- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00873977
Treatment Adherence and Outcomes in Three Modalities of Continuous Positive Airway Pressure Treatment for Obstructive Sleep Apnea
Comparison of Three Modalities of Continuous Positive Pressure Airway Treatment for Obstructive Sleep Apnea Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Obstructive sleep apnea (OSA) is a common disorder that is associated with substantial morbidity, including excessive daytime sleepiness, hypertension, and cardiovascular disease. Although Continuous Pressure Airway Pressure (CPAP) is effective treatment of objective and subjective complaints, adherence to CPAP therapy is suboptimal. Recently, pressure-relief CPAP (C-flex,A-flex; Respironics; Murrysville, PA) is available. The present study is single-blind,prospective, randomised, crossover study to compare the adherence and effects of therapy with C-flex, A-flex, and autoadjusting CPAP after 3 months of CPAP treatment.
Additionally, after 3 months of CPAP treatment, the patients who treated with C-flex and A-flex will crossovered, we will acess to change of adherence and effects of CPAP treatment.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kyoto, Japan, 6068507
- Kyoto University Graduate School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects on admission for sleep study under the Respiratory Care and Sleep Control Medicine, Kyoto University Hospital.
- Subjects diagnosed with OSA (apnea hypopnea index >=5/hour) by overnight polysomnography.
Exclusion Criteria:
- Subjects diagnosed with CSA by overnight polysomnography.
- Subjects ever used CPAP for OSA.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: C-flex
|
Pressure-relief CPAP treatment may reduce the sensation of breathing against high pressure without causing the upper airways to collapse and improve adherence.
Other Names:
|
Active Comparator: A-flex
|
Pressure-relief CPAP treatment may reduce the sensation of breathing against high pressure without causing the upper airways to collapse and improve adherence.
Other Names:
|
No Intervention: Auto-CPAP
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
objective CPAP adherence (objective adherence are downloaded and reported by the memory card located in the CPAP device.)
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
subjective, objective satisfaction and complaints for CPAP therapy
Time Frame: 3 months
|
3 months
|
respiratory events (ie. apnea-hypopnea index)
Time Frame: 3 months
|
3 months
|
change of positive airway pressure
Time Frame: 3 months
|
3 months
|
quality of life etc.
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Kazuo Chin, MD,PhD, Kyoto University, Graduate School of Medicine
- Principal Investigator: Yuichi Chihara, MD,PhD, Kyoto University, Graduate School of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- C-285
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obstructive Sleep Apnea
-
LivaNovaRecruitingApnea | Obstructive Sleep Apnea | OSA | Apnea, Obstructive | Apnea+Hypopnea | Apnea, Obstructive Sleep | Hypopnea, SleepUnited States
-
Mauro ManconiCompletedObstructive Sleep Apnea Syndrome | Sleep Apnea, Obstructive | Obstructive Sleep Apnea | OSA | Apnea, Obstructive | OSAHSwitzerland
-
University of California, Los AngelesRecruiting
-
Brigham and Women's HospitalCompletedObstructive Sleep Apnea (OSA)United States
-
State Budgetary Healthcare Institution, National...RecruitingObstructive Sleep Apnea | Obstructive Sleep Apnea-hypopnea | Obstructive Sleep Apnea-hypopnea SyndromeRussian Federation
-
The Hospital for Sick ChildrenCompleted
-
Cryosa, Inc.Active, not recruitingObstructive Sleep Apnea of AdultPanama, Paraguay
-
State Key Laboratory of Respiratory DiseaseCompletedObstructive Sleep Apnea of AdultChina
-
Somnics, Inc.UnknownObstructive Sleep Apnea of AdultTaiwan
-
ApnimedCompletedOSA - Obstructive Sleep ApneaUnited States
Clinical Trials on CPAP (REMstar (Respironics))
-
Brigham and Women's HospitalBeth Israel Deaconess Medical Center; National Institutes of Health (NIH); National... and other collaboratorsCompletedObstructive Sleep Apnea | Impaired Glucose Tolerance
-
Kyoto University, Graduate School of MedicineCompletedInflammation | Obstructive Sleep Apnea | Continuous Positive Airway PressureJapan
-
University of CalgaryCompletedSleep Apnea, Obstructive | Renal Insufficiency, Chronic
-
Rutgers, The State University of New JerseyNYU Langone HealthCompleted
-
University of Sao PauloFundação de Amparo à Pesquisa do Estado de São Paulo; Conselho Nacional de...TerminatedObstructive Sleep ApneaBrazil
-
Pavol Jozef Safarik UniversityCompletedMetabolic Syndrome | Obstructive Sleep ApneaSlovakia
-
Queen's UniversityUnknownDepression | Sleep Apnea, ObstructiveCanada
-
Kyoto University, Graduate School of MedicineCompletedObstructive Sleep ApneaJapan
-
Kyoto UniversityCompletedSleep Apnea | Continuous Positive Airway Pressure | Prostaglandins | Circadian VariationsJapan
-
Centre Hospitalier Universitaire de Saint EtienneAssociation Lyonnaise de Logistique PosthospitalièreTerminatedAlzheimer Disease | Early Onset Alzheimer Disease | Obstructive Sleep Apnea SyndromesFrance