HypertensionNCT00990899
Hypertension and Sleep Disordered Breathing in Pediatrics
An observational study of Hypertension and Obstructive Sleep Apnea, run by NYU Langone Health at 1 site in United States.
Trial summary
The primary objective is to determine the prevalence of sleep disordered breathing in children with primary hypertension or pre hypertension. The secondary objectives are to determine any association factors for children with primary hypertension or prehypertension to have sleep disordered breathing be it gender, age… Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Hypertension, Obstructive Sleep Apnea
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Jul 2011
- 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: children aged 10 to 17 years who have been diagnosed with primary hypertension
Who may be able to join
- aged 10 to 17 years old diagnosed with primary hypertension
Who cannot join
- refused to participate in the study
- children to secondary hypertension
- previously diagnosed with sleep disordered breathing
Trial locations and contacts
1 site in 1 country.
United States1 site
Winthrop University Hospital
Mineola, New York, 11501
About this study
The primary objective is to determine the prevalence of sleep disordered breathing in children with primary hypertension or pre hypertension. The secondary objectives are to determine any association factors for children with primary hypertension or prehypertension to have sleep disordered breathing be it gender, age, body mass index (BMI), family history (hx) or ethnic group.
Read the detailed description
This is an exploratory, cross sectional study involving identification of the children of the age between 10 years and 17 years diagnosed with primary hypertension who have not been previously diagnosed and or treated for sleep disordered breathing with the revised pediatric sleep questionaire (PSQ) for sleep disordered breathing. The subjects that have shown interest will be mailed the informed consent/assent form to tbe reviewed. The consent/assent form will be handed to the child and all their questions and concerns will be answered in a comprehensible manner.
- Conditions
- Hypertension, Obstructive Sleep Apnea
- Keywords
- hypertension, obstructive sleep apnea, pediatrics
- Medical subject headings
- Hypertension, Sleep Apnea, Obstructive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2009 (estimated)
- Study startOct 2008
- Primary completionJul 2011
- Study completionJul 2011
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.
- More trials run by NYU Langone HealthThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melodi Pirzada, MD, Principal investigator, Winthrop University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00990899
- Sponsor's protocol ID
- 08025
- Status last verified
- Feb 2019
- First submitted
- 6 Oct 2009
- Last updated
- 6 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypertension and Sleep Disordered Breathing in Pediatrics
- ClinicalTrials.gov ID
- NCT00990899
- Acronym / sponsor ID
- 08025
- Conditions
- Hypertension, Obstructive Sleep Apnea
- Keywords
- hypertension, obstructive sleep apnea, pediatrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 7 Oct 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 primary objective is to determine the prevalence of sleep disordered breathing in children with primary hypertension or pre hypertension. The secondary objectives are to determine any association factors for children with primary hypertension or prehypertension to have sleep disordered breathing be it gender, age, body mass index (BMI), family history (hx) or ethnic group.
Detailed description
This is an exploratory, cross sectional study involving identification of the children of the age between 10 years and 17 years diagnosed with primary hypertension who have not been previously diagnosed and or treated for sleep disordered breathing with the revised pediatric sleep questionaire (PSQ) for sleep disordered breathing. The subjects that have shown interest will be mailed the informed consent/assent form to tbe reviewed. The consent/assent form will be handed to the child and all their questions and concerns will be answered in a comprehensible manner.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children aged 10 to 17 years who have been diagnosed with primary hypertension
Key inclusion criteria (1 listed)
- aged 10 to 17 years old diagnosed with primary hypertension
Key exclusion criteria (3 listed)
- refused to participate in the study
- children to secondary hypertension
- previously diagnosed with sleep disordered breathing
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
Not reported in the source record.
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 6 Feb 2019.
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.
Melodi Pirzada, MD principal investigator
Winthrop University Hospital
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 NYU Langone Health 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 1 inclusion and 3 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 6 Feb 2019. 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 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.
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 6 Feb 2019.