Obstructive Sleep ApneaNCT01837459
A Research Study for Children About Heart Changes and Obstructive Sleep Apnea (OSA)
An observational study of Obstructive Sleep Apnea, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- How many people
- 231 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children 5-13 years recruited from the community, otolaryngology and sleep disorder clinics
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Vascular Function in Children With Obstructive Sleep Apnea
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:
Read more
- 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.
Read the detailed description
This study is designed primarily to investigate the changes in blood vessels compliance and stiffness in children ages 5 to 13 years with the syndrome of obstructive breathing during sleep. It is designed to examine the relationship of the severity of the syndrome to vascular functions and to specific inflammatory mediators related to early stages of arterial stiffness and their effect on cardiovascular end-points, namely twenty-hour ambulatory blood pressure and left ventricular mass. The study will also examine the relationship between plasma and tonsillar tissue levels of inflammatory cytokines, and as well as the relationships between obstructive breathing during sleep and children's attention and problem-solving skills. Our aim is to identify vascular risk factors in childhood and to determine whether sleep disordered breathing in children represents an independent risk factor for cardiovascular disease and neurodevelopmental deficits which if left inadequately identified could track into adult years
- Hypothesis that increased levels of inflammatory cytokines will correlate with severity of the OSA disorder.
- Hypothesis that severity of the OSA disorder will correlate with measures of increased arterial wall stiffness, which in turn will lead to an increase in pulse pressure and left ventricular mass.
This study will examine the vascular function in children, both lean and obese, with the syndrome of obstructive breathing during sleep which encompasses children with varying degrees of sleep disordered breathing (SDB). Children included in the SDB groups will have OSA above 1 obstructive episode per hour of sleep. The standard of care for a child with symptoms of obstructive breathing during sleep in otolaryngology practices is to undergo a tonsillectomy and or adenoidectomy (T\&A). Children with SDB and who are scheduled to have T\&A will be followed for 18 months and compared to children without SDB. To discern the effect of obesity on vascular function from the effects of sleep disordered breathing (SDB), the study will consist of four groups. Two groups, one lean and one obese, will have SDB and two groups, one lean and one obese, will be normal controls. Efforts will be made to match subjects across all groups. There is the potential that all groups will not contain the same number due to differences in incidence of OSA in relation to weight.
There are 3 visits over approximately 18 months. The first visit will function as a qualifying visit based on the Obstructive Index from the polysomnography (OI>1 for SDB group and OI<1 with no snoring for the control group). Visits are approximately 9 months apart with the first and last visit including overnight polysomnography (PSG). Tonsillar tissue specimens will be obtained from a subset of SDB subjects who are scheduled for T\&A.
Data captured will include:
- Blood will be measured for high-sensitivity C reactive protein (hsCRP), serum amyloid A, cytokine panel, fasting lipoprotein analysis, complete blood count (CBC), glucose, insulin direct renin and DNA (optional).
- Tonsillar tissue will be measured for hsCRP, serum amyloid A, cytokine panel.
- Anthropometrics including height, weight, arm and finger circumferences, neck circumference, waist to hip ratio, and arm lengths.
- Left ventricular structure and vascular stiffness measurements include echocardiogram, carotid ultrasound, and radial tonometry.
- Resting blood pressure measurements include a continuous beat to beat BP recording obtained by a Portapres monitor with ECG and respiration monitoring done throughout sleep during the PSG and 30 minutes while awake in the morning.
- Activity and home ambulatory blood pressure (AMBP)measurements will be continuously monitored (every 30 minutes) using an automated oscillometric BP monitor over a 36 hour period simultaneously with actigraphy.
- Questionnaires about sleep and QOL.
- A subset of subjects aged 8 and older can participate in a neurobehavioral component that includes a formal assessment of attention and problem-solving.
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive Sleep Apnea, Sleep Disordered Breathing, Vascular function, Arterial stiffness, Polysomnography, Cytokines
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison across groups of change in levels of C-reactive protein and cytokines
Measured: 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)
Measured: Baseline, 9 months, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2013 (estimated)
- Study startNov 2006
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Raouf Amin, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01837459
- Sponsor's protocol ID
- CIN001VF
- Other IDs
- R01HL080670-01A2
- Status last verified
- Apr 2016
- First submitted
- 8 Apr 2013
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Analysis is in progress and may take up to an additional year due to complexity of data.
Publications
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.
PubMed 40170220Domany 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.
