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

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Dietary Counseling
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Obesity, Obstructive Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • London Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

1

2

Arm Description

Usual Clinical Care

Behavioral (e.g., Counseling)

Outcomes

Primary Outcome Measures

Post treatment weight (kg)

Secondary Outcome Measures

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

Full Information

First Posted
August 17, 2005
Last Updated
October 15, 2008
Sponsor
Lawson Health Research Institute
Collaborators
Ontario Lung Association
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1. Study Identification

Unique Protocol Identification Number
NCT00131547
Brief Title
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

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Lawson Health Research Institute
Collaborators
Ontario Lung Association

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Obesity, Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
Usual Clinical Care
Arm Title
2
Arm Type
Experimental
Arm Description
Behavioral (e.g., Counseling)
Intervention Type
Behavioral
Intervention Name(s)
Dietary Counseling
Intervention Description
Dietary Counseling, use of a food diary and pedometer
Primary Outcome Measure Information:
Title
Post treatment weight (kg)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in snoring (Visual analogue scale)
Time Frame
6 months
Title
Quality of life (FOSQ)
Time Frame
6 months
Title
Excessive daytime sleepiness (ESS)
Time Frame
6 months
Title
Waist-hip ratio (WHR)
Time Frame
6 months
Title
Blood pressure
Time Frame
6 months
Title
Lipid and glucose levels
Time Frame
6 months
Title
Sleep fragmentation
Time Frame
6 months
Title
Oxygen saturation
Time Frame
6 months
Title
Post treatment AHI
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Ferguson, MD
Organizational Affiliation
Western University, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada

12. IPD Sharing Statement

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

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