NCT00854334

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 3, 2009

Completed
1.5 years until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 9, 2018

Status Verified

March 1, 2018

Enrollment Period

2 years

First QC Date

March 2, 2009

Last Update Submit

March 7, 2018

Conditions

Keywords

SleepOverweightPhysical activityAppetiteNEAT

Outcome Measures

Primary Outcomes (1)

  • NEAT (kcal/day)

    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.

    10 day period

Study Arms (2)

1.

Children with both obesity and obstructive sleep apnea

2

Children without the presence of both obesity and obstructive sleep apnea

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability 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

You may qualify if:

  • age 10-17 years
  • coming for polysomnography at the Children's Hospital of Eastern Ontario

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Childrens Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine

MeSH Terms

Conditions

Pediatric ObesityOverweightMotor Activity

Condition Hierarchy (Ancestors)

ObesityOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDIV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Katz, Sherri Lynne, M.D.

Study Record Dates

First Submitted

March 2, 2009

First Posted

March 3, 2009

Study Start

September 1, 2010

Primary Completion

September 1, 2012

Study Completion

December 1, 2012

Last Updated

March 9, 2018

Record last verified: 2018-03

Locations