HypertensionADOSANCT01803815
Evaluation of Antihypertensive Drugs in OSA Patients
An observational study of Hypertension and Obstructive Sleep Apnea, run by Universidade Nova de Lisboa at 1 site in Portugal.
Trial summary
This prospective cohort study aimed to assess the phenotypic characteristics of OSA patients and their pattern of antihypertensive drugs consumption. The investigators also aimed to investigate a hypothetical association between ongoing anti-hypertensive regimen and Blood pressure control rates in these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Obstructive Sleep Apnea
- How many people
- 369 participants
- Where
- 1 sitePortugal
- Study dates
- Apr 2010to Apr 2013
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients, male and women, aged above 18 years, that attended a first visit at CHLN Hospital Sleep Unit, located in Lisbon, were enrolled.
Who may be able to join
- aged above 18 years, that attended a first visit at CHLN Hospital Sleep Unit were enrolled
Who cannot join
- severe psychiatric disease or inability to understand the information required for an informed consent.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Universidade Nova de Lisboa - Faculdade de Ciências Médicas
Lisbon, 1169-056
About this study
Official title: Evaluation of Antihypertensive Drugs in Patients With Obstructive Sleep Apnea
This prospective cohort study aimed to assess the phenotypic characteristics of OSA patients and their pattern of antihypertensive drugs consumption. The investigators also aimed to investigate a hypothetical association between ongoing anti-hypertensive regimen and Blood pressure control rates in these patients. Additionally, the investigators were also interested in trying to understand if the control of OSA may be influenced by the use of different classes of anti-hypertensive drugs.
- Conditions
- Hypertension, Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, hypertension, antihypertensive drugs
- Medical subject headings
- Hypertension, Sleep Apnea, Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with uncontrolled BP before CPAP (Continuous Positive Airway Pressure) adaptation.
Measured: patients will be followed up for an expected average time of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2013 (estimated)
- Study startApr 2010
- Primary completionFeb 2013
- Study completionApr 2013
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 369 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Nova de Lisboa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucilia N Diogo, PharmD, MSc, Principal investigator, Universidade Nova de Lisboa - CEDOCPaula Pinto, PhD, MD, Study chair, CHLNCristina Bárbara, PhD, MD, Study chair, CHLNEmilia C Monteiro, PhD, MD, Study director, Universidade Nova de LisboaAna L Papoila, PhD, Study director, Universidade Nova de Lisboa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01803815
- Sponsor's protocol ID
- NOVA - CEDOC/FCT
- Acronym
- ADOSA
- Status last verified
- Oct 2014
- First submitted
- 27 Feb 2013
- Last updated
- 3 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Antihypertensive Drugs in Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT01803815
- Acronym / sponsor ID
- ADOSA / NOVA - CEDOC/FCT
- Conditions
- Hypertension, Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, hypertension, antihypertensive drugs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 369 participants (actual)
- Lead sponsor
- Universidade Nova de LisboaUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 4 Mar 2013 (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.
This prospective cohort study aimed to assess the phenotypic characteristics of OSA patients and their pattern of antihypertensive drugs consumption. The investigators also aimed to investigate a hypothetical association between ongoing anti-hypertensive regimen and Blood pressure control rates in these patients. Additionally, the investigators were also interested in trying to understand if the control of OSA may be influenced by the use of different classes of anti-hypertensive drugs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients, male and women, aged above 18 years, that attended a first visit at CHLN Hospital Sleep Unit, located in Lisbon, were enrolled.
Key inclusion criteria (1 listed)
- aged above 18 years, that attended a first visit at CHLN Hospital Sleep Unit were enrolled
Key exclusion criteria (1 listed)
- severe psychiatric disease or inability to understand the information required for an informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with uncontrolled BP before CPAP (Continuous Positive Airway Pressure) adaptation.
Time frame: patients will be followed up for an expected average time of 2 months
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 3 Nov 2014.
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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.
Lucilia N Diogo, PharmD, MSc principal investigator
Universidade Nova de Lisboa - CEDOC
Paula Pinto, PhD, MD study chair
CHLN
Cristina Bárbara, PhD, MD study chair
CHLN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Obstructive Sleep Apnea, run by Universidade Nova de Lisboa at 1 site in Portugal.
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 1 inclusion and 1 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 3 Nov 2014. 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 Portugal. 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 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.
What does the primary outcome measure?
Number of participants with uncontrolled BP before CPAP (Continuous Positive Airway Pressure) adaptation. (time frame: patients will be followed up for an expected average time of 2 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 3 Nov 2014.