ObesityTREATNCT02403492
Treatment of Obstructive Sleep Apnea in Children: An Opportunity for Cardiovascular Risk Modification
A study testing cPAP, cPAP, Continuation and cPAP, Discontinuation in people with Obesity and Obstructive Sleep Apnea, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Heart disease is a major cause of ill-health and death in adults. The risk factors for heart disease, if present in children, carry over into adult life. Childhood obesity has reached epidemic proportions in Canada and is associated with many heart disease risk factors such as high blood pressure. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Obesity, Obstructive Sleep Apnea, Sleep Disorders
- What is being tested?
- cPAP, cPAP, Continuation and cPAP, Discontinuation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2013to Aug 2015
- Phase
- Interventional
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Obesity, BMI > 95th centile for age and gender
- 10-18 years of age
- Informed consent and the ability to perform the tests
- Moderate to sever OSAS (will be eligible for inclusion in the treatment group for this study)
Who cannot join
- Use of anti-hypertensive medication
- Medications known to alter glucose and insulin regulation
- Significant central sleep apnea
- Currently unwell or recent viral/bacterial infection in the previous 4 weeks
- Currently hospitalized
- Known underlying neuromuscular disorder, congenital heart disease, diagnosed ventricular disorder
Show all 10Show fewer
- Syndrome's e.g. Down (high prevalence of OSAS independent of obesity)
- Pregnancy
- Gastric bypass surgery
- Unable to have a PSG perfumed for whatever reason
Trial locations and contacts
1 site in 1 country.
About this study
Heart disease is a major cause of ill-health and death in adults. The risk factors for heart disease, if present in children, carry over into adult life. Childhood obesity has reached epidemic proportions in Canada and is associated with many heart disease risk factors such as high blood pressure. Another complication of obesity is obstructive sleep apnea. Sleep apnea is marked by snoring at night, pauses in breathing and low oxygen levels and occurs in up to 60% of obese children, but it is diagnosed in less than 20% of obese children. Importantly, sleep apnea in children, like obesity, is linked with high blood pressure and heart disease. Thus, children with sleep apnea who are obese are likely to have an increased risk for high blood pressure and heart disease. Currently, there is little knowledge of the extent of heart disease in obese children with sleep apnea.
The best treatment for both obesity and sleep apnea is weight loss. Weight loss strategies are generally not very successful and since 75% of obese children will become obese adults, urgent treatments are needed to reduce heart disease in the long-term. Treating sleep apnea in obese children may be one of the ways to reduce heart disease. Sleep apnea can be treated with continuous positive airway pressure (CPAP), which involves wearing a mask attached to a breathing machine while asleep. It is unknown how effective CPAP is in reducing heart disease in obese children.
Read more
The investigators will recruit children with sleep apnea who are obese and test for heart disease risk. The investigators will then treat these children with CPAP. After 6 months of CPAP, the investigators will repeat the tests to determine if CPAP lowers the risk for heart disease. At the end of the 6 months, those receiving CPAP will be randomized to either continue CPAP or discontinue CPAP for a 2 week period. At the end of the 2 week period the participants will repeat the tests again to determine the magnitude of the effect of CPAP.
The investigators expect that CPAP treatment for sleep apnea in obese children will reduce blood pressure and lower heart disease. These results will increase awareness of the dangers of sleep apnea in obese children, which will facilitate early diagnosis and treatment, ultimately reducing heart disease long-term.
Read the detailed description
Statement of the Problem: In Canada, child and adolescent obesity, defined as a body mass index (BMI) of >95th percentile for age and gender1 represents one of the most common conditions effecting children in Canada with an obesity rate of 10% in 12-17 year old children, which currently equates to approximately half a million obese children in Canada. Obesity is not only complicated by cardiovascular and metabolic dysfunction, such as left ventricular modeling, hypertension, glucose intolerance and dyslipidaemia, it is also associated with obstructive sleep apnea syndrome (OSAS), occurring in up to 60% of obese children.
