Clinical trial NCT00131547: Randomized Study of a Simple Weight Loss Program for Obese Patients With Obstructive Sleep Apnea
Official title: A Randomized Controlled Pilot Study of a Simple Weight Loss Program for Obese Patients With Mild to Moderate Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Obesity
Obstructive Sleep Apnea
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Ontario Lung Association
First posted: 2005-08-18
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Post treatment weight (kg)
timeFrame: 6 months
Secondary outcomes:
measure: Change in snoring (Visual analogue scale)
timeFrame: 6 months
measure: Quality of life (FOSQ)
timeFrame: 6 months
measure: Excessive daytime sleepiness (ESS)
timeFrame: 6 months
measure: Waist-hip ratio (WHR)
timeFrame: 6 months
measure: Blood pressure
timeFrame: 6 months
measure: Lipid and glucose levels
timeFrame: 6 months
measure: Sleep fragmentation
timeFrame: 6 months
measure: Oxygen saturation
timeFrame: 6 months
measure: Post treatment AHI
timeFrame: 6 months
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: Western University, Canada
name: Kathleen Ferguson, MD
role: PRINCIPAL_INVESTIGATOR
References: