MedDataX Logo

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

NCT ID: NCT00873977

Last Updated: 2011-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obstructive Sleep Apnea

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Adherence Continuous Positive Airway Pressure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

C-flex

Group Type ACTIVE_COMPARATOR

CPAP (REMstar (Respironics))

Intervention Type DEVICE

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

A-flex

Group Type ACTIVE_COMPARATOR

CPAP (REMstar (Respironics))

Intervention Type DEVICE

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

Auto-CPAP

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

REMstar (Respironics)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kyoto University, Graduate School of Medicine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Toru Oga

Medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kazuo Chin, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Kyoto University, Graduate School of Medicine

Yuichi Chihara, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Kyoto University, Graduate School of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kyoto University Graduate School of Medicine

Kyoto, Kyoto, Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 23372270 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

C-285

Identifier Type: -

Identifier Source: org_study_id