OSAS is characterized by snoring, recurrent partial (hypopneas) or complete obstruction (apneas) of the upper airway, frequently associated with intermittent oxyhaemoglobin desaturations, sleep disruption and fragmentation. The gold standard test for diagnosing obstructive sleep apnea is a polysomnogram (PSG). Specifically, OSAS affects 1-4% of healthy children who are typically 2-8 years of age6, coinciding with adenotonsillar hypertrophy, the commonest cause of OSAS in children. Usual treatment for OSAS in children with adenotonsillar hypertrophy is an adenotonsillectomy (AT). However, there is clear evidence that not only is there a high prevalence of obstructive sleep apnea in obese children, but further, the AT is not successful for resolution of OSAS. This is, in part due to the fact that adenotonsillar hypertrophy is not the single most significant risk factor for OSAS in the obese population.
The factors implicated in the pathophysiology of OSAS in obese children include soft tissues restricting the upper airway size such as fat pads in the soft palate, lateral pharyngeal wall and at the base of the tongue. However, despite the anatomic evidence predisposing obese children to OSAS there are also alterations in functional mechanisms that lead to increased airway collapsibility predisposing these children to OSAS. Specifically, obesity is associated with significant alterations in body composition that could affect chest wall mechanics by weighting the chest wall and reducing lung compliance. Functional residual capacity is diminished to abdominal visceral fat impinging on the chest cavity. Such a reduction in functional residual capacity and compliance increases the risk for sleep disordered breathing by mechanisms of hypoventilation, atelectasis and ventilation perfusion mismatch all increasing the work of breathing and fatigue. Moreover, hypoventilation in itself may reduce upper airway motor tone. Further, ventilator responses may be altered as studies focusing on obese adults have shown that morbidly obese subjects are more susceptible to decreased ventilatory responses to both hypoxia and hypercapnia.
Given this understanding that adenotonsillectomy is not curative in obese children with obstructive sleep apnea, weight loss would be considered the treatment of choice. However, obesity intervention programs have not been wholly successful in BMI reduction in children although in overweight adults, magnitude of weight loss was related to an improvement in OSAS. Thus, the delivery of positive airway pressure (PAP) either continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP) is increasingly used as the first line of treatment for OSAS in obese children, although usually in conjunction with weight loss strategies.
Although the benefits of PAP are well established in adults, there is a paucity of available paediatric data.
As previously mentioned, obesity is a risk factor for cardiovascular and metabolic dysfunction; however, OSAS independent of obesity is further associated with cardiac remodeling and cardiovascular metabolic dysfunction. Specifically, if untreated, obstructive sleep apnea in children may lead to excessive daytime sleepiness, poor school performance, hypertension, changes in left ventricular mass and geometry, endothelial cell dysfunction, arterial stiffness, autonomic dysfunction inflammation, and the Metabolic Syndrome (MetS). Thus, OSAS in the context of obesity may independently or synergistically magnify the risk of an already compromised cardiometabolic regulation.
Several metrics will be utilized. Physical activity levels will be measured utilizing Habitual Activity Questionnaires. Insulin resistance will be measured using Fasting Glucose and Fasting Insulin Levels. Cardiovascular markers will include 24 hour blood pressure and cardiograms - left ventricular mass index. C Reactive Protein (CRP) will be utilized as the marker of inflammation.
The mechanisms linking both OSAS and obesity to cardiometabolic dysfunction is believed to be due to activity of the sympathetic nervous system (SNS) and effects of oxidative stress, exacerbating proinflammatory states. Chronic, awake sympathoactivation may promote vascular remodeling and can induce significant cardiovascular morbidity.
