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CompletedNCT01096433Updated Jan 26, 2012

Circadian Variations of Prostaglandin in Sleep Apnea

An interventional study of CPAP treatment in Sleep Apnea, Continuous Positive Airway Pressure and Prostaglandins, sponsored by Kyoto University. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2012-01-26.

Sponsored by Kyoto University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Non-randomized
Ages
20 Years and older
Sex
All
01

Study 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.

Read the detailed description

Obstructive sleep apnea (OSA) is characterized by repetitive episodes of upper airway obstruction during sleep that provoke frequents arousals, sleep fragmentation, oxygen desaturation, and excessive daytime sleepiness. OSA may contribute to the development of systemic hypertension, cardiovascular disease. Many studies has reported a crucial role for the prostaglandin D system in sleep regulation. In addition, it has been described urinary or blood levels of prostaglandins was higher in the patients with hypertension, diabetes mellitus, and these values were associated with the severity of coronary artery disease. However, the relation between alterations of prostaglandin D system and sleep architecture, sleepiness, and clinical outcomes such as hypertension, arteriosclerosis in the patients with OSA are not known. Additionally, after CPAP treatment, we will investigate the association between change of prostaglandin system and sleep architecture, sleepiness, clinical outcomes.

02

Conditions studied

  • Sleep Apnea
  • Continuous Positive Airway Pressure
  • Prostaglandins
  • Circadian Variations

Keywords

  • Sleep apnea
  • CPAP
  • Prostaglandins
  • Circadian variations
03

In context

Sleep Apnea Syndromes

2,183 studies on the registry are indexed under Sleep Apnea Syndromes; 284 are open to participants now.

This study's enrollment of 64 is above the median of 53 across 1,400 interventional studies indexed under Sleep Apnea Syndromes.

Browse Sleep Apnea Syndromes studies →

Lead sponsor

Kyoto University is the lead sponsor of 22 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    CPAP

    The subjects introduced with CPAP treatment

    Device: CPAP treatment

Interventions

  • DeviceCPAP treatment

    maintains upper airway patency and minimizes the obstructive events

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

06

What researchers measure

Primary outcomes

  1. Prostaglandins in the urine and blood

    Time frame: baseline, and 2days, 3 months after CPAP

Secondary outcomes

  1. polysomnography measurements

    Time frame: baseline, and 2days, 3 months after CPAP

  2. sleepiness and health-related quality of life

    Time frame: baseline, and 2days, 3 months after CPAP

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

    Time frame: baseline, and 2days, 3 months after CPAP

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

    Time frame: baseline, and 2days, 3 months after CPAP

  5. endothelial function

    Time frame: baseline, and 2days, 3 months after CPAP

07

Study locations

1 site
  • Kyoto University Graduate School of Medicine
    Kyoto, Kyoto, Japan
08

References and documents

Publications

  • 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. PubMed 23222881 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2010, a primary completion of Oct 2011 and a completion of Jan 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 29, 2010
First posted
Mar 31, 2010
Start
May 2010
Primary completionActual
Oct 2011
CompletionActual
Jan 2012
Last update
Jan 26, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 26, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01096433
Lead sponsor
Kyoto University
Responsible party
Yuichi Chihara (Medical doctor, Kyoto University) — Principal investigator
First posted
Mar 31, 2010
Start date
May 2010
Primary completion
Oct 2011
Completion
Jan 2012
Last update
Jan 26, 2012

Study contacts

Kazuo Chin, MD,PhD
principal investigator · Kyoto University, Graduate School of Medicine
Yuichi Chihara, MD
principal investigator · Kyoto University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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