Combinations of Oral Appliance and CPAP for Patients With Severe Obstructive Sleep Apnea Untolerate High-pressure CPAP
1 other identifier
interventional
60
0 countries
N/A
Brief 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. 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.
Trial Health
Trial Health Score
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participants targeted
Target at P25-P50 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 5, 2014
CompletedFirst Posted
Study publicly available on registry
August 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedMarch 18, 2015
August 1, 2014
11 months
August 5, 2014
March 16, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
baseline and1, 3, 6 months later
Study Arms (1)
OA, CPAPm, combination therapy
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- nasal problems causing CPAP intolerance
- status post uvulopalatopharyngoplasty
- alcohol abuse and dependence
- life expectancy less than 6 months
- severe cardiopulmonary distress.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Peilin Lee, PhD
Center of Sleep Disorder, National Taiwan University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Seep cencer, National Taiwan University Hospital
Study Record Dates
First Submitted
August 5, 2014
First Posted
August 15, 2014
Study Start
August 1, 2014
Primary Completion
July 1, 2015
Last Updated
March 18, 2015
Record last verified: 2014-08