Sleep ApneaNCT01096433
Circadian Variations of Prostaglandin in Sleep Apnea
A study testing CPAP treatment in people with Sleep Apnea and Continuous Positive Airway Pressure, run by Kyoto University at 1 site in Japan.
Trial 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 more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Sleep Apnea, Continuous Positive Airway Pressure, Prostaglandins
- What is being tested?
- CPAP treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteJapan
- Study dates
- May 2010to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Circadian Variations,Sleep Architecture, Hypertension, and Prostaglandin in Sleep Apnea
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.
- Being tested
- CPAP treatment
- Keywords
- Sleep apnea, CPAP, Prostaglandins, Circadian variations
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP treatmentDevice
Also called REMstar (Respironics), Auto Set(Resmed), Goodnight (Tyco Healthcare)
maintains upper airway patency and minimizes the obstructive events
| Study group | Role | What they receive |
|---|---|---|
| CPAP | Experimental | The subjects introduced with CPAP treatment Receives: Device: CPAP treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostaglandins in the urine and blood
Measured: baseline, and 2days, 3 months after CPAP
Secondary outcomes (5)
polysomnography measurements
Measured: baseline, and 2days, 3 months after CPAP
sleepiness and health-related quality of life
Measured: baseline, and 2days, 3 months after CPAP
Clinical measurements (blood pressure, heart rate, sympathetic activity etc)
Measured: baseline, and 2days, 3 months after CPAP
serum and urinary biomarker (inflammation, oxidative stress etc.)
Measured: baseline, and 2days, 3 months after CPAP
endothelial function
Measured: baseline, and 2days, 3 months after CPAP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2010 (estimated)
- Study startMay 2010
- Primary completionOct 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyoto University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuichi Chihara, Kyoto University
- Investigators
- Kazuo Chin, MD,PhD, Principal investigator, Kyoto University, Graduate School of MedicineYuichi Chihara, MD, Principal investigator, Kyoto University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01096433
- Sponsor's protocol ID
- C-411
- Status last verified
- Jan 2012
- First submitted
- 29 Mar 2010
- Last updated
- 26 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Circadian Variations,Sleep Architecture, Hypertension, and Prostaglandin in Sleep Apnea
- ClinicalTrials.gov ID
- NCT01096433
- Acronym / sponsor ID
- C-411
- Keywords
- Sleep apnea, CPAP, Prostaglandins, Circadian variations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Kyoto UniversityUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 31 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPAP | Experimental | Device: CPAP treatmentThe subjects introduced with CPAP treatment |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAP treatmentAlso: REMstar (Respironics), Auto Set(Resmed), Goodnight (Tyco Healthcare)maintains upper airway patency and minimizes the obstructive events | Device | CPAP |
Primary outcome
Prostaglandins in the urine and blood
Time frame: baseline, and 2days, 3 months after CPAP
5 secondary outcomes
polysomnography measurements
Time frame: baseline, and 2days, 3 months after CPAP
sleepiness and health-related quality of life
Time frame: baseline, and 2days, 3 months after CPAP
Clinical measurements (blood pressure, heart rate, sympathetic activity etc)
Time frame: baseline, and 2days, 3 months after CPAP
serum and urinary biomarker (inflammation, oxidative stress etc.)
Time frame: baseline, and 2days, 3 months after CPAP
endothelial function
Time frame: baseline, and 2days, 3 months after CPAP
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2012.
- Derived from this study: PubMed 23222881Chihara 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kazuo Chin, MD,PhD principal investigator
Kyoto University, Graduate School of Medicine
Yuichi Chihara, MD principal investigator
Kyoto University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP treatment in people with Sleep Apnea and Continuous Positive Airway Pressure, run by Kyoto University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prostaglandins in the urine and blood (time frame: baseline, and 2days, 3 months after CPAP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01096433, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2012.