Childhood ObesityNCT00854334
Co-existent Obstructive Sleep Apnea (OSA) and Obesity: Finding Non-exercise Activity Thermogenesis (NEAT) Targets for Intervention
An observational study of Childhood Obesity and Childhood Obstructive Sleep Apnea, run by Katz, Sherri Lynne, M.D. at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 10 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity, Childhood Obstructive Sleep Apnea
- How many people
- 9 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2010to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Subjects will be recruited from those scheduled to undergo polysomnography in the sleep laboratory at the Children's Hospital of Eastern Ontario
Who may be able to join
- age 10-17 years
- coming for polysomnography at the Children's Hospital of Eastern Ontario
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Co-existent OSA and Obesity: Finding 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:
- decreasing physical activity and total energy expenditure by reducing both non-exercise physical pursuits (NEAT- non-exercise activity thermogenesis) and purposeful physical activity.
- alterations in the secretion of appetite-controlling hormones, which may lead to increases in energy intake.
Read more
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.
- Keywords
- Sleep, Overweight, Physical activity, Appetite, NEAT
- Medical subject headings
- Pediatric Obesity, Overweight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1. | Children with both obesity and obstructive sleep apnea | |
| 2 | Children without the presence of both obesity and obstructive sleep apnea |
What is being measured
The primary outcome is the main question the study is designed to answer.
NEAT (kcal/day)
Measured: 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.
Measured: 10 day period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2009 (estimated)
- Study startSep 2010
- Primary completionSep 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Katz, Sherri Lynne, M.D.
- Responsible party
- Principal investigator, Dr. Sherry Lynn Katz, Children's Hospital of Eastern Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00854334
- Sponsor's protocol ID
- Neat-OSA-001
- Status last verified
- Mar 2018
- First submitted
- 2 Mar 2009
- Last updated
- 9 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-existent OSA and Obesity: Finding NEAT Targets for Intervention
- ClinicalTrials.gov ID
- NCT00854334
- Acronym / sponsor ID
- Neat-OSA-001
- Keywords
- Sleep, Overweight, Physical activity, Appetite, NEAT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Katz, Sherri Lynne, M.D.
- Study start
- Sep 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 3 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- decreasing physical activity and total energy expenditure by reducing both non-exercise physical pursuits (NEAT- non-exercise activity thermogenesis) and purposeful physical activity.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. | – | –Children with both obesity and obstructive sleep apnea |
| 2 | – | –Children without the presence of both obesity and obstructive sleep apnea |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Subjects will be recruited from those scheduled to undergo polysomnography in the sleep laboratory at the Children's Hospital of Eastern Ontario
Key inclusion criteria (2 listed)
- age 10-17 years
- coming for polysomnography at the Children's Hospital of Eastern Ontario
Key exclusion criteria (6 listed)
- children receiving treatment for OSA with CPAP (continuous positive airway pressure) or bi-level therapy
- craniofacial abnormalities
- genetic syndromes
- neuromuscular disease
- tracheostomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
NEAT (kcal/day)
Time frame: 10 day period
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Obesity and Childhood Obstructive Sleep Apnea, run by Katz, Sherri Lynne, M.D. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NEAT (kcal/day) (time frame: 10 day period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2018.