Obstructive Sleep Apnea
Conditions
Keywords
Obesity, Obstructive Sleep Apnea
Brief summary
The purpose of the study is to determine if weight loss interventions aimed at lifestyle modification (dietary education, food diary pedometer) result in weight loss in patients with mild-moderate obstructive sleep apnea (OSA) when compared to usual patient care. The secondary purpose of the study is to determine if the amount of weight loss achieved in a 6 month period results in improvements in snoring and other symptoms and in the frequency of apnea on overnight monitoring.
Detailed description
The purpose of the study is to determine if weight loss interventions aimed at lifestyle modification (dietary education, food diary pedometer) result in weight loss in patients with mild-moderate obstructive sleep apnea (OSA) when compared to usual patient care. The secondary purpose of the study is to determine if the amount of weight loss achieved in a 6 month period results in improvements in snoring and other symptoms and in the frequency of apnea on overnight monitoring. Primary Objective * To determine if weight loss interventions aimed at lifestyle modification (dietary education, food diary pedometer) result in weight loss in patients with mild-moderate OSA when compared to usual care. * To determine if the amount of weight loss achieved in a 6 month period result in improvements in objective measures of sleep disordered breathing (AHI). Secondary Objective * To determine if the weight loss achieved in 6 months result in improvements in OSA symptoms (e.g., snoring, sleepiness) and quality of life. * To determine if metabolic parameters (e.g., lipids, glucose) improve. * To determine if there is improvement in sleep structure and oxygenation during sleep.
Interventions
BEHAVIORALDietary Counseling
Dietary Counseling, use of a food diary and pedometer
Sponsors
Ontario Lung Association
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who have undergone a sleep study at the London Health Sciences Centre or St. Thomas Elgin General Hospital Sleep Laboratory and who are newly diagnosed with obstructive sleep apnea * Patients with an age over 18 years * Patients who have an apnea-hypopnea index (AHI) of 5-40 per hour (mild-to-moderate OSA) * Patients who have an elevated body mass index (BMI) of 28 to 39 kg/m2 * Patients who have an Epworth Sleepiness Scale score ≤11
Exclusion criteria
Patients will not be recruited: * if they are on weight loss medications * if they have seen a registered dietician in the preceding 6 months for dietary counseling * if they have attended a weight loss program in the last 6 months * if they have a history of a car accident related to sleepiness or report sleepiness when driving * if they work in a safety critical occupation and require treatment for work reasons * if they have serious or unstable cardiac co-morbidity * if they are unable or unwilling to provide informed consent * if they are pregnant * if they are unwilling to return for follow-up visits
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post treatment weight (kg) | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life (FOSQ) | 6 months |
| Excessive daytime sleepiness (ESS) | 6 months |
| Waist-hip ratio (WHR) | 6 months |
| Blood pressure | 6 months |
| Change in snoring (Visual analogue scale) | 6 months |
| Sleep fragmentation | 6 months |
| Oxygen saturation | 6 months |
| Post treatment AHI | 6 months |
| Lipid and glucose levels | 6 months |
Countries
Canada
Outcome results
None listed