Sleep ApneaNCT00973531
Effect of Treating Sleep Disorder Breathing in Patients With Resistant Hypertension
A study testing Autotitrating Positive Airway Pressure (APAP) and Traditional Split Titration Polysomnogram in people with Sleep Apnea and Hypertension, run by Albert Einstein Healthcare Network at 1 site in United States.
Trial summary
The investigators would like to investigate the effects of treating sleep apnea with a positive airway pressure device, either continuous (titrated) versus auto titrated on the control of blood pressure in patients with Resistant Hypertension. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sleep Apnea, Hypertension
- What is being tested?
- Autotitrating Positive Airway Pressure (APAP) and Traditional Split Titration Polysomnogram
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Oct 2011
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who are competent to provide written consent
- Aged 18 to 80 years
- Deemed to be compliant with anti-hypertension medication therapy.
- Subjects with diabetes and/or chronic kidney disease must have a mean 24 hour systolic blood pressure ≥130 mmHg
- All other subjects must have a mean 24 hour systolic blood pressure ≥140 mmHg
- Receiving and adhering to full doses of appropriate guideline-recommended antihypertensive drugs from three different classes of antihypertensive agents, preferably including a diuretic
Who cannot join
- Average sitting systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg
- Known Sleep apnea
- Subjects who perform alternating shift or night work
- Subjects who have participated in a clinical study involving another investigational drug or device within 4 weeks prior to Screening
- Have hypertension secondary to an identifiable and treatable cause other than sleep apnea
- Subjects taking over the counter medications that can raise blood pressure, such as
Show all 16Show fewer
- Non narcotic analgesics
- Non steroidal anti-inflammatory agents, including aspirin, Selective COX-2 inhibitors
- Sympathomimetic agents (decongestants, diet pills, cocaine)
- Stimulants (methylphenidate, dexmethylphenidate, dextroamphetamine, amphetamine, methamphetamine, modafinil)
- Alcohol
- Oral contraceptives
- Cyclosporine
- Erythropoietin
- Natural licorice
- Herbal compounds (ephedra or ma huang)
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141
About this study
Official title: Effect of Treating Sleep Disorder Breathing Therapy in Patients With Resistant Hypertension
The investigators would like to investigate the effects of treating sleep apnea with a positive airway pressure device, either continuous (titrated) versus auto titrated on the control of blood pressure in patients with Resistant Hypertension.
Read the detailed description
One of the major cause and contributor to stroke, myocardial infarction, heart disease, and kidney disease is high blood pressure. Traditional approaches to control of hypertension (HTN) have mostly included pharmaceuticals targeting different mechanisms that contribute to HTN. However, adequate control of Blood pressure continues to remain a major problem.
Sleep Apnea is currently being recognized as a modifiable risk factor for resistant HTN. Sleep disordered breathing represents states of increased sympathetic drive and vagal tone withdrawal, along with significant episodic hypoxia. There is increasing evidence that sleep apnea is highly prevalent in subjects with hypertension and may be a frequent cause of drug-resistant hypertension.
We propose that we compare strategies for treating subjects with Resistant Hypertension who have SDB as detected by ambulatory multi somnogram and treat subjects using:
- Ambulatory Autotitrating Positive Airway Pressure (APAP) plus Standard medical therapy OR
- Traditional Polysomnogram and Traditional PSG guided titration of Continuous Positive Airway Pressure (CPAP) plus Standard medical therapy
Our hypothesis is that in subjects with Resistant HTN, who have SDB, using the treatment approach of ambulatory multisomnography for testing and then treating with APAP will be noninferior to the traditional polysomnography plus CPAP approach in the amount of reduction of mean systolic and diastolic 24 hour ambulatory blood pressure, when treated for 90 days.
