HealthyNCT00291993
Vasoactive Hormones During the Night in Patients With Obstructive Sleep Apnea and Healthy Controls.
An observational study of Healthy and Obstructive Sleep Apnea, run by Regional Hospital Holstebro at 3 sites in Denmark.
Trial summary
Obstructive sleep apnea syndrome is complicated by considerable cardiovascular morbidity and mortality, at least partly due to hypertension. Nocturnal hypoxia, hypercapnia and acidosis stimulate chemoreceptors and presumably increased secretion of vasoactive hormones which might be responsible for hypertension in… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Obstructive Sleep Apnea
- How many people
- Not given
- Where
- 3 sitesDenmark
- Study dates
- Jan 2004to not given
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female Age 20-65 Obstructive sleep apnea
Who cannot join
- Drug or alcohol abuse Pregnancy or breast feeding Cancer Clinical signs or history of disease in the heart, lungs, kidney or endocrine organs Abnormal laboratory tests Albuminuria or glucosuria Aterial hypertension for healthy subjects
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Department of Medical Research, Holstebro Hospital
Holstebro, Ringkoebing County, 7500
Department of Medical Research
Holstebro, 7500
Holstebro Hospital, Department of Medical Research
Holstebro, 7500
About this study
Obstructive sleep apnea syndrome is complicated by considerable cardiovascular morbidity and mortality, at least partly due to hypertension. Nocturnal hypoxia, hypercapnia and acidosis stimulate chemoreceptors and presumably increased secretion of vasoactive hormones which might be responsible for hypertension in these patients.
The aim of this study is to measure the secretion of vasoactive hormones at night and to analyse the relationship between vasoactive hormones, oxygen saturation and the blood pressure at night.
- Conditions
- Healthy, Obstructive Sleep Apnea
- Keywords
- Obstructive sleep apnea, Vasoactive hormones, Blood pressure
- Medical subject headings
- Sleep Apnea, Obstructive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2006 (estimated)
- Study startJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Observational
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Regional Hospital Holstebro
- Sponsor type
- University, hospital or other
- Investigators
- Erling B Pedersen, Professor, Study chair, Holstebro Hospital, Department of Medical ResearchPia H Hansen, MD, Principal investigator, Holstebro Hospital, Department of Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00291993
- Sponsor's protocol ID
- MED.RES.HOS.2004.01.PHH
- Status last verified
- Apr 2008
- First submitted
- 13 Feb 2006
- Last updated
- 21 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vasoactive Hormones During the Night in Patients With Obstructive Sleep Apnea and Healthy Controls.
- ClinicalTrials.gov ID
- NCT00291993
- Acronym / sponsor ID
- MED.RES.HOS.2004.01.PHH
- Conditions
- Healthy, Obstructive Sleep Apnea
- Keywords
- Obstructive sleep apnea, Vasoactive hormones, Blood pressure
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Regional Hospital HolstebroUniversity, hospital or other
- Study start
- Jan 2004
- First posted
- 15 Feb 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.
Obstructive sleep apnea syndrome is complicated by considerable cardiovascular morbidity and mortality, at least partly due to hypertension. Nocturnal hypoxia, hypercapnia and acidosis stimulate chemoreceptors and presumably increased secretion of vasoactive hormones which might be responsible for hypertension in these patients.
The aim of this study is to measure the secretion of vasoactive hormones at night and to analyse the relationship between vasoactive hormones, oxygen saturation and the blood pressure at night.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male and female Age 20-65 Obstructive sleep apnea
Key exclusion criteria (1 listed)
- Drug or alcohol abuse Pregnancy or breast feeding Cancer Clinical signs or history of disease in the heart, lungs, kidney or endocrine organs Abnormal laboratory tests Albuminuria or glucosuria Aterial hypertension for healthy subjects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 21 Apr 2008.
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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.
Erling B Pedersen, Professor study chair
Holstebro Hospital, Department of Medical Research
Pia H Hansen, MD principal investigator
Holstebro Hospital, Department of Medical Research
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Obstructive Sleep Apnea, run by Regional Hospital Holstebro at 3 sites in Denmark.
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: finished, as of the sponsor's last update on 21 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. 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.
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 21 Apr 2008.