- Being tested
- cPAP, cPAP, Continuation, cPAP, Discontinuation
- Keywords
- Children, Obesity, Cardiovascular, Sleep, Apnea, Obstructive
- Medical subject headings
- Obesity, Sleep Apnea, Obstructive, Sleep Wake Disorders, Cardiovascular Diseases, Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cPAPDevice
Also called continuous Positive Airway Pressure
All participants diagnosed with obstructive sleep apnea will be required to use cPAP for 6 months prior to the RCT component of this trial
cPAP, ContinuationDevice
Participants will be randomized to continue cPAP for a 2 week period
cPAP, DiscontinuationDevice
Participants will be randomized to discontinue cPAP for a 2 week period
| Study group | Role | What they receive |
|---|---|---|
| Observational (No OSAS) | No intervention | Comprised of obese children are not found to have obstructive sleep apnea and do not require cPAP |
| Experimental - cPAP, Continuation | Experimental | Comprised of those obese children who are diagnosed with obstructive sleep apnea, requiring cPAP, who continue using cPAP during the 2 week RCT Receives: Device: cPAP; Device: cPAP, Continuation |
| Experimental - cPAP Discontinuation | Experimental | Comprised of those obese children who are diagnosed with obstructive sleep apnea, requiring cPAP, who discontinue using cPAP during the 2 week RCT Receives: Device: cPAP; Device: cPAP, Discontinuation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess changes in cardiovascular markers pre and post PAP therapy
To assess the efficacy of PAP therapy for OSAS in obese children on left ventricular mass index.
Measured: Baseline, 6 Months
Secondary outcomes (6)
To evaluate changes in health-related quality of life prior to and post treatment with PAP therapy for OSAS.
Measured: Baseline, 6 Months
To assess the efficacy of PAP therapy for OSAS in obese children on heart rate variability.
Measured: Baseline, 6 Months
To determine changes in blood pressure in obese children with OSAS prior to and post treatment with PAP therapy.
Measured: Baseline, 6 Months
To assess the efficacy of PAP therapy for OSAS on changes in insulin resistance in obese children.
Measured: Baseline, 6 Months
To assess the efficacy of PAP therapy for OSAS in obese children on changes in vascular structure using pulse wave velocity.
Measured: Baseline, 6 Months
To assess changes in C Reactive Protein (CRP) markers pre and post PAP therapy in obese children with OSAS.
Measured: Baseline, 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startAug 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Indra Narang, The Hospital for Sick Children
- Investigators
- Indra Narang, MD, FRCPCH, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02403492
- Sponsor's protocol ID
- 1000026523
- Acronym
- TREAT
- Status last verified
- May 2016
- First submitted
- 22 Dec 2014
- Last updated
- 5 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Obstructive Sleep Apnea in Children: An Opportunity for Cardiovascular Risk Modification
- ClinicalTrials.gov ID
- NCT02403492
- Acronym / sponsor ID
- TREAT / 1000026523
- Keywords
- Children, Obesity, Cardiovascular, Sleep, Apnea, Obstructive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 31 Mar 2015 (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.
Heart disease is a major cause of ill-health and death in adults. The risk factors for heart disease, if present in children, carry over into adult life. Childhood obesity has reached epidemic proportions in Canada and is associated with many heart disease risk factors such as high blood pressure. Another complication of obesity is obstructive sleep apnea. Sleep apnea is marked by snoring at night, pauses in breathing and low oxygen levels and occurs in up to 60% of obese children, but it is diagnosed in less than 20% of obese children. Importantly, sleep apnea in children, like obesity, is linked with high blood pressure and heart disease. Thus, children with sleep apnea who are obese are likely to have an increased risk for high blood pressure and heart disease. Currently, there is little knowledge of the extent of heart disease in obese children with sleep apnea.
The best treatment for both obesity and sleep apnea is weight loss. Weight loss strategies are generally not very successful and since 75% of obese children will become obese adults, urgent treatments are needed to reduce heart disease in the long-term. Treating sleep apnea in obese children may be one of the ways to reduce heart disease. Sleep apnea can be treated with continuous positive airway pressure (CPAP), which involves wearing a mask attached to a breathing machine while asleep. It is unknown how effective CPAP is in reducing heart disease in obese children.
