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

Sponsor

Lawson Health Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00131547

Collaborator

Ontario Lung Association (Other)

Enrollment

Location

Arms

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea	Behavioral: Dietary Counseling	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2004

Actual Primary Completion Date :

Aug 1, 2007

Actual Study Completion Date :

Aug 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 1 Usual Clinical Care
Experimental: 2 Behavioral (e.g., Counseling)	Behavioral: Dietary Counseling Dietary Counseling, use of a food diary and pedometer

Arm

Intervention/Treatment

No Intervention: 1

Usual Clinical Care

Experimental: 2

Behavioral (e.g., Counseling)

Behavioral: Dietary Counseling

Dietary Counseling, use of a food diary and pedometer

Outcome Measures

Primary Outcome Measures

Post treatment weight (kg) [6 months]

Secondary Outcome Measures

Change in snoring (Visual analogue scale) [6 months]
Quality of life (FOSQ) [6 months]
Excessive daytime sleepiness (ESS) [6 months]
Waist-hip ratio (WHR) [6 months]
Blood pressure [6 months]
Lipid and glucose levels [6 months]
Sleep fragmentation [6 months]
Oxygen saturation [6 months]
Post treatment AHI [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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