Condition(s) treated: Obstructive Sleep Apnea

Intervention: Dietary Counselling (Behavior); use of a pedometer (Behavior); use of a food diary (Behavior)

Enrollment status: Recruiting. Expecting to enroll 50 people.

Sponsor: Lawson Health Research Institute

Principal investigator(s) or official(s):
Kathleen Ferguson, MD, Principal Investigator, Affiliation: University of Western Ontario, Canada

Overall contact:
Kathleen Ferguson, MD, Phone: 519-667-6586, Email: kathleen.ferguson@lhsc.on.ca

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.

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

Study design: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Post treatment apnea-hypopnea index (AHI); Post treatment weight (kg)

Secondary outcome: 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

Minimum eligible age: 18 Years. Eligible gender(s): Both.

Criteria:

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

Kathleen Ferguson, MD, Phone: 519-667-6586, Email: kathleen.ferguson@lhsc.on.ca

London Health Sciences Centre, London, Ontario N6A 4G5, Canada; Recruiting
Kathleen Ferguson, MD, Phone: 519-667-6586, Email: kathleen.ferguson@lhsc.on.ca
Kathleen Ferguson, MD, Principal Investigator

Start date: September 2004
End date: August 2007
Last updated: September 6, 2006