The investigators will recruit children with sleep apnea who are obese and test for heart disease risk. The investigators will then treat these children with CPAP. After 6 months of CPAP, the investigators will repeat the tests to determine if CPAP lowers the risk for heart disease. At the end of the 6 months, those receiving CPAP will be randomized to either continue CPAP or discontinue CPAP for a 2 week period. At the end of the 2 week period the participants will repeat the tests again to determine the magnitude of the effect of CPAP.
The investigators expect that CPAP treatment for sleep apnea in obese children will reduce blood pressure and lower heart disease. These results will increase awareness of the dangers of sleep apnea in obese children, which will facilitate early diagnosis and treatment, ultimately reducing heart disease long-term.
Detailed description
Statement of the Problem: In Canada, child and adolescent obesity, defined as a body mass index (BMI) of >95th percentile for age and gender1 represents one of the most common conditions effecting children in Canada with an obesity rate of 10% in 12-17 year old children, which currently equates to approximately half a million obese children in Canada. Obesity is not only complicated by cardiovascular and metabolic dysfunction, such as left ventricular modeling, hypertension, glucose intolerance and dyslipidaemia, it is also associated with obstructive sleep apnea syndrome (OSAS), occurring in up to 60% of obese children.
OSAS is characterized by snoring, recurrent partial (hypopneas) or complete obstruction (apneas) of the upper airway, frequently associated with intermittent oxyhaemoglobin desaturations, sleep disruption and fragmentation. The gold standard test for diagnosing obstructive sleep apnea is a polysomnogram (PSG). Specifically, OSAS affects 1-4% of healthy children who are typically 2-8 years of age6, coinciding with adenotonsillar hypertrophy, the commonest cause of OSAS in children. Usual treatment for OSAS in children with adenotonsillar hypertrophy is an adenotonsillectomy (AT). However, there is clear evidence that not only is there a high prevalence of obstructive sleep apnea in obese children, but further, the AT is not successful for resolution of OSAS. This is, in part due to the fact that adenotonsillar hypertrophy is not the single most significant risk factor for OSAS in the obese population.
The factors implicated in the pathophysiology of OSAS in obese children include soft tissues restricting the upper airway size such as fat pads in the soft palate, lateral pharyngeal wall and at the base of the tongue. However, despite the anatomic evidence predisposing obese children to OSAS there are also alterations in functional mechanisms that lead to increased airway collapsibility predisposing these children to OSAS. Specifically, obesity is associated with significant alterations in body composition that could affect chest wall mechanics by weighting the chest wall and reducing lung compliance. Functional residual capacity is diminished to abdominal visceral fat impinging on the chest cavity. Such a reduction in functional residual capacity and compliance increases the risk for sleep disordered breathing by mechanisms of hypoventilation, atelectasis and ventilation perfusion mismatch all increasing the work of breathing and fatigue. Moreover, hypoventilation in itself may reduce upper airway motor tone. Further, ventilator responses may be altered as studies focusing on obese adults have shown that morbidly obese subjects are more susceptible to decreased ventilatory responses to both hypoxia and hypercapnia.
Given this understanding that adenotonsillectomy is not curative in obese children with obstructive sleep apnea, weight loss would be considered the treatment of choice. However, obesity intervention programs have not been wholly successful in BMI reduction in children although in overweight adults, magnitude of weight loss was related to an improvement in OSAS. Thus, the delivery of positive airway pressure (PAP) either continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP) is increasingly used as the first line of treatment for OSAS in obese children, although usually in conjunction with weight loss strategies.
Although the benefits of PAP are well established in adults, there is a paucity of available paediatric data.
As previously mentioned, obesity is a risk factor for cardiovascular and metabolic dysfunction; however, OSAS independent of obesity is further associated with cardiac remodeling and cardiovascular metabolic dysfunction. Specifically, if untreated, obstructive sleep apnea in children may lead to excessive daytime sleepiness, poor school performance, hypertension, changes in left ventricular mass and geometry, endothelial cell dysfunction, arterial stiffness, autonomic dysfunction inflammation, and the Metabolic Syndrome (MetS). Thus, OSAS in the context of obesity may independently or synergistically magnify the risk of an already compromised cardiometabolic regulation.
