Treatment of Obstructive Sleep Apnea in Children: An Opportunity for Cardiovascular Risk Modification

NCT02403492 | Completed DMC

• 1 other identifier: 1000026523
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Obesity; Obstructive Sleep Apnea; Sleep Disorders; Cardiovascular Disease

Keywords

Children; Obesity; Cardiovascular; Sleep; Apnea; Obstructive

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Baseline, 6 Months

• To assess the efficacy of PAP therapy for OSAS in obese children on heart rate variability.

  Baseline, 6 Months

• To determine changes in blood pressure in obese children with OSAS prior to and post treatment with PAP therapy.

  Baseline, 6 Months

• To assess the efficacy of PAP therapy for OSAS on changes in insulin resistance in obese children.

  Baseline, 6 Months

• To assess the efficacy of PAP therapy for OSAS in obese children on changes in vascular structure using pulse wave velocity.

  Baseline, 6 Months

Other Outcomes (2)

• To assess the efficacy of PAP therapy for OSAS in obese children on changes in physical activity levels.

  Baseline, 6 Months

• To assess the efficacy of PAP therapy for OSAS in obese children on changes in sleep duration.

  Baseline, 6 Months

Study Arms (3)

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

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

Device: cPAP; Device: cPAP, Discontinuation

Interventions

cPAP DEVICE

All participants diagnosed with obstructive sleep apnea will be required to use cPAP for 6 months prior to the RCT component of this trial

Also known as: continuous Positive Airway Pressure

Experimental - cPAP Discontinuation; Experimental - cPAP, Continuation

cPAP, Continuation DEVICE

Participants will be randomized to continue cPAP for a 2 week period

Experimental - cPAP, Continuation

cPAP, Discontinuation DEVICE

Participants will be randomized to discontinue cPAP for a 2 week period

Experimental - cPAP Discontinuation

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Obesity, BMI \> 95th centile for age and gender
• years of age
• Informed consent and the ability to perform the tests

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Obesity; Sleep Apnea, Obstructive; Sleep Wake Disorders; Cardiovascular Diseases; Apnea

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Neurologic Manifestations; Mental Disorders; Signs and Symptoms, Respiratory

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Indra Narang, MD, FRCPCH

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Sleep Medicine, Staff Pulmonologist

Study Record Dates

• First Submitted: December 22, 2014
• First Posted: March 31, 2015
• Study Start: August 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: May 5, 2016

Record last verified: 2016-05

Locations

CA (1)