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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Toru Oga, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier:
NCT00873977
First received: April 1, 2009
Last updated: November 30, 2011
Last verified: November 2011
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • subjective, objective satisfaction and complaints for CPAP therapy [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • respiratory events (ie. apnea-hypopnea index) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • change of positive airway pressure [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • quality of life etc. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Kyoto University, Graduate School of Medicine

Additional 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
Study First Received: April 1, 2009
Last Updated: November 30, 2011
Health Authority: Japan: Institutional Review Board

Keywords provided by 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 Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on October 19, 2014