Obstructive Sleep Apnea SyndromeNCT00284037
Improvement in Baroreflex Sensitivity in OSAS
A study testing continuous positive airway pressure therapy in people with Obstructive Sleep Apnea Syndrome, run by Nagoya University at 1 site in Japan.
Trial summary
Individuals with obstructive sleep apnea syndrome (OSAS) are at high risk for cardiovascular morbidity and mortality. The effect of long-term nocturnal therapy with continuous positive airway pressure (CPAP) on daytime baroreflex sensitivity (BRS), a predictor of cardiac death, was investigated in OSAS patients. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- What is being tested?
- continuous positive airway pressure therapy
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteJapan
- Study dates
- Start not givento not given
- 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 to 70 years
- All sexes
- Adult, Older adult
Who may be able to join
- obstructive sleep apnea syndrome
Who cannot join
- diabetes mellitus, chronic obstructive lung disease, coronary or valvular heart disease, congestive heart failure, renal failure, or endocrine dysfunction. Moreover, none of them were taking b-blockers, vasodilators, or inotropic agents at the time of enrollment in the study.
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Nagoya University of Health Sciences
Nagoya, 461-8673
Akiko Noda, PhD, +81-719-1537, a-noda@met.nagoya-u.ac.jp
Akiko Noda, PhD
About this study
Individuals with obstructive sleep apnea syndrome (OSAS) are at high risk for cardiovascular morbidity and mortality. The effect of long-term nocturnal therapy with continuous positive airway pressure (CPAP) on daytime baroreflex sensitivity (BRS), a predictor of cardiac death, was investigated in OSAS patients.
- Conditions
- Obstructive Sleep Apnea Syndrome
- Being tested
- continuous positive airway pressure therapy
- Keywords
- obstructive sleep apnea,, baroreceptors
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous positive airway pressure therapyDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea SyndromeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Nagoya University
- Sponsor type
- University, hospital or other
- Investigators
- Mitsuhiro Yokota, MD.PhD, Study chair, Department of Cardiovascular Genome Science, Nagoya University School of Medicine, Nagoya, Aichi, Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00284037
- Sponsor's protocol ID
- NU-06-A-0003
- Status last verified
- May 2005
- First submitted
- 27 Jan 2006
- Last updated
- 31 Jan 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement in Baroreflex Sensitivity in OSAS
- ClinicalTrials.gov ID
- NCT00284037
- Acronym / sponsor ID
- NU-06-A-0003
- Conditions
- Obstructive Sleep Apnea Syndrome
- Keywords
- obstructive sleep apnea,, baroreceptors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Nagoya UniversityUniversity, hospital or other
- First posted
- 31 Jan 2006 (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.
Individuals with obstructive sleep apnea syndrome (OSAS) are at high risk for cardiovascular morbidity and mortality. The effect of long-term nocturnal therapy with continuous positive airway pressure (CPAP) on daytime baroreflex sensitivity (BRS), a predictor of cardiac death, was investigated in OSAS patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- obstructive sleep apnea syndrome
Key exclusion criteria (1 listed)
- diabetes mellitus, chronic obstructive lung disease, coronary or valvular heart disease, congestive heart failure, renal failure, or endocrine dysfunction. Moreover, none of them were taking b-blockers, vasodilators, or inotropic agents at the time of enrollment in the study.
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 |
|---|---|---|
| continuous positive airway pressure therapy | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2006.
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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.
Mitsuhiro Yokota, MD.PhD study chair
Department of Cardiovascular Genome Science, Nagoya University School of Medicine, Nagoya, Aichi, Japan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuous positive airway pressure therapy in people with Obstructive Sleep Apnea Syndrome, run by Nagoya 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 31 Jan 2006. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Akiko Noda, PhD (+81-52-719-1537, a-noda@met.nagoya-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 31 Jan 2006.