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
1 other identifier
interventional
93
1 country
1
Brief Summary
The purpose of this study is to compare the treatment adherence and effects in three modalities of Continuous Positive Airway Pressure Treatment for Obstructive Sleep Apnea.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2009
Typical duration for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
April 1, 2009
CompletedStudy Start
First participant enrolled
April 1, 2009
CompletedFirst Posted
Study publicly available on registry
April 2, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedDecember 1, 2011
November 1, 2011
2 years
April 1, 2009
November 30, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
objective CPAP adherence (objective adherence are downloaded and reported by the memory card located in the CPAP device.)
3 months
Secondary Outcomes (4)
subjective, objective satisfaction and complaints for CPAP therapy
3 months
respiratory events (ie. apnea-hypopnea index)
3 months
change of positive airway pressure
3 months
quality of life etc.
3 months
Study Arms (3)
C-flex
ACTIVE COMPARATORA-flex
ACTIVE COMPARATORAuto-CPAP
NO INTERVENTIONInterventions
Pressure-relief CPAP treatment may reduce the sensation of breathing against high pressure without causing the upper airways to collapse and improve adherence.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Subjects diagnosed with CSA by overnight polysomnography.
- Subjects ever used CPAP for OSA.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kyoto University Graduate School of Medicine
Kyoto, Kyoto, 6068507, Japan
Related Publications (1)
Chihara Y, Tsuboi T, Hitomi T, Azuma M, Murase K, Toyama Y, Harada Y, Aihara K, Tanizawa K, Handa T, Yoshimura C, Oga T, Yamamoto K, Mishima M, Chin K. Flexible positive airway pressure improves treatment adherence compared with auto-adjusting PAP. Sleep. 2013 Feb 1;36(2):229-36. doi: 10.5665/sleep.2378.
PMID: 23372270DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kazuo Chin, MD,PhD
Kyoto University, Graduate School of Medicine
- PRINCIPAL INVESTIGATOR
Yuichi Chihara, MD,PhD
Kyoto University, Graduate School of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical doctor
Study Record Dates
First Submitted
April 1, 2009
First Posted
April 2, 2009
Study Start
April 1, 2009
Primary Completion
April 1, 2011
Study Completion
July 1, 2011
Last Updated
December 1, 2011
Record last verified: 2011-11