Sleep Apnea, ObstructiveCOMETNCT01461473
Comparative Outcomes Management With Electronic Data Technology (COMET) Study
A study testing Positive Airway Pressure (PAP) and Oral Appliance (OA) in people with Sleep Apnea, Obstructive, run by Stanford University at 4 sites in United States.
Trial summary
STAGE I of the COMET study was to develop an Electronic Network Informatics Infrastructure that prospectively enabled access to and the sharing of clinical and research data. STAGE II: This was a Comparative Effectiveness Trial (CET) evaluating positive airway pressure (PAP) vs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Positive Airway Pressure (PAP) and Oral Appliance (OA)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2011to Jun 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years.
- BMI > = 25.0 kg/m^2.
- A diagnosis of obstructive sleep apnea based upon medical history and apnea- hypopnea index > = 10.0 or oxygen desaturation index (ODI; ≥4%) ≥ 10.0 on Diagnostic Polysomnogram.
- Report a history of hypertension (or need for treatment for hypertension) which is currently untreated OR taking medication for the treatment of hypertension.
- Stable medication regimen for 2 months prior to the Baseline Testing Visit. As-needed medications such as those used for allergy, cold, or minor pain symptoms may be used at the discretion of the Clinical Center physician.
Who cannot join
- Cardiovascular disease which, in the judgment of the investigator, if observed during standard clinical practice would lead the treating physician to make every effort to treat the patient's sleep apnea with positive airway pressure, rather than alternative treatments.
- Clinically significant acute or chronic disease that is not well controlled or could affect ability to complete or comply with study procedures, in the opinion of the Clinical Center physician.
- Respiratory disease requiring supplemental oxygen or medication. Individuals with asthma may be included at the discretion of the Clinical Center physician if disease is well controlled and medications are stable for 2 months.
- History of (within 12 months prior to enrollment), or current diagnosis of, Axis I or Axis II psychiatric disorder (other than obstructive sleep apnea) that in the opinion of the Clinical Center physician would affect ability to complete or comply with study procedures (e.g., schizophrenia and other psychotic disorders).
- History of (within 3 months prior to enrollment), or current diagnosis of narcolepsy, idiopathic hypersomnia, restless legs syndrome, rapid eye movement (REM) behavior disorder, persistent situational insomnia, or sleep-related breathing disorders other than obstructive sleep apnea.
- Periodic limb movement arousal index > 10.0 on the Diagnostic Polysomnogram.
Show all 20Show fewer
- Significant daytime sleepiness at study entry as indicated by:
- an Epworth Sleepiness Scale total score > 16, or a score of 3 (high chance) on the question about risk of dozing "In a car, while stopped for a few minutes in traffic" or
- a report of falling asleep at the wheel, a motor vehicle accident, or near-miss accident due to sleepiness in the past 24 months, which in the judgment of the study physician was not attributable to acute sleep loss.
- Oxygen saturation < 80% for > 10% of sleep time during the Diagnostic Polysomnogram, or intervention with positive airway pressure or oxygen for safety purposes during the Diagnostic Polysomnogram.
- Any prior treatment for obstructive sleep apnea with positive airway pressure or oral appliance, or surgical treatment for obstructive sleep apnea in the past year.
- Contraindication for treatment with either positive airway pressure or oral appliance, in the opinion of the Clinical Center physician or dentist, including significant nasal obstruction, insufficient or loose teeth, dentures, advanced periodontal disease, or significant temporomandibular joint pain.
- Pregnancy.
- Difficulty understanding or speaking English, or inability to read and understand informed consent and study procedures.
- Significant vision, hearing, or motor problems that, in the opinion of the Clinical Center physician, would affect ability to complete study procedures.
- A work schedule that does not allow for nighttime sleep on the 3 nights before each study visit.
- Current or planned participation in another research study.
- Metal objects, devices, or implants that are in or on the body (Stanford Clinical Center only).
- Creatinine clearance <30 and creatinine >1.6 (Stanford Clinical Center only).
