Co-existent Obstructive Sleep Apnea (OSA) and Obesity: Finding Non-exercise Activity Thermogenesis (NEAT) Targets for Intervention

Childhood Obesity Clinical Trial

Official title:

Co-existent OSA and Obesity: Finding NEAT Targets for Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00854334
• Other study ID #: Neat-OSA-001
• Status: Completed
• Phase: N/A
• First received: March 2, 2009
• Last updated: March 7, 2018
• Start date: September 2010
• Est. completion date: December 2012

Study information

• Verified date: March 2018
• Source: Katz, Sherri Lynne, M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Rationale: Obesity is an increasing childhood epidemic in Canada. Obstructive sleep apnea (OSA) is a complication of obesity which causes cardiovascular disease, reduced quality of life, and premature death. While the complex interactions between obesity and OSA are not entirely clear, we hypothesize that these conditions may compound each other by:

1. decreasing physical activity and total energy expenditure by reducing both non-exercise physical pursuits (NEAT- non-exercise activity thermogenesis) and purposeful physical activity.

2. alterations in the secretion of appetite-controlling hormones, which may lead to increases in energy intake.

Objective: To determine whether the presence of both obesity and OSA in children is associated with a decrease in physical activity and alterations in appetite-regulating hormones greater than those seen in either condition alone or compared to controls.

Methods: Comparison of children 10-17 years with obesity and OSA, obesity alone, OSA alone and neither condition, for the following outcomes: (1) NEAT (kcal/day) (2) Physical activity behavior, appetite regulating hormone profile and self-report appetite assessment.

Unique Aspects: This study combines expertise in sleep medicine, exercise physiology and obesity. Conclusions from this study will better characterize this high-risk clinical population so that innovative strategies targeting improvements in lifestyle behaviors can be developed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

Inclusion Criteria:

• age 10-17 years

• coming for polysomnography at the Children's Hospital of Eastern Ontario

Exclusion Criteria:

• children receiving treatment for OSA with CPAP (continuous positive airway pressure) or bi-level therapy

• craniofacial abnormalities

• genetic syndromes

• neuromuscular disease

• tracheostomy

• medications that may affect appetite or energy balance (systemic corticosteroids)

Related Conditions & MeSH terms

• Childhood Obesity
• Childhood Obstructive Sleep Apnea
• Obesity
• Pediatric Obesity
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Canada	Childrens Hospital of Eastern Ontario	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Katz, Sherri Lynne, M.D.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NEAT (kcal/day)		10 day period
Secondary	Physical activity behavior (minutes of moderate-vigorous physical activity as directly measured by accelerometry), appetite regulating hormone profile and self-report appetite assessment.		10 day period