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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00873977
First Posted: April 2, 2009
Last Update Posted: December 1, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Toru Oga, Kyoto University, Graduate School of Medicine
  Purpose
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.

Condition Intervention
Obstructive Sleep Apnea Device: CPAP (REMstar (Respironics))

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of Three Modalities of Continuous Positive Pressure Airway Treatment for Obstructive Sleep Apnea Syndrome

Resource links provided by NLM:


Further study details as provided by Toru Oga, Kyoto University, Graduate School of Medicine:

Primary Outcome Measures:
  • objective CPAP adherence (objective adherence are downloaded and reported by the memory card located in the CPAP device.) [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • subjective, objective satisfaction and complaints for CPAP therapy [ Time Frame: 3 months ]
  • respiratory events (ie. apnea-hypopnea index) [ Time Frame: 3 months ]
  • change of positive airway pressure [ Time Frame: 3 months ]
  • quality of life etc. [ Time Frame: 3 months ]

Enrollment: 93
Study Start Date: April 2009
Study Completion Date: July 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: REMstar (Respironics)
No Intervention: Auto-CPAP

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00873977


Locations
Japan
Kyoto University Graduate School of Medicine
Kyoto, Japan, 6068507
Sponsors and Collaborators
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Toru Oga, Medical doctor, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier: NCT00873977     History of Changes
Other Study ID Numbers: C-285
First Submitted: April 1, 2009
First Posted: April 2, 2009
Last Update Posted: December 1, 2011
Last Verified: November 2011

Keywords provided by Toru Oga, Kyoto University, Graduate School of Medicine:
Adherence
Continuous Positive Airway Pressure

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases