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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00873977
• Other study ID #: C-285
• Status: Completed
• Phase: N/A
• First received: April 1, 2009
• Last updated: November 30, 2011
• Start date: April 2009
• Est. completion date: July 2011

Study information

• Verified date: November 2011
• Source: Kyoto University, Graduate School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: July 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
Japan	Kyoto University Graduate School of Medicine	Kyoto

Sponsors (1)

Lead Sponsor	Collaborator
Kyoto University, Graduate School of Medicine

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objective CPAP adherence (objective adherence are downloaded and reported by the memory card located in the CPAP device.)		3 months	No
Secondary	subjective, objective satisfaction and complaints for CPAP therapy		3 months	No
Secondary	respiratory events (ie. apnea-hypopnea index)		3 months	No
Secondary	change of positive airway pressure		3 months	No
Secondary	quality of life etc.		3 months	No