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Completed

NCT Number: NCT00873977

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

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kyoto University Graduate School of Medicine

Kyoto, 6068507, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CPAP (REMstar (Respironics))

Device

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)

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

Sponsors and collaborators

Lead sponsor

Kyoto University, Graduate School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 2, 2009
Registry last updated
Dec 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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