Randomized Study of a Simple Weight Loss Program for Obese Patients With Obstructive Sleep Apnea
- Conditions
- Obstructive Sleep Apnea
- Interventions
- Behavioral: Dietary Counseling
- Registration Number
- NCT00131547
- Lead Sponsor
- Lawson Health Research Institute
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
- 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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Dietary Counseling Behavioral (e.g., Counseling)
- Primary Outcome Measures
Name Time Method Post treatment weight (kg) 6 months
- Secondary Outcome Measures
Name Time Method Change in snoring (Visual analogue scale) 6 months Quality of life (FOSQ) 6 months Excessive daytime sleepiness (ESS) 6 months Waist-hip ratio (WHR) 6 months Blood pressure 6 months Lipid and glucose levels 6 months Sleep fragmentation 6 months Oxygen saturation 6 months Post treatment AHI 6 months
Trial Locations
- Locations (1)
London Health Sciences Centre
🇨🇦London, Ontario, Canada