Obstructive Sleep ApneaNCT00438412
Vasoactive Hormones and Oxygen Saturation During Apneic Events in Patients With Obstructive Sleep Apnea
An observational study of Obstructive Sleep Apnea, run by Regional Hospital Holstebro at 1 site in Denmark.
Trial summary
The mechanisms involved in development and maintenance of hypertension in obstructive sleep apnea are not clarified. We hypothesize that patients with obstructive sleep apnea have an abnormal level of some vasoactive hormones during apneic events during sleep. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2006to 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
Study population: Adults, males and females,age 30 -65
Who may be able to join
- Severe obstructive sleep apnea (apnea-hypopnea index > 30)
- Apnea-hypopnea index < 10
Who cannot join
- Drug or alcohol abuse
- Pregnancy
- History or clinical signs of disease in the heart, lungs, brain, liver, kidneys or endocrine organs
- Diabetes
- Healthy Controls
- Drug or alcohol abuse
Show all 9Show fewer
- Pregnancy
- History or clinical signs of disease in the heart, lungs, brain, liver, kidneys or endocrine organs
- Diabetes
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Medical Research, Holstebro Hospital
Holstebro, 7500
About this study
The mechanisms involved in development and maintenance of hypertension in obstructive sleep apnea are not clarified.
We hypothesize that patients with obstructive sleep apnea have an abnormal level of some vasoactive hormones during apneic events during sleep.
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Noradrenalin, Endothelin-1, Angiotensin II, Arginine vasopressin, Aldosterone, Renin, Atrial natriuretic peptide, Brain natriuretic peptide, Blood pressure, Apnea
- Medical subject headings
- Sleep Apnea, Obstructive, Diabetes Insipidus, Apnea
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2007 (estimated)
- Study startOct 2006
Why it stopped: It was not possible to recruit enough patients with obstructive sleep apnea.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regional Hospital Holstebro
- Sponsor type
- University, hospital or other
- Investigators
- Erling B Pedersen, Professor, Study chair, Regional Hospital Holstebro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00438412
- Sponsor's protocol ID
- MED.RES.HOS.2006.01.PHH
- Status last verified
- Apr 2008
- First submitted
- 20 Feb 2007
- Last updated
- 22 Apr 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vasoactive Hormones and Oxygen Saturation During Apneic Events in Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT00438412
- Acronym / sponsor ID
- MED.RES.HOS.2006.01.PHH
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Noradrenalin, Endothelin-1, Angiotensin II, Arginine vasopressin, Aldosterone, Renin, Atrial natriuretic peptide, Brain natriuretic peptide
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: It was not possible to recruit enough patients with obstructive sleep apnea.
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Regional Hospital HolstebroUniversity, hospital or other
- Study start
- Oct 2006
- First posted
- 22 Feb 2007 (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 mechanisms involved in development and maintenance of hypertension in obstructive sleep apnea are not clarified.
We hypothesize that patients with obstructive sleep apnea have an abnormal level of some vasoactive hormones during apneic events during sleep.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults, males and females,age 30 -65
Key inclusion criteria (2 listed)
- Severe obstructive sleep apnea (apnea-hypopnea index > 30)
- Apnea-hypopnea index < 10
Key exclusion criteria (9 listed)
- Drug or alcohol abuse
- Pregnancy
- History or clinical signs of disease in the heart, lungs, brain, liver, kidneys or endocrine organs
- Diabetes
- Healthy Controls
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 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
Regional Hospital Holstebro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Regional Hospital Holstebro at 1 site 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 2 inclusion and 9 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: paused, as of the sponsor's last update on 22 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 1 site 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?
Results are not available in the source record.
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 22 Apr 2008.