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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01837459
Recruitment Status : Completed
First Posted : April 23, 2013
Last Update Posted : April 14, 2016
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Brief Summary:

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 or disease
Obstructive Sleep Apnea

Show Show detailed description

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Study Type : Observational
Actual Enrollment : 231 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vascular Function in Children With Obstructive Sleep Apnea
Study Start Date : November 2006
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Obese with Apnea Hypopnea index (AHI) <1
Obese and with AHI>1
Non-obese with AHI<1
Non-obese with AHI>1

Primary Outcome Measures :
  1. Comparison across groups of change in levels of C-reactive protein and cytokines [ Time Frame: Baseline, 9 months, 18 months ]

Secondary Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples With DNA
Serum, plasma, tissue

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   5 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children 5-13 years recruited from the community, otolaryngology and sleep disorder clinics

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01837459

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United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Raouf Amin, MD Children's Hospital Medical Center, Cincinnati

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Responsible Party: Children's Hospital Medical Center, Cincinnati Identifier: NCT01837459    
Other Study ID Numbers: CIN001VF
R01HL080670-01A2 ( U.S. NIH Grant/Contract )
First Posted: April 23, 2013    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Analysis is in progress and may take up to an additional year due to complexity of data.
Keywords provided by Children's Hospital Medical Center, Cincinnati:
Obstructive Sleep Apnea
Sleep Disordered Breathing
Vascular function
Arterial stiffness
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases