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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Katz, Sherri Lynne, M.D..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Katz, Sherri Lynne, M.D.
ClinicalTrials.gov Identifier:
NCT00854334
First received: March 2, 2009
Last updated: July 18, 2011
Last verified: July 2011
  Purpose

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.


Condition
Childhood Obesity
Childhood Obstructive Sleep Apnea

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Co-existent OSA and Obesity: Finding NEAT Targets for Intervention

Resource links provided by NLM:


Further study details as provided by Katz, Sherri Lynne, M.D.:

Primary Outcome Measures:
  • NEAT (kcal/day) [ Time Frame: 10 day period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

urine


Estimated Enrollment: 40
Study Start Date: September 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1.
Children with both obesity and obstructive sleep apnea
2
Children without the presence of both obesity and obstructive sleep apnea

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Subjects will be recruited from those scheduled to undergo polysomnography in the sleep laboratory at the Children's Hospital of Eastern Ontario

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00854334

Contacts
Contact: Lynda Hoey, RN, CCRP 613-737-7600 ext 4109 lhoey@cheo.on.ca

Locations
Canada, Ontario
Childrens Hospital of Eastern Ontario Recruiting
Ottawa, Ontario, Canada, K1H 8L1
Principal Investigator: Sherri Katz         
Principal Investigator: Rachel Colley         
Sponsors and Collaborators
Katz, Sherri Lynne, M.D.
  More Information

No publications provided

Responsible Party: Dr. Sherri Katz, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier: NCT00854334     History of Changes
Other Study ID Numbers: Neat-OSA-001
Study First Received: March 2, 2009
Last Updated: July 18, 2011
Health Authority: Canada: Health Canada

Keywords provided by Katz, Sherri Lynne, M.D.:
Sleep
Overweight
Physical activity
Appetite
NEAT

Additional relevant MeSH terms:
Apnea
Obesity
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on April 17, 2014