NCT01096433

Brief Summary

The purpose of this study is to evaluate the associations of circadian variations, sleep architecture, hypertension and prostanoids in the patients with sleep apnea. In addition, the patients introduced to continuous positive airway pressure(CPAP) treatment, the effects of CPAP are also evaluated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 31, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

January 26, 2012

Status Verified

January 1, 2012

Enrollment Period

1.4 years

First QC Date

March 29, 2010

Last Update Submit

January 24, 2012

Conditions

Sleep ApneaContinuous Positive Airway PressureProstaglandinsCircadian Variations

Keywords

Sleep apneaCPAPProstaglandinsCircadian variations

Outcome Measures

Primary Outcomes (1)

  • Prostaglandins in the urine and blood

    baseline, and 2days, 3 months after CPAP

Secondary Outcomes (5)

  • polysomnography measurements

    baseline, and 2days, 3 months after CPAP

  • sleepiness and health-related quality of life

    baseline, and 2days, 3 months after CPAP

  • Clinical measurements (blood pressure, heart rate, sympathetic activity etc)

    baseline, and 2days, 3 months after CPAP

  • serum and urinary biomarker (inflammation, oxidative stress etc.)

    baseline, and 2days, 3 months after CPAP

  • endothelial function

    baseline, and 2days, 3 months after CPAP

Study Arms (1)

CPAP

EXPERIMENTAL

The subjects introduced with CPAP treatment

Device: CPAP treatment

Interventions

CPAP treatmentDEVICE

maintains upper airway patency and minimizes the obstructive events

Also known as: REMstar (Respironics), Auto Set(Resmed), Goodnight (Tyco Healthcare)
CPAP

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Subjects treating for acute infections or malignancy.
  • Subjects with severe cardiovascular disease, diabetes,and renal failure.
  • Subjects taking nonsteroidal anti-inflammatory drugs, steroids or immunosuppressants.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyoto University Graduate School of Medicine

Kyoto, Kyoto, Japan

Location

Related Publications (1)

  • Chihara Y, Chin K, Aritake K, Harada Y, Toyama Y, Murase K, Yoshimura C, Hitomi T, Oga T, Mishima M, Urade Y. A urine biomarker for severe obstructive sleep apnoea patients: lipocalin-type prostaglandin D synthase. Eur Respir J. 2013 Dec;42(6):1563-74. doi: 10.1183/09031936.00133512. Epub 2012 Dec 6.

    PMID: 23222881DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Kazuo Chin, MD,PhD

    Kyoto University, Graduate School of Medicine

    PRINCIPAL INVESTIGATOR

  • Yuichi Chihara, MD

    Kyoto University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor

Study Record Dates

First Submitted

March 29, 2010

First Posted

March 31, 2010

Study Start

May 1, 2010

Primary Completion

October 1, 2011

Study Completion

January 1, 2012

Last Updated

January 26, 2012

Record last verified: 2012-01

Locations

JP(1)