- Upper arm circumference > 20 inches
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Harvard Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of Wisconsin-Madison School of Medicine, Department of Psychiatry
Madison, Wisconsin, 53719
Center for Sleep and Circadian Neurobiology, University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, 19104
Stanford Sleep Medicine Center
Redwood City, California, 94063
About this study
Official title: R01: Comparative Outcomes Management With Electronic Data Technology (COMET) Study
STAGE I of the COMET study was to develop an Electronic Network Informatics Infrastructure that prospectively enabled access to and the sharing of clinical and research data.
STAGE II: This was a Comparative Effectiveness Trial (CET) evaluating positive airway pressure (PAP) vs. oral appliance (OA) therapy in improving hypertension and abnormalities in cardiovascular function in overweight/obese patients with obstructive sleep apnea (OSA). Data collected during the STAGE II study was incorporated in Part 3 of the STAGE I study.
STAGE III of the COMET study was completion of data analysis and preparation of the electronic network informatics infrastructure for use beyond the four Clinical Centers to interested CTSA institutions. We also explored expanding ontologies, and the use of federated database methodology.
Read the detailed description
STAGE I, Part 1: We extracted limited access data sets from an existing research database (prior research patients' data from APPLES research project, where patients consented to provide a limited access data sets to the public domain as required by grants funded by the National Heart, Lung, and Blood Institute [NHLBI], PI: Dr. Clete Kushida) and a dummy database with prepared test data (no real patient data) to evaluate and refine the initial iterations of the informatics infrastructure created via an agile evolutionary development process.
STAGE I, Part 2: We expanded the functionality of the informatics infrastructure by testing its ability to incorporate research data collected from an electronic questionnaire, the Alliance Sleep Questionnaire (ASQ). We enabled data collection using the ASQ in order to use these data to evaluate and refine the iterations for the informatics infrastructure.
STAGE I, Part 3: We expanded the functionality of the informatics infrastructure by testing its ability to incorporate live (ongoing) longitudinal data collected from multiple forms and data sources obtained during the STAGE II study. The addition of these data allowed the COMET Steering Committee to create use cases with a greater diversity of data content. The STAGE II data were used to evaluate and refine the iterations for the expanded informatics infrastructure.
STAGE I, Part 4: Part 4 was designed to expand the collection of data beyond individual research studies, tapping into University-wide systems (e.g., Stride) to link longitudinal data collected during research studies to longitudinal data collected during clinical visits. Only de-identified data were shared with the network, and only the local site held the codebook that translated the Global Identifier (ID) to the Participant ID. All Health Insurance Portability and Accountability Act (HIPAA) regulations were considered.
STAGE II: This stage was comprised of the multicenter, randomized, parallel group, comparative effectiveness trial to compare positive airway pressure (PAP) vs. oral appliance (OA) therapy in improving hypertension and abnormalities in cardiovascular function in overweight/obese patients with obstructive sleep apnea (OSA). Data collected during the STAGE II study were incorporated in Part 3 of the STAGE I study. This comparative effectiveness trial was conducted at 4 clinical centers, and the data collected during this trial were used to test the electronic network informatics infrastructure. The primary aim of the Stage II CET was to evaluate and compare the effect of positive airway pressure and oral appliance therapy on 24-hour blood pressure and vascular structure and function associated with obstructive sleep apnea in a primarily female, overweight/obese hypertensive population.
STAGE III: This stage was comprised of completion of data analysis and preparation of the electronic network informatics infrastructure for deployment beyond the four Clinical Centers to interested Clinical and Translational Science Awards (CTSA) institutions. We also explored expanding the ontologies beyond a sleep-related ontology to other medical ontologies, and the use of federated database methodology.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Positive Airway Pressure (PAP), Oral Appliance (OA)
- Keywords
- Obstructive Sleep Apnea, Obstructive Sleep Apnea Syndrome, Sleep Apnea Syndrome, Obstructive, Syndrome, Obstructive Sleep Apnea, Syndrome, Sleep Apnea, Obstructive, Syndrome, Upper Airway Resistance, Sleep Apnea, Upper Airway Resistance Sleep Apnea Syndrome
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Airway Pressure (PAP)Device
Also called Auto-titrating PAP (APAP), Continuous PAP (CPAP)
Participants randomized to the Positive Airway Pressure treatment group received adequate Positive Airway Pressure (PAP) pressure therapy by a PAP titration study and used the device for 6 months.
