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

K

Kyoto University, Graduate School of Medicine

Status

Completed

Conditions

Obstructive Sleep Apnea

Treatments

Device: CPAP (REMstar (Respironics))

Study type

Interventional

Funder types

Other

Identifiers

NCT00873977
C-285

Details and patient eligibility

About

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.

Full 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.

Enrollment

93 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

93 participants in 3 patient groups

C-flex
Active Comparator group
Treatment:
Device: CPAP (REMstar (Respironics))
A-flex
Active Comparator group
Treatment:
Device: CPAP (REMstar (Respironics))
Auto-CPAP
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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