Resistant HypertensionNCT01044355
Effect of Continuous Positive Airway Pressure (CPAP) Versus Auto-titrating Continuous Positive Airway Pressure (APAP) on Resistant Hypertension (HTN) and Arterial Stiffness
A study testing CPAP and APAP in people with Resistant Hypertension and Obstructive Sleep Apnea, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 2 sites in Canada.
Trial summary
The primary objective is to evaluate the relative effectiveness of fixed CPAP in comparison to APAP in reducing arterial blood pressure in patients with resistant hypertension and obstructive sleep apnea (OSA). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Resistant Hypertension, Obstructive Sleep Apnea
- What is being tested?
- CPAP and APAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesCanada
- Study dates
- Dec 2009to Jan 2020
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Resistant Hypertension
- Moderate Obstructive Sleep Apnea
Who cannot join
- Creatinine >150 μmol/l
- Systolic blood pressure > 170 mmHg
- Diastolic blood pressure > 105 mmHg
- Secondary cause of hypertension other than OSA
- Treatment within the last 3 months or current treatment for sleep-disordered breathing or some other sleep disorder
- Current treatment or recent treatment within the last 3 months for any other medical condition which has resulted or would be expected to result in a change in blood pressure medications
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Royal Victoria Hospital
Montreal, Quebec, H3A 1A1
Montreal General Hospital
Montreal, Quebec, H3G 1A4
About this study
Official title: Effect of Fixed Versus Auto-titrating Continuous Positive Airway Pressure on Blood Pressure and Arterial Stiffness in Patients With Resistant Hypertension and Obstructive Sleep Apnea
The primary objective is to evaluate the relative effectiveness of fixed CPAP in comparison to APAP in reducing arterial blood pressure in patients with resistant hypertension and obstructive sleep apnea (OSA).
The secondary objectives are: a) to evaluate the relative effectiveness of fixed CPAP versus APAP in improving arterial stiffness, sleep-disordered breathing, sleep quality, inflammatory markers and glucose regulation; b) to identify specific characteristic of persons who respond to the two CPAP modalities in order to identify which device is better for each subject.
Read the detailed description
The confirmatory hypothesis is that subjects with resistant hypertension and OSA will show a greater degree of blood pressure reduction after 6 weeks of treatment with fixed CPAP in comparison to those treated with APAP. Explanatory and exploratory hypotheses are that a greater reduction in arterial stiffness will be noted when compared with the benefit in blood pressure, that reductions in arterial stiffness will be associated with benefits to serum measurements of inflammatory markers and glucose regulation, and that control of sleep apnea and the attendant improvement in sleep quality will be better with fixed CPAP than APAP.
- Conditions
- Resistant Hypertension, Obstructive Sleep Apnea
- Being tested
- CPAP, APAP
- Keywords
- Resistant Hypertension, Obstructive Sleep Apnea, 24 Hour Blood Pressure, Arterial Stiffness, Insulin Resistance, CPAP, APAP
- Medical subject headings
- Sleep Apnea, Obstructive, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
Also called Continuous Positive Airway Pressure
6 weeks treatment with fixed CPAP
APAPDevice
Also called auto-titrating airway pressure
6 weeks of treatment with auto-titrating positive airway pressure
| Study group | Role | What they receive |
|---|---|---|
| auto-titrating | Active comparator | Patients being treated for 6 weeks with auto-titrating continuous airway pressure. Receives: Device: APAP |
| Fixed | Active comparator | Patients receiving 6 weeks of treatment with fixed continuous positive airway pressure. Receives: Device: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hour blood pressure.
Measured: 6 weeks and 12 weeks after initial intervention
Secondary outcomes (3)
Non-invasive measures of arterial stiffness using applanation tonometry.
Measured: 6 weeks and 12 weeks after initial intervention
Standard measures of OSA severity, including AHI and measures of nocturnal oxygenation and sleep quality using polysomnography.
Measured: 6 weeks and 12 weeks after initial intervention
Blood tests to assess levels of aldosterone, hsCRP, fasting glucose, HbA1c, and plasma insulin.
