Obstructive Sleep ApneaNCT02217397
Combinations of Oral Appliance and CPAP for Patients With Severe Obstructive Sleep Apnea Untolerate High-pressure CPAP
A study testing OA, CPAP, combination therapy in people with Obstructive Sleep Apnea, run by National Taiwan University Hospital.
Trial summary
Obstructive sleep apnea (OSA) is a situation of repetitive upper airway obstruction during sleep. For patients with severe OSA, continuous positive airway pressure (CPAP) therapy was the standard therapy, especially those with daytime sleepiness and cardiovascular comorbidities. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- OA, CPAP, combination therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Jul 2015
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New diagnosed obstructive sleep apnea patients older than 20 years old
- AHI more than 30/hr with moderate to severe obstructive sleep apnea
- Willing to accept CPAP and OA treatment
Who cannot join
- nasal problems causing CPAP intolerance
- status post uvulopalatopharyngoplasty
- alcohol abuse and dependence
- life expectancy less than 6 months
- severe cardiopulmonary distress.
Trial locations and contacts
No sites are listed yet.
About this study
Obstructive sleep apnea (OSA) is a situation of repetitive upper airway obstruction during sleep. For patients with severe OSA, continuous positive airway pressure (CPAP) therapy was the standard therapy, especially those with daytime sleepiness and cardiovascular comorbidities. Although CPAP is effective in OSA treatment, the poor adherence due to high pressure was often reported. Instead, oral appliance (OA) was the alternative for those who could not tolerance CPAP or mild to moderate OSA. Oral appliance was less effective in compared with CPAP, but OA is more tolerable and acceptable in OSA patients.
Only one observation study addressed the effects of the combinations of OA and CPAP in OSA patients . The pilot study displayed combination therapy of CPAP and OA is effective in OSA patients and could decrease CPAP pressure. However, the study enrolled the patients with CPAP intolerance according to the subjective chief complaint, not the objective CPAP pressure data. In the present study, we studied the effects of combinations of CPAP and OA for patients with severe OSA who could not tolerate CPAP with high-pressure setting.
Read the detailed description
This is a prospective study in a tertiary teaching hospital, National Taiwan University Hospital. Patients are eligible with age ≧ 20 years old, severe OSA [apnea-hyponea index (AHI) >= 30/hr] who could not tolerate CPAP pressure >15 cmH2O, determined by manual titration (first titration) and willing to use OA.
The study designed was found out the patients with severe OSA (AHI >= 30/hr ). With first titration, the investigators excluded the severe OSA patients using CPAP (CPAP pressure < 15 cmH2O) and could tolerate CPAP. Those patients who could not tolerance CPAP high pressure setting started a three-month oral appliance trial. Then, the investigators repeated the full-channel polysomnography (PSG) with second titration on those with residual AHI ≧ 10/hr while patients were on OA. Therefore, those patients treated with combinations of OA and CPAP for three months and then repeated the PSG. The washout period in each therapy was two weeks. The total follow-up period is about 6 months after enrolled.
The investigators collected the demographic data from medical records and PSG data, including age, gender, body mass index (BMI), CPAP titration, AHI, total sleep time, oxygen desaturation, and arousal index…et al.
Our primary end point is the changes in AHI compared with combination therapy, and OA use. The secondary end points are the difference in titrated CPAP pressure, BMI, blood pressure, and daytime sleepiness compared with combination therapy and OA use.
Statistics analysis Data are presented as mean ± standard deviation (SD). Continuous variables were tested by paired Student's t test in group comparisons. Statistical significance was assumed when a null hypothesis could be rejected at p<0.05. The investigators compared the difference between combination therapy, OA, and baseline by ANOVA, repeated measure. Statistical analysis was done using the SPSS 22.0 for Windows.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- OA, CPAP, combination therapy
- Keywords
- Apnea-hyponea Index, CPAP, Obstructive Sleep Apnea, Oral Appliance
- Medical subject headings
- Sleep Apnea, Obstructive, Microcephaly, Primary Autosomal Recessive, 6
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OA, CPAP, combination therapyDevice
| Study group | Role | What they receive |
|---|---|---|
| OA, CPAPm, combination therapy | Experimental | Not described Receives: Device: OA, CPAP, combination therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference of AHI (Apnea Hypopnea Index ) in different treatment (baseline, OA, combination therapy)
The participants will be followed every month over out patient clinic with measures of change with AHI, sleep quality of life with different treatment (baseline, OA, combination treatment group).
The investigators will record the AHI in different treatment group with OA, CPAP or combination therapy and read if AHI decreased after combination therapy use.