Oral Appliance (OA)Device
Also called Mandibular Advancement Device
Participants randomized to the Oral Appliance treatment group received a dental evaluation to determine the optimal setting for the Oral Appliance (OA), and used the appliance for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Positive Airway Pressure | Active comparator | Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA). Receives: Device: Positive Airway Pressure (PAP) |
| Oral Appliance | Active comparator | Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA). Receives: Device: Oral Appliance (OA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nocturnal Mean Arterial Blood Pressure (NMAP) at 2 Months
Mean arterial blood pressure during the sleep period as recorded by 24-hour ambulatory blood pressure monitoring after approximately 2 months of treatment
Measured: 2 months
Secondary outcomes (5)
Nocturnal Mean Arterial Blood Pressure (NMAP) at 6 Months
Nocturnal mean arterial blood pressure as recorded by 24-hour ambulatory blood pressure monitoring after approximately 6 months of treatment
Measured: 6 months
Ratio of Nocturnal Mean Arterial Pressure (NMAP) to Daytime Mean Arterial Pressure at 2 Months
Ratio of NMAP to mean daytime arterial pressure, expressed as a percentage at the 2 month visit for PAP and OA arms. The ratio is calculated by dividing the NMAP by the daytime mean arterial pressure; the result is then multiplied by 100 to obtain a percentage.
Measured: 2 months
Ratio of NMAP to Daytime Mean Arterial Pressure at 6 Months
Ratio of NMAP to daytime mean arterial pressure, expressed as a percentage at the 6 month visit for PAP and OA arms. The ratio is calculated by dividing the NMAP by the daytime mean arterial pressure; the result is then multiplied by 100 to obtain a percentage.
Measured: 6 months
Mean Absolute Flow-Mediated Vasodilatation of the Brachial Artery by Vascular Ultrasound
Mean absolute flow-mediated vasodilatation (FMD) of the brachial artery (i.e., the mean change in brachial artery diameter [in millimeters] from baseline to the value that is obtained after the cuff deflation) as measured by vascular ultrasound (VU) at the 6-month visit
Measured: 6 months
Mean Relative Flow-Mediated Vasodilatation of the Brachial Artery by Vascular Ultrasound
Mean relative flow-mediated vasodilatation (FMD) of the brachial artery (i.e., the mean change in brachial artery diameter from baseline to the value that is obtained after the cuff deflation, divided by the baseline value and multiplied by 100) as measured by vascular ultrasound (VU) at the 6-month visit
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2011 (estimated)
- Study startDec 2011
- Primary completionMay 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clete A. Kushida, Stanford University
- Investigators
- Clete A Kushida, MD, PhD, Study director, Stanford UniversityAllan Pack, MD, Principal investigator, Center for Sleep, University of Pennsylvania School of MedicineSusan Redline, MD, Principal investigator, Harvard Brigham and Women's HospitalRuth Benca, MD, Principal investigator, University of Wisconsin-Madison School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01461473
- Sponsor's protocol ID
- SU-10182011-8536
- Other IDs
- 1R01HS019738-01
- Acronym
- COMET
- Status last verified
- Apr 2017
- First submitted
- 20 Oct 2011
- Last updated
- 17 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. doi: 10.1056/NEJM199304293281704.
PubMed 8464434Nichols DA, DeSalvo S, Miller RA, Jonsson D, Griffin KS, Hyde PR, Walsh JK, Kushida CA. The COMET Sleep Research Platform. EGEMS (Wash DC). 2014 Nov 24;2(1):1059. doi: 10.13063/2327-9214.1059. eCollection 2014.
