Randomised Study of a Simple Weight Loss Program for Obese Patients With Obstructive Sleep Apnoea

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 apnoea (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 apnoea on overnight monitoring.

Official Title

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

Conditions

• Obstructive Sleep Aponoea

Study Type

Interventional

Study Design

Treatment, Randomised, Open Label, Active Control, Parallel Assignment, Efficacy Study.

Further Details

Primary Outcome Measures:

• Post treatment apnoea-hypopnoea index (AHI)
• Post treatment weight (kg)

Secondary Outcome Measures:

• Change in snoring (Visual analogue scale)
• Quality of life
• Excessive daytime sleepiness
• Body mass index (BMI)
• Waist-hip ratio (WHR)
• Blood pressure
• Neck size
• Lipid and glucose levels
• Sleep fragmentation
• Oxygen saturation

Study Start

September 2004

Eligibility & Criteria

• Ages Eligible for Study: 18 years and older
• Genders Eligible for Study: Both
• Accepts 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 apnoea
• Patients with an age over 18 years
• Patients who have an apnoea-hypopnoea 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
• Have seen a registered dietitian in the preceding 6 months for dietary counselling
• Have attended a weight loss program in the last 6 months
• Have a history of a car accident related to sleepiness or report sleepiness when driving
• Work in a safety critical occupation and require treatment for work reasons
• Have serious or unstable cardiac co-morbidity
• Are unable or unwilling to provide informed consent
• Are pregnant
• Are unwilling to return for follow-up visits

Total Enrolment

50

Contact Details

London Health Sciences Centre
London, Ontario
Canada, N6A 4G5