Hypertension and Sleep Disordered Breathing in Pediatrics
Recruitment status was Recruiting
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | October 6, 2009 | ||||||||
| Last Updated Date | May 11, 2010 | ||||||||
| Start Date ICMJE | October 2008 | ||||||||
| Estimated Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT00990899 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Hypertension and Sleep Disordered Breathing in Pediatrics | ||||||||
| Official Title ICMJE | Hypertension and Sleep Disordered Breathing in Pediatrics | ||||||||
| 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. |
||||||||
| 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 Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Time Perspective: Cross-Sectional | ||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | children aged 10 to 17 years who have been diagnosed with primary hypertension |
||||||||
| Condition ICMJE |
|
||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 50 | ||||||||
| Estimated Completion Date | October 2010 | ||||||||
| Estimated Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 10 Years to 17 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00990899 | ||||||||
| Other Study ID Numbers ICMJE | 08025 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Pirzada, Melodi, MD, Winthrop-University Hospital | ||||||||
| Study Sponsor ICMJE | Winthrop University Hospital | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | Winthrop University Hospital | ||||||||
| Verification Date | May 2010 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||