Measured: 6 weeks and 12 weeks after initial intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2010 (estimated)
- Study startDec 2009
- Primary completionJan 2014
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistant HypertensionStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- OSR Medical Inc.
- Responsible party
- Principal investigator, Dr. Stella Daskalopoulou, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Stella S Daskalopoulou, MD, MSc, PHd, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentreR John Kimoff, MD, FRCP(C), Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01044355
- Sponsor's protocol ID
- 09-038-SDR (SARHT 1001)
- Status last verified
- Mar 2018
- First submitted
- 6 Jan 2010
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fixed Versus Auto-titrating Continuous Positive Airway Pressure on Blood Pressure and Arterial Stiffness in Patients With Resistant Hypertension and Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT01044355
- Acronym / sponsor ID
- 09-038-SDR (SARHT 1001)
- Conditions
- Resistant Hypertension, Obstructive Sleep Apnea
- Keywords
- Resistant Hypertension, Obstructive Sleep Apnea, 24 Hour Blood Pressure, Arterial Stiffness, Insulin Resistance, CPAP, APAP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- OSR Medical Inc.
- Study start
- Dec 2009
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2020 (estimated)
- First posted
- 7 Jan 2010 (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 primary objective is to evaluate the relative effectiveness of fixed CPAP in comparison to APAP in reducing arterial blood pressure in patients with resistant hypertension and obstructive sleep apnea (OSA).
The secondary objectives are: a) to evaluate the relative effectiveness of fixed CPAP versus APAP in improving arterial stiffness, sleep-disordered breathing, sleep quality, inflammatory markers and glucose regulation; b) to identify specific characteristic of persons who respond to the two CPAP modalities in order to identify which device is better for each subject.
Detailed description
The confirmatory hypothesis is that subjects with resistant hypertension and OSA will show a greater degree of blood pressure reduction after 6 weeks of treatment with fixed CPAP in comparison to those treated with APAP. Explanatory and exploratory hypotheses are that a greater reduction in arterial stiffness will be noted when compared with the benefit in blood pressure, that reductions in arterial stiffness will be associated with benefits to serum measurements of inflammatory markers and glucose regulation, and that control of sleep apnea and the attendant improvement in sleep quality will be better with fixed CPAP than APAP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| auto-titrating | Active comparator | Device: APAPPatients being treated for 6 weeks with auto-titrating continuous airway pressure. |
| Fixed | Active comparator | Device: CPAPPatients receiving 6 weeks of treatment with fixed continuous positive airway pressure. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Resistant Hypertension
- Moderate Obstructive Sleep Apnea
Key exclusion criteria (6 listed)
- Creatinine >150 μmol/l
- Systolic blood pressure > 170 mmHg
- Diastolic blood pressure > 105 mmHg
- Secondary cause of hypertension other than OSA
- Treatment within the last 3 months or current treatment for sleep-disordered breathing or some other sleep disorder
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: Continuous Positive Airway Pressure6 weeks treatment with fixed CPAP | Device | Fixed |
| APAPAlso: auto-titrating airway pressure6 weeks of treatment with auto-titrating positive airway pressure | Device | auto-titrating |
Primary outcome
24 hour blood pressure.
Time frame: 6 weeks and 12 weeks after initial intervention
3 secondary outcomes
Non-invasive measures of arterial stiffness using applanation tonometry.
Time frame: 6 weeks and 12 weeks after initial intervention
Standard measures of OSA severity, including AHI and measures of nocturnal oxygenation and sleep quality using polysomnography.
Time frame: 6 weeks and 12 weeks after initial intervention
Blood tests to assess levels of aldosterone, hsCRP, fasting glucose, HbA1c, and plasma insulin.
Time frame: 6 weeks and 12 weeks after initial intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
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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.
Stella S Daskalopoulou, MD, MSc, PHd principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
R John Kimoff, MD, FRCP(C) principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP and APAP in people with Resistant Hypertension and Obstructive Sleep Apnea, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 2 sites in Canada.
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 6 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 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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.
What does the primary outcome measure?
24 hour blood pressure. (time frame: 6 weeks and 12 weeks after initial intervention). 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 22 Mar 2018; AzTrials last refreshed its copy on 7 Nov 2026.