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

November 30, 2011 updated by: Toru Oga, Kyoto University, Graduate School of Medicine

Comparison of Three Modalities of Continuous Positive Pressure Airway Treatment for Obstructive Sleep Apnea Syndrome

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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

93

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kyoto, Japan, 6068507
        • Kyoto University Graduate School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Device: CPAP (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.
Other Names:
  • REMstar (Respironics)
Active Comparator: A-flex
Device: CPAP (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.
Other Names:
  • REMstar (Respironics)
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

This is where you will find people and organizations involved with this study.

Sponsor

Kyoto University, Graduate School of Medicine

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

April 1, 2009

First Submitted That Met QC Criteria

April 1, 2009

First Posted (Estimate)

April 2, 2009

Study Record Updates

Last Update Posted (Estimate)

December 1, 2011

Last Update Submitted That Met QC Criteria

November 30, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

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.

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