Several metrics will be utilized. Physical activity levels will be measured utilizing Habitual Activity Questionnaires. Insulin resistance will be measured using Fasting Glucose and Fasting Insulin Levels. Cardiovascular markers will include 24 hour blood pressure and cardiograms - left ventricular mass index. C Reactive Protein (CRP) will be utilized as the marker of inflammation.
The mechanisms linking both OSAS and obesity to cardiometabolic dysfunction is believed to be due to activity of the sympathetic nervous system (SNS) and effects of oxidative stress, exacerbating proinflammatory states. Chronic, awake sympathoactivation may promote vascular remodeling and can induce significant cardiovascular morbidity.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Observational (No OSAS) | No intervention | –Comprised of obese children are not found to have obstructive sleep apnea and do not require cPAP |
| Experimental - cPAP, Continuation | Experimental | Device: cPAP, Device: cPAP, ContinuationComprised of those obese children who are diagnosed with obstructive sleep apnea, requiring cPAP, who continue using cPAP during the 2 week RCT |
| Experimental - cPAP Discontinuation | Experimental | Device: cPAP, Device: cPAP, DiscontinuationComprised of those obese children who are diagnosed with obstructive sleep apnea, requiring cPAP, who discontinue using cPAP during the 2 week RCT |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Obesity, BMI > 95th centile for age and gender
- 10-18 years of age
- Informed consent and the ability to perform the tests
- Moderate to sever OSAS (will be eligible for inclusion in the treatment group for this study)
Key exclusion criteria (10 listed)
- Use of anti-hypertensive medication
- Medications known to alter glucose and insulin regulation
- Significant central sleep apnea
- Currently unwell or recent viral/bacterial infection in the previous 4 weeks
- Currently hospitalized
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cPAPAlso: continuous Positive Airway PressureAll participants diagnosed with obstructive sleep apnea will be required to use cPAP for 6 months prior to the RCT component of this trial | Device | Experimental - cPAP Discontinuation, Experimental - cPAP, Continuation |
| cPAP, ContinuationParticipants will be randomized to continue cPAP for a 2 week period | Device | Experimental - cPAP, Continuation |
| cPAP, DiscontinuationParticipants will be randomized to discontinue cPAP for a 2 week period | Device | Experimental - cPAP Discontinuation |
Primary outcome
To assess changes in cardiovascular markers pre and post PAP therapy
Time frame: Baseline, 6 Months
To assess the efficacy of PAP therapy for OSAS in obese children on left ventricular mass index.
6 secondary outcomes
To evaluate changes in health-related quality of life prior to and post treatment with PAP therapy for OSAS.
Time frame: Baseline, 6 Months
To assess the efficacy of PAP therapy for OSAS in obese children on heart rate variability.
Time frame: Baseline, 6 Months
To determine changes in blood pressure in obese children with OSAS prior to and post treatment with PAP therapy.
Time frame: Baseline, 6 Months
To assess the efficacy of PAP therapy for OSAS on changes in insulin resistance in obese children.
Time frame: Baseline, 6 Months
To assess the efficacy of PAP therapy for OSAS in obese children on changes in vascular structure using pulse wave velocity.
Time frame: Baseline, 6 Months
To assess changes in C Reactive Protein (CRP) markers pre and post PAP therapy in obese children with OSAS.
Time frame: Baseline, 6 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 5 May 2016.
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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.
Indra Narang, MD, FRCPCH principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cPAP, cPAP, Continuation and cPAP, Discontinuation in people with Obesity and Obstructive Sleep Apnea, run by The Hospital for Sick Children at 1 site in Canada.
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 4 inclusion and 10 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 5 May 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 Canada. 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?
To assess changes in cardiovascular markers pre and post PAP therapy (time frame: Baseline, 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 May 2016.