Treatment Adherence and Outcomes in Three Modalities of Continuous Positive Airway Pressure Treatment for Obstructive Sleep Apnea

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: CPAP (REMstar (Respironics))

• Registration Number: NCT00873977
• Lead Sponsor: Kyoto University, Graduate School of Medicine

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.

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 Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-01
• Study First Submitted QC: 2009-04-01
• Study First Posted: 2009-04-02
• Primary Completion: 2011-04
• Study Completion: 2011-07
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-30
• Last Update Posted: 2011-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
C-flex	CPAP (REMstar (Respironics))	-
A-flex	CPAP (REMstar (Respironics))	-

Primary Outcome Measures

Name	Time	Method
objective CPAP adherence (objective adherence are downloaded and reported by the memory card located in the CPAP device.)	3 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Kyoto University Graduate School of Medicine; 🇯🇵 Kyoto, Japan