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

NCT01837459 | Completed

• 2 other identifiers: CIN001VFR01HL080670-01A2
• Study Type: observational
• Target: 231
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep Apnea; Sleep Disordered Breathing; Vascular function; Arterial stiffness; Polysomnography; Cytokines

Outcome Measures

Primary Outcomes (1)

• Comparison across groups of change in levels of C-reactive protein and cytokines

  Baseline, 9 months, 18 months

Secondary Outcomes (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)

  Baseline, 9 months, 18 months

Study Arms (4)

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

Eligibility Criteria

• Age: 5 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (2)

• Witter AM, Smith DF, Khan MTF, Nakamura A, Schuler CL, DiFrancesco MW, Hossain MM, Amin RS. Relationship of Circadian Blood Pressure Dysregulation With Left Ventricular Structure and Function in Children With Obstructive Sleep Apnea. J Sleep Res. 2025 Oct;34(5):e70049. doi: 10.1111/jsr.70049. Epub 2025 Apr 1.

  PMID: 40170220 DERIVED

• Domany KA, Huang G, Hossain MM, Schuler CL, Somers VK, Daniels SR, Amin R. Effect of Adenotonsillectomy on Cardiac Function in Children Age 5-13 Years With Obstructive Sleep Apnea. Am J Cardiol. 2021 Feb 15;141:120-126. doi: 10.1016/j.amjcard.2020.11.019. Epub 2020 Nov 19.

  PMID: 33220319 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma, tissue

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Raouf Amin, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2013
• First Posted: April 23, 2013
• Study Start: November 1, 2006
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 14, 2016

Record last verified: 2016-04

Locations

US (1)