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 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.

Condition	Intervention
Obstructive Sleep Apnea	Behavior: Dietary Counselling  Behavior: use of a pedometer  Behavior: use of a food diary

Further Study Details: 

Primary Outcomes: Post treatment apnea-hypopnea index (AHI); Post treatment weight (kg)
Secondary Outcomes: 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
Expected Total Enrollment:  50

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  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 of AHI of 5-40 per hour (mild-to-moderate OSA)
• Patients who have an elevated body mass index (BMI) 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00131547

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

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

Study chairs or principal investigators

Kathleen Ferguson, MD,  Principal Investigator,  University of Western Ontario, Canada   

Study ID Numbers:  10596
Last Updated:  August 17, 2005
Record first received:  August 17, 2005
ClinicalTrials.gov Identifier:  NCT00131547
Health Authority: Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-08-23