing abnormality occurs during sleep and is characterised by snoring and episodes of sleep disturbances. The symptoms of untreated OSA (e.g. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- monobloc oral appliance and twinblock oral appliance
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteHong Kong
- Study dates
- Jun 2008to Dec 2010
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 or older
- AHI ≥ 10-30/h, and those who do not tolerate CPAP or refused CPAP if AHI >30
- A score of > 10 on the Epworth Sleepiness Scale
- Body Mass Index <35kg/m
- Those who are competent to give written informed consent
- have adequate dental anchoring structures (<10 periodontally healthy teeth per arch)
Who cannot join
- Previous surgery to upper respiratory airway
- Concurrent unstable cardiovascular disease, neurological, mental or psychiatric disorders
- Recent major surgery in the last 6 months
- Pregnancy
- Epilepsy
- temporomandibular joint (TMJ) disfunction (pain during mandibular advancement or limitation of mouth opening)
- untreated dental decay
Trial locations and contacts
1 site in 1 country.
Anika Ahrens, MA contact
Hong Kong1 site, 1 recruiting
- Recruiting
Prince Philip Dental Hospital
Hong Kong
Colman McGrath, Professor
About this study
Official title: A Randomized Clinical Trial of the Treatment of Obstructive Sleep Apnoea Using Oral Appliances
Obstructive sleep apnoea (OSA) is a serious and common disorder affecting one in twenty-five men and one in fifty women over the age of 30. This breathing abnormality occurs during sleep and is characterised by snoring and episodes of sleep disturbances. The symptoms of untreated OSA (e.g. excessive daytime sleepiness), can result in significant reductions in the patients' quality of life. The key treatment modalities today include Continuous Positive Air Pressure (CPAP), surgery and the use of oral appliances (OAs). Increasingly, OAs have been advocated in the treatment of the symptoms of OSA since they offer a non-invasive form of treatment and also because patients often prefer this treatment to other treatment modalities. There is increasing evidence to support the effectiveness of OAs in the management of OSA, at least as a short term measure. What is still unclear is which types of OA are most effective and whether OAs are effective in the long term management of OSA. This randomized clinical trial aims to evaluate two differently designed OAs in terms of their effect on patients' quality of life and on the physiological symptoms of OSA (apnoea/hypopnoea index AHI). Around 45 patients with OSA will be recruited from a pool of patients referred to the dental hospital for treatment from the medical faculty. The treatment with OAs will commence after randomization to two treatment groups; follow-up examinations will take place over a period of 12 months. The results of this study will help inform practitioners and patients of the feasibility of using OAs in the long term management of OSA and help determine the most appropriate type of OAs for the management of OSA and improvement in quality of life.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- monobloc oral appliance, twinblock oral appliance
- 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.
monobloc oral applianceDevice
one piece oral appliance
twinblock oral applianceDevice
two-piece oral appliance
| Study group | Role | What they receive |
|---|---|---|
| oral appliance 2 | Active comparator | Patients in treatment arm/group B will have a customized twinblock OA constructed for them individually. They will undergo an appliance acclimatization period of 4-5 weeks. Three months after baseline assessments - T1 (6 weeks of 'active' treatment), physiological measurements will be evaluated, clinical oral examinations conducted, quality of life and compliance assessed. Following this, a customized monobloc OA will be constructed for subjects individually and they will acclimatize to it for 4-5 weeks (so that the mandible is protruded to the maximum position they feel comfortable with when the appliance is worn). Prior to the active treatment phase, patients will not wear the monobloc OA for 1 week (washout phase). Three months later - T2 (6 weeks of 'active' treatment), all the previous measurements will be conducted again. Receives: Device: twinblock oral appliance |
| oral appliance 1 | Experimental | Patients in treatment arm/group A will have a customized monobloc OA constructed for them individually. They will undergo an appliance acclimatization period of 4-5 weeks. Three months after baseline assessments - T1 (6 weeks of 'active' treatment), physiological measurements will be evaluated, clinical oral examinations conducted, quality of life and compliance assessed. Following this, a customized twin-bloc OA will be constructed for subjects individually and they will acclimatize to it for 4-5 weeks (so that the mandible is protruded to the maximum position they feel comfortable with when the appliance is worn). Prior to the active treatment phase, patients will not wear the twin-bloc OA for 1 week (washout phase). Three months later - T2 (6 weeks of 'active' treatment), all the previous measurements will be conducted again. Receives: Device: monobloc oral appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Quality of life scores collected by the Sleep Apnoea Quality of Life Index questionnaire.
The minimum important clinical difference (MICD) for this index is a change in score of 1. A mean change of at least 1 in the SAQLI scores (SD=1.1) between the two groups (treated two types of oral appliances) is expected.
Measured: 6 months
Secondary outcomes (1)
objective OSA markers
Physiological variables measured during polysomnography, such as apnea-hypopnea index (AHI).
