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

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

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Behavioral: Dietary Counseling

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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 4G5
      • London Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Post treatment weight (kg)	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Blood pressure	6 months
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
Lipid and glucose levels	6 months
Sleep fragmentation	6 months
Oxygen saturation	6 months
Post treatment AHI	6 months

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Collaborators: Ontario Lung Association
• Investigators: Principal Investigator: Kathleen Ferguson, MD, Western University, Canada

Study record dates

Study Major Dates

• Study Start: September 1, 2004
• Primary Completion (Actual): August 1, 2007
• Study Completion (Actual): August 1, 2007

Study Registration Dates

• First Submitted: August 17, 2005
• First Submitted That Met QC Criteria: August 17, 2005
• First Posted (Estimate): August 18, 2005

Study Record Updates

• Last Update Posted (Estimate): October 16, 2008
• Last Update Submitted That Met QC Criteria: October 15, 2008
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Keywords: Obesity; Obstructive Sleep Apnea
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Body Weight; Signs and Symptoms, Respiratory; Body Weight Changes; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Weight Loss
• Other Study ID Numbers: R-04-264; 10596 (Other Identifier: CTEP)