- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00854334
Co-existent Obstructive Sleep Apnea (OSA) and Obesity: Finding Non-exercise Activity Thermogenesis (NEAT) Targets for Intervention
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.
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.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Ontario
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Ottawa, Ontario, Kanada, K1H 8L1
- Childrens Hospital of Eastern Ontario
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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)
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
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1.
Children with both obesity and obstructive sleep apnea
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|
2
Children without the presence of both obesity and obstructive sleep apnea
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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NEAT (kcal/day)
Tidsram: 10 day period
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10 day period
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Physical activity behavior (minutes of moderate-vigorous physical activity as directly measured by accelerometry), appetite regulating hormone profile and self-report appetite assessment.
Tidsram: 10 day period
|
10 day period
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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Neat-OSA-001
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