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

Lawson Health Research Institute

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Behavioral: Dietary Counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT00131547

R-04-264

10596 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

1

No Intervention group

Description:

Usual Clinical Care

2

Experimental group

Description:

Behavioral (e.g., Counseling)

Treatment:

Behavioral: Dietary Counseling