Clinical trial NCT00873977: Treatment Adherence and Outcomes in Three Modalities of Continuous Positive Airway Pressure Treatment for Obstructive Sleep Apnea
Official title: Comparison of Three Modalities of Continuous Positive Pressure Airway Treatment for Obstructive Sleep Apnea Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Adherence
Continuous Positive Airway Pressure
Lead sponsor: Kyoto University, Graduate School of Medicine
Sponsor class: OTHER
First posted: 2009-04-02
Enrollment: 93
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: objective CPAP adherence (objective adherence are downloaded and reported by the memory card located in the CPAP device.)
timeFrame: 3 months
Secondary outcomes:
measure: subjective, objective satisfaction and complaints for CPAP therapy
timeFrame: 3 months
measure: respiratory events (ie. apnea-hypopnea index)
timeFrame: 3 months
measure: change of positive airway pressure
timeFrame: 3 months
measure: quality of life etc.
timeFrame: 3 months
Other outcomes:
Locations:
city: Kyoto
country: Japan
facility: Kyoto University Graduate School of Medicine
Study officials:
affiliation: Kyoto University, Graduate School of Medicine
name: Kazuo Chin, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyoto University, Graduate School of Medicine
name: Yuichi Chihara, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.