Randomized Study of a Simple Weight Loss Program for Obese Patients With Obstructive Sleep Apnea

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Controlled Pilot Study of a Simple Weight Loss Program for Obese Patients With Mild to Moderate Obstructive Sleep Apnea

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Behavioral: Dietary Counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>Usual Clinical Care | |
| Experimental: 2<br>Behavioral (e.g., Counseling) | Behavioral: Dietary Counseling<br>* Dietary Counseling, use of a food diary and pedometer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post treatment weight (kg) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Obstructive Sleep Apnea