- Conditions
- Sleep Apnea, Hypertension
- Being tested
- Autotitrating Positive Airway Pressure (APAP), Traditional Split Titration Polysomnogram
- Keywords
- Sleep Disordered Breathing, Sleep Apnea, Hypertension, Continuous Positive Airway Pressure
- Medical subject headings
- Sleep Apnea Syndromes, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autotitrating Positive Airway Pressure (APAP)Device
Then subjects will use Autotitrating Positive Airway Pressure machine for 90 days
Traditional Split Titration PolysomnogramDevice
Then subjects will use Continuous Positive Airway Pressure (CPAP) machine for 90 days
| Study group | Role | What they receive |
|---|---|---|
| Ambulatory APAP and SMT | Other | Subjects placed on the APAP machine Receives: Device: Autotitrating Positive Airway Pressure (APAP) |
| Titration Polysomnogram with CPAP and SMT | Other | Subjects placed on CPAP machine Receives: Device: Traditional Split Titration Polysomnogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Noninferiority of the change from baseline to 90 day measurement in mean ambulatory 24-hour systolic ambulatory blood pressure in the Newer approach v/s Traditional Approach
Measured: 90 days
Secondary outcomes (1)
Noninferiority of the change from baseline to 90 day measurement in mean ambulatory 24-hour diastolic ambulatory blood pressure in the Newer approach v/s Traditional Approach
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startMay 2009
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein Healthcare Network
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darshak Karia, MD, Albert Einstein Healthcare Network
- Investigators
- Darshak Karia, MD, Principal investigator, Albert Einstein Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00973531
- Sponsor's protocol ID
- HN 4113
- Status last verified
- Jan 2012
- First submitted
- 2 Sep 2009
- Last updated
- 26 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Treating Sleep Disorder Breathing Therapy in Patients With Resistant Hypertension
- ClinicalTrials.gov ID
- NCT00973531
- Acronym / sponsor ID
- HN 4113
- Conditions
- Sleep Apnea, Hypertension
- Keywords
- Sleep Disordered Breathing, Sleep Apnea, Hypertension, Continuous Positive Airway Pressure
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Albert Einstein Healthcare NetworkUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 9 Sep 2009 (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 investigators would like to investigate the effects of treating sleep apnea with a positive airway pressure device, either continuous (titrated) versus auto titrated on the control of blood pressure in patients with Resistant Hypertension.
Detailed description
One of the major cause and contributor to stroke, myocardial infarction, heart disease, and kidney disease is high blood pressure. Traditional approaches to control of hypertension (HTN) have mostly included pharmaceuticals targeting different mechanisms that contribute to HTN. However, adequate control of Blood pressure continues to remain a major problem.
Sleep Apnea is currently being recognized as a modifiable risk factor for resistant HTN. Sleep disordered breathing represents states of increased sympathetic drive and vagal tone withdrawal, along with significant episodic hypoxia. There is increasing evidence that sleep apnea is highly prevalent in subjects with hypertension and may be a frequent cause of drug-resistant hypertension.
We propose that we compare strategies for treating subjects with Resistant Hypertension who have SDB as detected by ambulatory multi somnogram and treat subjects using:
- Ambulatory Autotitrating Positive Airway Pressure (APAP) plus Standard medical therapy OR
- Traditional Polysomnogram and Traditional PSG guided titration of Continuous Positive Airway Pressure (CPAP) plus Standard medical therapy
Our hypothesis is that in subjects with Resistant HTN, who have SDB, using the treatment approach of ambulatory multisomnography for testing and then treating with APAP will be noninferior to the traditional polysomnography plus CPAP approach in the amount of reduction of mean systolic and diastolic 24 hour ambulatory blood pressure, when treated for 90 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ambulatory APAP and SMT | Other | Device: Autotitrating Positive Airway Pressure (APAP)Subjects placed on the APAP machine |
| Titration Polysomnogram with CPAP and SMT | Other | Device: Traditional Split Titration PolysomnogramSubjects placed on CPAP machine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects who are competent to provide written consent
- Aged 18 to 80 years
- Deemed to be compliant with anti-hypertension medication therapy.
- Subjects with diabetes and/or chronic kidney disease must have a mean 24 hour systolic blood pressure ≥130 mmHg
- All other subjects must have a mean 24 hour systolic blood pressure ≥140 mmHg
Key exclusion criteria (16 listed)
- Average sitting systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg
- Known Sleep apnea
- Subjects who perform alternating shift or night work
- Subjects who have participated in a clinical study involving another investigational drug or device within 4 weeks prior to Screening
- Have hypertension secondary to an identifiable and treatable cause other than sleep apnea
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 |
|---|---|---|
| Autotitrating Positive Airway Pressure (APAP)Then subjects will use Autotitrating Positive Airway Pressure machine for 90 days | Device | Ambulatory APAP and SMT |
| Traditional Split Titration PolysomnogramThen subjects will use Continuous Positive Airway Pressure (CPAP) machine for 90 days | Device | Titration Polysomnogram with CPAP and SMT |
Primary outcome
Noninferiority of the change from baseline to 90 day measurement in mean ambulatory 24-hour systolic ambulatory blood pressure in the Newer approach v/s Traditional Approach
Time frame: 90 days
1 secondary outcome
Noninferiority of the change from baseline to 90 day measurement in mean ambulatory 24-hour diastolic ambulatory blood pressure in the Newer approach v/s Traditional Approach
Time frame: 90 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2012.
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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.
Darshak Karia, MD principal investigator
Albert Einstein Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autotitrating Positive Airway Pressure (APAP) and Traditional Split Titration Polysomnogram in people with Sleep Apnea and Hypertension, run by Albert Einstein Healthcare Network at 1 site in United States.
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 6 inclusion and 16 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: withdrawn, as of the sponsor's last update on 26 Jan 2012. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Noninferiority of the change from baseline to 90 day measurement in mean ambulatory 24-hour systolic ambulatory blood pressure in the Newer approach v/s Traditional Approach (time frame: 90 days). 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 26 Jan 2012.