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CompletedNCT00873977Updated Dec 1, 2011

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

An interventional study of CPAP (REMstar (Respironics)) in Obstructive Sleep Apnea, sponsored by Kyoto University, Graduate School of Medicine. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2011-12-01.

Sponsored by Kyoto University, Graduate School of Medicine · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
93
Allocation
Randomized
Ages
20 Years and older
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Obstructive Sleep Apnea

Keywords

  • Adherence
  • Continuous Positive Airway Pressure
03

In context

Apnea

1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.

This study's enrollment of 93 is above the median of 50 across 965 interventional studies indexed under Apnea.

Browse Apnea studies →

Lead sponsor

Kyoto University, Graduate School of Medicine is the lead sponsor of 21 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Subjects diagnosed with CSA by overnight polysomnography.
  • Subjects ever used CPAP for OSA.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
93 participants (actual)

Study arms

  • Active comparator
    C-flex

    Device: CPAP (REMstar (Respironics))

  • Active comparator
    A-flex

    Device: CPAP (REMstar (Respironics))

  • No intervention
    Auto-CPAP

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.

    Also known as: REMstar (Respironics)

06

What researchers measure

Primary outcomes

  1. objective CPAP adherence (objective adherence are downloaded and reported by the memory card located in the CPAP device.)

    Time frame: 3 months

Secondary outcomes

  1. subjective, objective satisfaction and complaints for CPAP therapy

    Time frame: 3 months

  2. respiratory events (ie. apnea-hypopnea index)

    Time frame: 3 months

  3. change of positive airway pressure

    Time frame: 3 months

  4. quality of life etc.

    Time frame: 3 months

07

Study locations

1 site
  • Kyoto University Graduate School of Medicine
    Kyoto, 6068507, Japan
08

References and documents

Publications

  • Chihara Y, Tsuboi T, Hitomi T, Azuma M, Murase K, Toyama Y, Harada Y, Aihara K, Tanizawa K, Handa T, Yoshimura C, Oga T, Yamamoto K, Mishima M, Chin K. Flexible positive airway pressure improves treatment adherence compared with auto-adjusting PAP. Sleep. 2013 Feb 1;36(2):229-36. doi: 10.5665/sleep.2378. PubMed 23372270 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 1, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00873977
Lead sponsor
Kyoto University, Graduate School of Medicine
Responsible party
Toru Oga (Medical doctor, Kyoto University, Graduate School of Medicine) — Principal investigator
First posted
Apr 2, 2009
Start date
Apr 2009
Primary completion
Apr 2011
Completion
Jul 2011
Last update
Dec 1, 2011

Study contacts

Kazuo Chin, MD,PhD
principal investigator · Kyoto University, Graduate School of Medicine
Yuichi Chihara, MD,PhD
principal investigator · Kyoto University, Graduate School of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.

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