HypertensionHOSINCT02078778
Central and Peripheral Blood Pressure in Treatment of Obstructive Sleep Apnea.
A study testing CPAP in people with Hypertension and Obstructive Sleep Apnea, run by Erling Bjerregaard Pedersen at 1 site in Denmark.
Trial summary
The purpose of this study is to examine the effect on blood pressure of 3 months of treatment with continuous positive airway pressure (CPAP) in patients with obstructive sleep apnea (OSA). Hypothesis: 1. Read more about this study
- Who is it for?
- Ages 55 to 70 years
- Conditions the study is for
- Hypertension, Obstructive Sleep Apnea
- What is being tested?
- CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2014to Mar 2017
- 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 55 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic kidney disease (CKD stage I and II), eGFR 60-90 ml/min/1.73 m2 or eGFR> 90 ml/min/1.73 m2 and proteinuria or other signs of kidney damage.
- Obstructive sleep apnea, apnea hypopnea index (AHI) > 15 (moderate to severe)
- Both men and women
- 55-70 years
- Signed consent form
Who cannot join
- Lack of desire to participate
- Malignant disease
- Abuse of drugs or alcohol
- Pregnant and breastfeeding
- Incompensated heart failure
- Atrial fibrillation
Show all 9Show fewer
- Liver disease (Alanine aminotransferase (ALT) > 200)
- Severe chronic obstructive pulmonary disease (Forced expiratory volume in 1 second <50% predicted)
- Blood pressure difference between the right and left arm> 10/10 mmHg
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Medical Research and Medicine, Holstebro Regional Hospital
Holstebro, Holstebro, 7500
Bodil Gade Hornstrup, MD, +4578436587, bodil.hornstrup@rm.dk
About this study
Official title: Central and Peripheral 24-h Blood Pressure Monitoring in Patients With Hypertension and Obstructive Sleep Apnea Before and After Treatment With Continuous Positive Airway Pressure.
The purpose of this study is to examine the effect on blood pressure of 3 months of treatment with continuous positive airway pressure (CPAP) in patients with obstructive sleep apnea (OSA).
Hypothesis:
- Central 24-h blood pressure (BP) monitoring hedges day fluctuations in blood pressure more accurately than peripheral 24-h BP monitoring, because the measurement is painless and does not interfere with the patient / subject's activities during the daytime or nighttime sleep.
- Blood pressure is elevated in patients with OSA and falls during treatment with CPAP.
- The renal treatment of salt and water is abnormal in OSA, improved during treatment with CPAP.
- Quality of life improves during treatment with CPAP
Read the detailed description
Approximately 20 patients with hypertension and moderate to severe OSA are treated with CPAP 3 months to examine the treatment effect on blood pressure throughout the day, but especially nocturnal, renal treatment of salt and water, and quality of life.
Before and after 3 months of CPAP treatment is made central and peripheral 24-h ambulatory blood pressure monitoring, 24-h urine collection and blood samples.
- Conditions
- Hypertension, Obstructive Sleep Apnea
- Being tested
- CPAP
- Keywords
- Continuous airway pressure, Hypertension, Obstructive sleep apnea
- Medical subject headings
- Hypertension, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
Also called S9 AutoSet frem ResMed/MAribo Medico, or, REMstar Auto A-Flex frem Phillips/Respirsonics
3 months of CPAP treatment
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Patients with hypertension and moderate to severe OSA is treated with CPAP for 3 months. Receives: Device: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in systolic peripheral BP at night
The difference in systolic BP at night by peripheral BP days before and after 3 months of treatment of OSA with CPAP in patients with hypertension.
Measured: 3 months
Secondary outcomes (6)
Difference i central systolic BP
The difference in systolic BP at night in central BP days before and after 3 months of treatment of OSA with CPAP in patients with hypertension.
Measured: 3 months
Difference i BP throughout the day
The difference in systolic BP and diastolic BP throughout the day, in the daytime and in nighttime between measurements with peripheral and central 24-h blood pressure monitoring before and after 3 months of treatment with CPAP.
Measured: 3 months
Correlation between degree of OSA and kidney function on effect of treatment
The correlation between the treatment effect on blood pressure levels on the one hand and the severity of OSA prior to initiation of treatment and renal function as measured by estimated glomerular filtration rate (eGFR) on the other.
Measured: 3 months
urine auquaporine2 (u-AQP2) and urine epithelial Natrium channel (u-ENaC)
Changes in U-AQP2 and u-ENaC in 24-h urine samples before and after 3 month of treatment.