Measured: baseline and1, 3, 6 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionJul 2015 (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 National Taiwan 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Hospital, National Taiwan University Hospital
- Investigators
- Peilin Lee, PhD, Study director, Center of Sleep Disorder, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02217397
- Sponsor's protocol ID
- 201402033RINC
- Status last verified
- Aug 2014
- First submitted
- 5 Aug 2014
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combinations of Oral Appliance and CPAP for Patients With Severe Obstructive Sleep Apnea Untolerate High-pressure CPAP
- ClinicalTrials.gov ID
- NCT02217397
- Acronym / sponsor ID
- 201402033RINC
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Apnea-hyponea Index, CPAP, Obstructive Sleep Apnea, Oral Appliance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Jul 2015 (estimated)
- First posted
- 15 Aug 2014 (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 apnea (OSA) is a situation of repetitive upper airway obstruction during sleep. For patients with severe OSA, continuous positive airway pressure (CPAP) therapy was the standard therapy, especially those with daytime sleepiness and cardiovascular comorbidities. Although CPAP is effective in OSA treatment, the poor adherence due to high pressure was often reported. Instead, oral appliance (OA) was the alternative for those who could not tolerance CPAP or mild to moderate OSA. Oral appliance was less effective in compared with CPAP, but OA is more tolerable and acceptable in OSA patients.
Only one observation study addressed the effects of the combinations of OA and CPAP in OSA patients . The pilot study displayed combination therapy of CPAP and OA is effective in OSA patients and could decrease CPAP pressure. However, the study enrolled the patients with CPAP intolerance according to the subjective chief complaint, not the objective CPAP pressure data. In the present study, we studied the effects of combinations of CPAP and OA for patients with severe OSA who could not tolerate CPAP with high-pressure setting.
Detailed description
This is a prospective study in a tertiary teaching hospital, National Taiwan University Hospital. Patients are eligible with age ≧ 20 years old, severe OSA [apnea-hyponea index (AHI) >= 30/hr] who could not tolerate CPAP pressure >15 cmH2O, determined by manual titration (first titration) and willing to use OA.
The study designed was found out the patients with severe OSA (AHI >= 30/hr ). With first titration, the investigators excluded the severe OSA patients using CPAP (CPAP pressure < 15 cmH2O) and could tolerate CPAP. Those patients who could not tolerance CPAP high pressure setting started a three-month oral appliance trial. Then, the investigators repeated the full-channel polysomnography (PSG) with second titration on those with residual AHI ≧ 10/hr while patients were on OA. Therefore, those patients treated with combinations of OA and CPAP for three months and then repeated the PSG. The washout period in each therapy was two weeks. The total follow-up period is about 6 months after enrolled.
The investigators collected the demographic data from medical records and PSG data, including age, gender, body mass index (BMI), CPAP titration, AHI, total sleep time, oxygen desaturation, and arousal index…et al.
Our primary end point is the changes in AHI compared with combination therapy, and OA use. The secondary end points are the difference in titrated CPAP pressure, BMI, blood pressure, and daytime sleepiness compared with combination therapy and OA use.
Statistics analysis Data are presented as mean ± standard deviation (SD). Continuous variables were tested by paired Student's t test in group comparisons. Statistical significance was assumed when a null hypothesis could be rejected at p<0.05. The investigators compared the difference between combination therapy, OA, and baseline by ANOVA, repeated measure. Statistical analysis was done using the SPSS 22.0 for Windows.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OA, CPAPm, combination therapy | Experimental | Device: OA, CPAP, combination therapy |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- New diagnosed obstructive sleep apnea patients older than 20 years old
- AHI more than 30/hr with moderate to severe obstructive sleep apnea
- Willing to accept CPAP and OA treatment
Key exclusion criteria (5 listed)
- nasal problems causing CPAP intolerance
- status post uvulopalatopharyngoplasty
- alcohol abuse and dependence
- life expectancy less than 6 months
- severe cardiopulmonary distress.
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 |
|---|---|---|
| OA, CPAP, combination therapy | Device | OA, CPAPm, combination therapy |
Primary outcome
The difference of AHI (Apnea Hypopnea Index ) in different treatment (baseline, OA, combination therapy)
Time frame: baseline and1, 3, 6 months later
The participants will be followed every month over out patient clinic with measures of change with AHI, sleep quality of life with different treatment (baseline, OA, combination treatment group). The investigators will record the AHI in different treatment group with OA, CPAP or combination therapy and read if AHI decreased after combination therapy use.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
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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.
Peilin Lee, PhD study director
Center of Sleep Disorder, National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing OA, CPAP, combination therapy in people with Obstructive Sleep Apnea, run by National Taiwan University Hospital.
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 5 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 18 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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 Yi-Chun Lai, MD (+886-2-23562755, toto881049@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference of AHI (Apnea Hypopnea Index ) in different treatment (baseline, OA, combination therapy) (time frame: baseline and1, 3, 6 months later). 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 18 Mar 2015.