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OpenTrials
Completed

NCT Number: NCT00854334

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

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.

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Key information

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Childrens Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. NEAT (kcal/day)

    Time frame: 10 day period

Secondary outcomes

  1. Physical activity behavior (minutes of moderate-vigorous physical activity as directly measured by accelerometry), appetite regulating hormone profile and self-report appetite assessment.

    Time frame: 10 day period

Sponsors and collaborators

Lead sponsor

Katz, Sherri Lynne, M.D.

Indiv

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Mar 3, 2009
Registry last updated
Mar 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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