PubMed 33220319
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Function in Children With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT01837459
- Acronym / sponsor ID
- CIN001VF
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive Sleep Apnea, Sleep Disordered Breathing, Vascular function, Arterial stiffness, Polysomnography, Cytokines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Nov 2006
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 23 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is designed primarily to investigate the changes in blood vessels compliance and stiffness in children ages 5 to 13 years with the syndrome of obstructive breathing during sleep. It is designed to examine the relationship of the severity of the syndrome to vascular functions and to specific inflammatory mediators related to early stages of arterial stiffness and their effect on cardiovascular end-points, namely twenty-hour ambulatory blood pressure and left ventricular mass. The study will also examine the relationship between plasma and tonsillar tissue levels of inflammatory cytokines, and as well as the relationships between obstructive breathing during sleep and children's attention and problem-solving skills. Our aim is to identify vascular risk factors in childhood and to determine whether sleep disordered breathing in children represents an independent risk factor for cardiovascular disease and neurodevelopmental deficits which if left inadequately identified could track into adult years
- Hypothesis that increased levels of inflammatory cytokines will correlate with severity of the OSA disorder.
- Hypothesis that severity of the OSA disorder will correlate with measures of increased arterial wall stiffness, which in turn will lead to an increase in pulse pressure and left ventricular mass.
This study will examine the vascular function in children, both lean and obese, with the syndrome of obstructive breathing during sleep which encompasses children with varying degrees of sleep disordered breathing (SDB). Children included in the SDB groups will have OSA above 1 obstructive episode per hour of sleep. The standard of care for a child with symptoms of obstructive breathing during sleep in otolaryngology practices is to undergo a tonsillectomy and or adenoidectomy (T\&A). Children with SDB and who are scheduled to have T\&A will be followed for 18 months and compared to children without SDB. To discern the effect of obesity on vascular function from the effects of sleep disordered breathing (SDB), the study will consist of four groups. Two groups, one lean and one obese, will have SDB and two groups, one lean and one obese, will be normal controls. Efforts will be made to match subjects across all groups. There is the potential that all groups will not contain the same number due to differences in incidence of OSA in relation to weight.
There are 3 visits over approximately 18 months. The first visit will function as a qualifying visit based on the Obstructive Index from the polysomnography (OI>1 for SDB group and OI<1 with no snoring for the control group). Visits are approximately 9 months apart with the first and last visit including overnight polysomnography (PSG). Tonsillar tissue specimens will be obtained from a subset of SDB subjects who are scheduled for T\&A.
Data captured will include:
- Blood will be measured for high-sensitivity C reactive protein (hsCRP), serum amyloid A, cytokine panel, fasting lipoprotein analysis, complete blood count (CBC), glucose, insulin direct renin and DNA (optional).
- Tonsillar tissue will be measured for hsCRP, serum amyloid A, cytokine panel.
- Anthropometrics including height, weight, arm and finger circumferences, neck circumference, waist to hip ratio, and arm lengths.
- Left ventricular structure and vascular stiffness measurements include echocardiogram, carotid ultrasound, and radial tonometry.
- Resting blood pressure measurements include a continuous beat to beat BP recording obtained by a Portapres monitor with ECG and respiration monitoring done throughout sleep during the PSG and 30 minutes while awake in the morning.
- Activity and home ambulatory blood pressure (AMBP)measurements will be continuously monitored (every 30 minutes) using an automated oscillometric BP monitor over a 36 hour period simultaneously with actigraphy.
- Questionnaires about sleep and QOL.
- A subset of subjects aged 8 and older can participate in a neurobehavioral component that includes a formal assessment of attention and problem-solving.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children 5-13 years recruited from the community, otolaryngology and sleep disorder clinics
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison across groups of change in levels of C-reactive protein and cytokines
Time frame: Baseline, 9 months, 18 months
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
- Derived from this study: PubMed 40170220Witter 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.
- Derived from this study: PubMed 33220319Domany 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.
- Individual participant dataSharing planned: Undecided. Analysis is in progress and may take up to an additional year due to complexity of data.
Related trials for Obstructive Sleep Apnea
Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Obstructive Sleep Apnea, Cognitive Decline
RecruitingObservational study
Prevalence, Phenotypes, Predictors and Prognostic Implication of Obstructive Sleep Apnea in Pulmonary Hypertension
Sleep Apnea, Obstructive Sleep Apnea
Recruiting
Effect of Transcutaneous Electrical Stimulation on Polysomnographic Parameters in Patients With Obstructive Sleep Apnea
Obstructive Sleep Apnea
Not yet recruiting
Physical Activity, Sleep Quality, and Respiratory Function in Obstructive Sleep Apnea
Obstructive Sleep Apnea, Sleep Quality
RecruitingPhase 4
Impact GLP-1 Agonists Following Bariatric
Morbid Obesity, Metabolic Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raouf Amin, MD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison across groups of change in levels of C-reactive protein and cytokines (time frame: Baseline, 9 months, 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01837459, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2016.