PubMed 25848590
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- R01: Comparative Outcomes Management With Electronic Data Technology (COMET) Study
- ClinicalTrials.gov ID
- NCT01461473
- Acronym / sponsor ID
- COMET / SU-10182011-8536
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Obstructive Sleep Apnea, Obstructive Sleep Apnea Syndrome, Sleep Apnea Syndrome, Obstructive, Syndrome, Obstructive Sleep Apnea, Syndrome, Sleep Apnea, Obstructive, Syndrome, Upper Airway Resistance, Sleep Apnea, Upper Airway Resistance Sleep Apnea Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 28 Oct 2011 (estimated)
- Results
- Posted 17 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
STAGE I of the COMET study was to develop an Electronic Network Informatics Infrastructure that prospectively enabled access to and the sharing of clinical and research data.
STAGE II: This was a Comparative Effectiveness Trial (CET) evaluating positive airway pressure (PAP) vs. oral appliance (OA) therapy in improving hypertension and abnormalities in cardiovascular function in overweight/obese patients with obstructive sleep apnea (OSA). Data collected during the STAGE II study was incorporated in Part 3 of the STAGE I study.
STAGE III of the COMET study was completion of data analysis and preparation of the electronic network informatics infrastructure for use beyond the four Clinical Centers to interested CTSA institutions. We also explored expanding ontologies, and the use of federated database methodology.
Detailed description
STAGE I, Part 1: We extracted limited access data sets from an existing research database (prior research patients' data from APPLES research project, where patients consented to provide a limited access data sets to the public domain as required by grants funded by the National Heart, Lung, and Blood Institute [NHLBI], PI: Dr. Clete Kushida) and a dummy database with prepared test data (no real patient data) to evaluate and refine the initial iterations of the informatics infrastructure created via an agile evolutionary development process.
STAGE I, Part 2: We expanded the functionality of the informatics infrastructure by testing its ability to incorporate research data collected from an electronic questionnaire, the Alliance Sleep Questionnaire (ASQ). We enabled data collection using the ASQ in order to use these data to evaluate and refine the iterations for the informatics infrastructure.
STAGE I, Part 3: We expanded the functionality of the informatics infrastructure by testing its ability to incorporate live (ongoing) longitudinal data collected from multiple forms and data sources obtained during the STAGE II study. The addition of these data allowed the COMET Steering Committee to create use cases with a greater diversity of data content. The STAGE II data were used to evaluate and refine the iterations for the expanded informatics infrastructure.
STAGE I, Part 4: Part 4 was designed to expand the collection of data beyond individual research studies, tapping into University-wide systems (e.g., Stride) to link longitudinal data collected during research studies to longitudinal data collected during clinical visits. Only de-identified data were shared with the network, and only the local site held the codebook that translated the Global Identifier (ID) to the Participant ID. All Health Insurance Portability and Accountability Act (HIPAA) regulations were considered.
STAGE II: This stage was comprised of the multicenter, randomized, parallel group, comparative effectiveness trial to compare positive airway pressure (PAP) vs. oral appliance (OA) therapy in improving hypertension and abnormalities in cardiovascular function in overweight/obese patients with obstructive sleep apnea (OSA). Data collected during the STAGE II study were incorporated in Part 3 of the STAGE I study. This comparative effectiveness trial was conducted at 4 clinical centers, and the data collected during this trial were used to test the electronic network informatics infrastructure. The primary aim of the Stage II CET was to evaluate and compare the effect of positive airway pressure and oral appliance therapy on 24-hour blood pressure and vascular structure and function associated with obstructive sleep apnea in a primarily female, overweight/obese hypertensive population.
STAGE III: This stage was comprised of completion of data analysis and preparation of the electronic network informatics infrastructure for deployment beyond the four Clinical Centers to interested Clinical and Translational Science Awards (CTSA) institutions. We also explored expanding the ontologies beyond a sleep-related ontology to other medical ontologies, and the use of federated database methodology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive Airway Pressure | Active comparator | Device: Positive Airway Pressure (PAP)Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA). |
| Oral Appliance | Active comparator | Device: Oral Appliance (OA)Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years.
- BMI > = 25.0 kg/m^2.
- A diagnosis of obstructive sleep apnea based upon medical history and apnea- hypopnea index > = 10.0 or oxygen desaturation index (ODI; ≥4%) ≥ 10.0 on Diagnostic Polysomnogram.
