Obstructive Sleep ApneaPhase 4NCT00360659
Vasoactive Hormones During the Night in Patients With Obstructive Sleep Apnea Before and After Treatment With CPAP.
A Phase 4 study testing Continuous Positive Airway Pressure in people with Obstructive Sleep Apnea, run by Regional Hospital Holstebro at 1 site in Denmark.
Trial summary
We wanted to test the hypothesis that treatment with continuous positive airway pressure reduces nocturnal hypoxia and thereby affecting levels of vasoactive hormones leading to a fall in blood pressure patients with obstructive sleep apnea. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Continuous Positive Airway Pressure
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2004to Feb 2005
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 20 and 65 years
- Obstructive sleep apnea
- Hypertension or normal blood pressure
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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Medicine, Holstebro Hospital
Holstebro, Ringkoebing County, 7500
About this study
We wanted to test the hypothesis that treatment with continuous positive airway pressure reduces nocturnal hypoxia and thereby affecting levels of vasoactive hormones leading to a fall in blood pressure patients with obstructive sleep apnea.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Continuous Positive Airway Pressure
- Keywords
- Obstructive sleep Apnea, Hypertension, Vasoactive hormones
- Medical subject headings
- Sleep Apnea, Obstructive, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Positive Airway PressureDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2006 (estimated)
- Study startFeb 2004
- Study completionFeb 2005
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
- Interventional
- Phase
- Phase 4
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants
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
- NCT00360659
- Sponsor's protocol ID
- MED.RES.HOS.2004.02.PHH
- Status last verified
- Apr 2008
- First submitted
- 3 Aug 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 Before and After Treatment With CPAP.
- ClinicalTrials.gov ID
- NCT00360659
- Acronym / sponsor ID
- MED.RES.HOS.2004.02.PHH
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive sleep Apnea, Hypertension, Vasoactive hormones
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- Regional Hospital HolstebroUniversity, hospital or other
- Study start
- Feb 2004
- Study completion
- Feb 2005
- First posted
- 4 Aug 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.
We wanted to test the hypothesis that treatment with continuous positive airway pressure reduces nocturnal hypoxia and thereby affecting levels of vasoactive hormones leading to a fall in blood pressure patients with obstructive sleep apnea.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 20 and 65 years
- Obstructive sleep apnea
- Hypertension or normal blood pressure
Key exclusion criteria (4 listed)
- Drug or alcohol abuse
- Pregnancy
- History or clinical signs of disease in the heart, lungs, brain,liver, kidneys or endocrine organs
- Diabetes
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 | Device | – |
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.
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
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?
A Phase 4 study testing Continuous Positive Airway Pressure in people with 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 3 inclusion and 4 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.