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

Primary Purpose

Obstructive Sleep Apnea

Status

Completed

Phase

Not Applicable

Locations

Japan

Study Type

Interventional

Intervention

CPAP (REMstar (Respironics))

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Adherence, Continuous Positive Airway Pressure

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Kyoto University Graduate School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Arm Label

C-flex

A-flex

Auto-CPAP

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

subjective, objective satisfaction and complaints for CPAP therapy

respiratory events (ie. apnea-hypopnea index)

change of positive airway pressure

quality of life etc.

Full Information

NCT ID

NCT00873977

First Posted

April 1, 2009

Last Updated

November 30, 2011

Sponsor

Kyoto University, Graduate School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT00873977

Brief Title

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

2. Study Status

Record Verification Date

November 2011

Overall Recruitment Status

Completed

Study Start Date

April 2009 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kyoto University, Graduate School of Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea

Keywords

Adherence, Continuous Positive Airway Pressure

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

93 (Actual)

8. Arms, Groups, and Interventions

Arm Title

C-flex

Arm Type

Active Comparator

Arm Title

A-flex

Arm Type

Active Comparator

Arm Title

Auto-CPAP

Arm Type

No Intervention

Intervention Type

Device

Intervention Name(s)

CPAP (REMstar (Respironics))

Other Intervention Name(s)

REMstar (Respironics)

Intervention Description

Pressure-relief CPAP treatment may reduce the sensation of breathing against high pressure without causing the upper airways to collapse and improve adherence.

Primary Outcome Measure Information:

Title

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

Time Frame

3 months

Secondary Outcome Measure Information:

Title

subjective, objective satisfaction and complaints for CPAP therapy

Time Frame

3 months

Title

respiratory events (ie. apnea-hypopnea index)

Time Frame

3 months

Title

change of positive airway pressure

Time Frame

3 months

Title

quality of life etc.

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kazuo Chin, MD,PhD

Organizational Affiliation

Kyoto University, Graduate School of Medicine

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Yuichi Chihara, MD,PhD

Organizational Affiliation

Kyoto University, Graduate School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kyoto University Graduate School of Medicine

City

Kyoto

ZIP/Postal Code

6068507

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

23372270

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.

Results Reference

derived

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

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