Measured: 3 months
Plasma renin concentration (PRC), plasma angiotensin II (p-AngII), plasma aldosterone (p-Aldo), plasma vasopressin (P-AVP) and plasma endothelin (p-endothelin).
Changes in PRC, p-AngII, p-Aldo. P-AVP and p-endothelin in blood samples before and after 3 month of treatment.
Measured: 3 months
Quality of life
Changes in the quality of life before and after treatment of OSA with CPAP.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2016 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erling Bjerregaard Pedersen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Erling Bjerregaard Pedersen, Regional Hospital Holstebro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02078778
- Sponsor's protocol ID
- BGH-4-2013
- Other IDs
- M-2013-304-13
- Acronym
- HOSI
- Status last verified
- Jan 2015
- First submitted
- 1 Mar 2014
- Last updated
- 2 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central and Peripheral 24-h Blood Pressure Monitoring in Patients With Hypertension and Obstructive Sleep Apnea Before and After Treatment With Continuous Positive Airway Pressure.
- ClinicalTrials.gov ID
- NCT02078778
- Acronym / sponsor ID
- HOSI / BGH-4-2013
- Conditions
- Hypertension, Obstructive Sleep Apnea
- Keywords
- Continuous airway pressure, Hypertension, Obstructive sleep apnea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Erling Bjerregaard PedersenUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 5 Mar 2014 (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 examine the effect on blood pressure of 3 months of treatment with continuous positive airway pressure (CPAP) in patients with obstructive sleep apnea (OSA).
Hypothesis:
- Central 24-h blood pressure (BP) monitoring hedges day fluctuations in blood pressure more accurately than peripheral 24-h BP monitoring, because the measurement is painless and does not interfere with the patient / subject's activities during the daytime or nighttime sleep.
- Blood pressure is elevated in patients with OSA and falls during treatment with CPAP.
- The renal treatment of salt and water is abnormal in OSA, improved during treatment with CPAP.
- Quality of life improves during treatment with CPAP
Detailed description
Approximately 20 patients with hypertension and moderate to severe OSA are treated with CPAP 3 months to examine the treatment effect on blood pressure throughout the day, but especially nocturnal, renal treatment of salt and water, and quality of life.
Before and after 3 months of CPAP treatment is made central and peripheral 24-h ambulatory blood pressure monitoring, 24-h urine collection and blood samples.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: CPAPPatients with hypertension and moderate to severe OSA is treated with CPAP for 3 months. |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- chronic kidney disease (CKD stage I and II), eGFR 60-90 ml/min/1.73 m2 or eGFR> 90 ml/min/1.73 m2 and proteinuria or other signs of kidney damage.
- Obstructive sleep apnea, apnea hypopnea index (AHI) > 15 (moderate to severe)
- Both men and women
- 55-70 years
- Signed consent form
Key exclusion criteria (9 listed)
- Lack of desire to participate
- Malignant disease
- Abuse of drugs or alcohol
- Pregnant and breastfeeding
- Incompensated heart failure
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 |
|---|---|---|
| CPAPAlso: S9 AutoSet frem ResMed/MAribo Medico, or, REMstar Auto A-Flex frem Phillips/Respirsonics3 months of CPAP treatment | Device | Treatment |
Primary outcome
difference in systolic peripheral BP at night
Time frame: 3 months
The difference in systolic BP at night by peripheral BP days before and after 3 months of treatment of OSA with CPAP in patients with hypertension.
6 secondary outcomes
Difference i central systolic BP
Time frame: 3 months
Difference i BP throughout the day
Time frame: 3 months
Correlation between degree of OSA and kidney function on effect of treatment
Time frame: 3 months
urine auquaporine2 (u-AQP2) and urine epithelial Natrium channel (u-ENaC)
Time frame: 3 months
Plasma renin concentration (PRC), plasma angiotensin II (p-AngII), plasma aldosterone (p-Aldo), plasma vasopressin (P-AVP) and plasma endothelin (p-endothelin).
Time frame: 3 months
Quality of life
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2015.
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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.
Department of Medical Research and Medicine, Holstebro Regional Hospital
Holstebro, Denmark
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 in people with Hypertension and Obstructive Sleep Apnea, run by Erling Bjerregaard Pedersen 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 5 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: status not confirmed, as of the sponsor's last update on 2 Feb 2015. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference in systolic peripheral BP at night (time frame: 3 months). It is what the study was designed to measure, not a finding.
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 2 Feb 2015.