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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00873977

Enrollment

Registered

2009-04-02

Start date

2009-04-30

Completion date

2011-07-31

Last updated

2011-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

Adherence, Continuous Positive Airway Pressure

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.

Interventions

DEVICECPAP (REMstar (Respironics))

Pressure-relief CPAP treatment may reduce the sensation of breathing against high pressure without causing the upper airways to collapse and improve adherence.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026