NCT00990899

Brief 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, body mass index (BMI), family history (hx) or ethnic group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 7, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

February 6, 2019

Status Verified

February 1, 2019

Enrollment Period

2.7 years

First QC Date

October 6, 2009

Last Update Submit

February 4, 2019

Conditions

HypertensionObstructive Sleep Apnea

Keywords

hypertensionobstructive sleep apneapediatrics

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

children aged 10 to 17 years who have been diagnosed with primary hypertension

You may qualify if:

  • aged 10 to 17 years old diagnosed with primary hypertension

You may not qualify if:

  • refused to participate in the study
  • children to secondary hypertension
  • previously diagnosed with sleep disordered breathing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

MeSH Terms

Conditions

HypertensionSleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesSleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Melodi Pirzada, MD

    Winthrop University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2009

First Posted

October 7, 2009

Study Start

October 1, 2008

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

February 6, 2019

Record last verified: 2019-02

Locations

US(1)