A Research Study for Children About Heart Changes and Obstructive Sleep Apnea (OSA)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01837459
First received: April 8, 2013
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

In this research study the investigators want to learn more about the risk of developing blood vessel and heart disease from night-time sleep apnea. Sleep apnea is a condition that results from blocking of the throat during sleep. This study examines changes in blood pressure, blood vessel stiffness, heart size and levels of specific substances in the blood which may cause heart disease.

This study is for children ages 5 to 13 years. The study involves 3 visits over 18 months. The first and last visits include an overnight sleep study (polysomnography or PSG). All the visits will include:

  • body measurements to measure growth and how weight is distributed,
  • resting blood pressure measurements,
  • heart measurements (electrocardiogram and ultrasounds of the heart and blood vessels),
  • 36 hour home ambulatory blood pressure measurements,
  • blood tests to look at things like fats, cholesterol, inflammatory factors,
  • questionnaires

Optional parts of the study include DNA and for children 8 years and older, testing and questionnaires to learn more about how sleep relates to learning, memory and behavior issues.


Condition
Pediatric Obstructive Sleep Apnea

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vascular Function in Children With Obstructive Sleep Apnea

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Comparison across groups of change in levels of C-reactive protein and cytokines [ Time Frame: Baseline, 9 months, 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison across groups of changes in carotid and aortic compliance and stiffness as measured in changes in pulse waves, and carotid intima media thickness (mm) [ Time Frame: Baseline, 9 months, 18 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Serum, plasma, tissue


Estimated Enrollment: 260
Study Start Date: November 2006
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Obese-Normal
Obese with Apnea Hypopnea index (AHI) <1
Obese-SDB
Obese and with AHI>1
Lean-Normal
Non-obese with AHI<1
Lean-SDB
Non-obese with AHI>1

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   5 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Children 5-13 years recruited from the community, otolaryngology and sleep disorder clinics

Criteria

Inclusion Criteria:

  • Normal controls will be enrolled from children who have a signed informed consent and who have completed the initial polysomnography; whose history does not reveal any symptoms of obstructive breathing during sleep; and who have a polysomnogram that is considered normal.
  • SDB groups will be enrolled from children who have a signed informed consent and who have completed the initial polysomnography with OI>1; whose history includes snoring, hypertrophied tonsils or hypertrophied adenoids. Subjects will be assigned to a study group based on results of the overnight polysomnogram.

Exclusion Criteria:

Exclusion criteria:

  • Children with positive history of snoring without evidence of AHI> 1 and who do not follow through with tonsillectomy or adenoidectomy surgery.
  • Children with chronic pulmonary conditions including asthma (children with mild, intermittent asthma will be included and are defined as use of rescue inhaler < 1/wk unless treatment for exercise induced asthma).
  • Children with cardiac disease
  • Children with neuromuscular disorders
  • Children with developmental delay such as Down syndrome
  • Children with chronic renal disease such as chronic pyelonephritis or glomerulonephritis
  • Children with endocrinological disorders or who are on chronic steroid therapy including inhaled steroids.
  • Children using medications which influence the autonomic nervous system such as adrenergic and cholinergic drugs, alpha and beta blockers, and drugs with parasympatholytic action.
  • Children with any acute or chronic inflammatory condition.
  • Children with BMI Z score that exceeds 2.9 for age and gender.
  • Children who do not complete the first 36 hour AMBP study with a 70% success rate of BP readings.
  • Children with a history of chronic or recurrent tonsillitis (by parent or physician report) defined as 6 episodes of tonsillitis / year for a period of one year; 5 episodes of tonsillitis / year for 2 years; 4 episodes of tonsillitis / year for 3 years.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01837459

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Raouf Amin, MD Children's Hospital Medical Center, Cincinnati
  More Information

No publications provided

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01837459     History of Changes
Other Study ID Numbers: CIN001VF, R01HL080670-01A2
Study First Received: April 8, 2013
Last Updated: December 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Obstructive Sleep Apnea
Sleep Disordered Breathing
Vascular function
Arterial stiffness
Polysomnography
Cytokines

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on April 17, 2014