- Report a history of hypertension (or need for treatment for hypertension) which is currently untreated OR taking medication for the treatment of hypertension.
- Stable medication regimen for 2 months prior to the Baseline Testing Visit. As-needed medications such as those used for allergy, cold, or minor pain symptoms may be used at the discretion of the Clinical Center physician.
Key exclusion criteria (20 listed)
- Cardiovascular disease which, in the judgment of the investigator, if observed during standard clinical practice would lead the treating physician to make every effort to treat the patient's sleep apnea with positive airway pressure, rather than alternative treatments.
- Clinically significant acute or chronic disease that is not well controlled or could affect ability to complete or comply with study procedures, in the opinion of the Clinical Center physician.
- Respiratory disease requiring supplemental oxygen or medication. Individuals with asthma may be included at the discretion of the Clinical Center physician if disease is well controlled and medications are stable for 2 months.
- History of (within 12 months prior to enrollment), or current diagnosis of, Axis I or Axis II psychiatric disorder (other than obstructive sleep apnea) that in the opinion of the Clinical Center physician would affect ability to complete or comply with study procedures (e.g., schizophrenia and other psychotic disorders).
- History of (within 3 months prior to enrollment), or current diagnosis of narcolepsy, idiopathic hypersomnia, restless legs syndrome, rapid eye movement (REM) behavior disorder, persistent situational insomnia, or sleep-related breathing disorders other than obstructive 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 |
|---|---|---|
| Positive Airway Pressure (PAP)Also: Auto-titrating PAP (APAP), Continuous PAP (CPAP)Participants randomized to the Positive Airway Pressure treatment group received adequate Positive Airway Pressure (PAP) pressure therapy by a PAP titration study and used the device for 6 months. | Device | Positive Airway Pressure |
| Oral Appliance (OA)Also: Mandibular Advancement DeviceParticipants randomized to the Oral Appliance treatment group received a dental evaluation to determine the optimal setting for the Oral Appliance (OA), and used the appliance for 6 months. | Device | Oral Appliance |
Primary outcome
Nocturnal Mean Arterial Blood Pressure (NMAP) at 2 Months
Time frame: 2 months
Mean arterial blood pressure during the sleep period as recorded by 24-hour ambulatory blood pressure monitoring after approximately 2 months of treatment
5 secondary outcomes
Nocturnal Mean Arterial Blood Pressure (NMAP) at 6 Months
Time frame: 6 months
Ratio of Nocturnal Mean Arterial Pressure (NMAP) to Daytime Mean Arterial Pressure at 2 Months
Time frame: 2 months
Ratio of NMAP to Daytime Mean Arterial Pressure at 6 Months
Time frame: 6 months
Mean Absolute Flow-Mediated Vasodilatation of the Brachial Artery by Vascular Ultrasound
Time frame: 6 months
Mean Relative Flow-Mediated Vasodilatation of the Brachial Artery by Vascular Ultrasound
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8464434Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. doi: 10.1056/NEJM199304293281704.
- Background: PubMed 25848590Nichols DA, DeSalvo S, Miller RA, Jonsson D, Griffin KS, Hyde PR, Walsh JK, Kushida CA. The COMET Sleep Research Platform. EGEMS (Wash DC). 2014 Nov 24;2(1):1059. doi: 10.13063/2327-9214.1059. eCollection 2014.
- Individual participant dataSharing planned: No
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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.
Clete A Kushida, MD, PhD study director
Stanford University
Allan Pack, MD principal investigator
Center for Sleep, University of Pennsylvania School of Medicine
Susan Redline, MD principal investigator
Harvard Brigham and Women's Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Airway Pressure (PAP) and Oral Appliance (OA) in people with Sleep Apnea, Obstructive, run by Stanford University at 4 sites 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 5 inclusion and 20 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 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Yes. Results are posted in the registry (first posted 17 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Nocturnal Mean Arterial Blood Pressure (NMAP) at 2 Months (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01461473, which also lists 2 linked publications.
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 17 May 2017.