Complete response: Resolution of symptoms and improvement of objective variables Partial response: more than 50% reduction in AHI but AHI's remaining above 5/h Failure: ongoing clinincal symptoms and/or less than 50% reduction in AHI
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2010 (estimated)
- Study startJun 2008
- Primary completionNov 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Colman McGrath, Professor, Principal investigator, Faculty of Dentistry, HKU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01209468
- Sponsor's protocol ID
- 1
- Status last verified
- Sep 2010
- First submitted
- 24 Sep 2010
- Last updated
- 27 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of the Treatment of Obstructive Sleep Apnoea Using Oral Appliances
- ClinicalTrials.gov ID
- NCT01209468
- Acronym / sponsor ID
- 1
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 27 Sep 2010 (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.
Obstructive sleep apnoea (OSA) is a serious and common disorder affecting one in twenty-five men and one in fifty women over the age of 30. This breathing abnormality occurs during sleep and is characterised by snoring and episodes of sleep disturbances. The symptoms of untreated OSA (e.g. excessive daytime sleepiness), can result in significant reductions in the patients' quality of life. The key treatment modalities today include Continuous Positive Air Pressure (CPAP), surgery and the use of oral appliances (OAs). Increasingly, OAs have been advocated in the treatment of the symptoms of OSA since they offer a non-invasive form of treatment and also because patients often prefer this treatment to other treatment modalities. There is increasing evidence to support the effectiveness of OAs in the management of OSA, at least as a short term measure. What is still unclear is which types of OA are most effective and whether OAs are effective in the long term management of OSA. This randomized clinical trial aims to evaluate two differently designed OAs in terms of their effect on patients' quality of life and on the physiological symptoms of OSA (apnoea/hypopnoea index AHI). Around 45 patients with OSA will be recruited from a pool of patients referred to the dental hospital for treatment from the medical faculty. The treatment with OAs will commence after randomization to two treatment groups; follow-up examinations will take place over a period of 12 months. The results of this study will help inform practitioners and patients of the feasibility of using OAs in the long term management of OSA and help determine the most appropriate type of OAs for the management of OSA and improvement in quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral appliance 2 | Active comparator | Device: twinblock oral appliancePatients in treatment arm/group B will have a customized twinblock OA constructed for them individually. They will undergo an appliance acclimatization period of 4-5 weeks. Three months after baseline assessments - T1 (6 weeks of 'active' treatment), physiological measurements will be evaluated, clinical oral examinations conducted, quality of life and compliance assessed. Following this, a customized monobloc OA will be constructed for subjects individually and they will acclimatize to it for 4-5 weeks (so that the mandible is protruded to the maximum position they feel comfortable with when the appliance is worn). Prior to the active treatment phase, patients will not wear the monobloc OA for 1 week (washout phase). Three months later - T2 (6 weeks of 'active' treatment), all the previous measurements will be conducted again. |
| oral appliance 1 | Experimental | Device: monobloc oral appliancePatients in treatment arm/group A will have a customized monobloc OA constructed for them individually. They will undergo an appliance acclimatization period of 4-5 weeks. Three months after baseline assessments - T1 (6 weeks of 'active' treatment), physiological measurements will be evaluated, clinical oral examinations conducted, quality of life and compliance assessed. Following this, a customized twin-bloc OA will be constructed for subjects individually and they will acclimatize to it for 4-5 weeks (so that the mandible is protruded to the maximum position they feel comfortable with when the appliance is worn). Prior to the active treatment phase, patients will not wear the twin-bloc OA for 1 week (washout phase). Three months later - T2 (6 weeks of 'active' treatment), all the previous measurements will be conducted again. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 or older
- AHI ≥ 10-30/h, and those who do not tolerate CPAP or refused CPAP if AHI >30
- A score of > 10 on the Epworth Sleepiness Scale
- Body Mass Index <35kg/m
- Those who are competent to give written informed consent
Key exclusion criteria (7 listed)
- Previous surgery to upper respiratory airway
- Concurrent unstable cardiovascular disease, neurological, mental or psychiatric disorders
- Recent major surgery in the last 6 months
- Pregnancy
- Epilepsy
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 |
|---|---|---|
| monobloc oral applianceone piece oral appliance | Device | oral appliance 1 |
| twinblock oral appliancetwo-piece oral appliance | Device | oral appliance 2 |
Primary outcome
Quality of life
Time frame: 6 months
Quality of life scores collected by the Sleep Apnoea Quality of Life Index questionnaire. The minimum important clinical difference (MICD) for this index is a change in score of 1. A mean change of at least 1 in the SAQLI scores (SD=1.1) between the two groups (treated two types of oral appliances) is expected.
1 secondary outcome
objective OSA markers
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2010.
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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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.
Anika Ahrens, MA contact
Colman McGrath, Professor principal investigator
Faculty of Dentistry, HKU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing monobloc oral appliance and twinblock oral appliance in people with Obstructive Sleep Apnea, run by The University of Hong Kong at 1 site in Hong Kong.
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 6 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: status not confirmed, as of the sponsor's last update on 27 Sep 2010. 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 Hong Kong. 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?
Contact Colman McGrath, Professor (+852 28590513, mcgrathc@hkucc.hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: 6 months). 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 27 Sep 2010.