Randomized Study of a Simple Weight Loss Program for Obese Patients With Obstructive Sleep Apnea - Full Text View

Sponsor:	Lawson Health Research Institute
Collaborator:	Ontario Lung Association
Information provided by:	Lawson Health Research Institute
ClinicalTrials.gov Identifier:	NCT00131547

Purpose

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	Intervention
Obstructive Sleep Apnea	Behavioral: Dietary Counseling

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Obesity Sleep Apnea Snoring Weight Control

U.S. FDA Resources

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:

Post treatment weight (kg) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in snoring (Visual analogue scale) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Quality of life (FOSQ) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Excessive daytime sleepiness (ESS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Waist-hip ratio (WHR) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Lipid and glucose levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Sleep fragmentation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Oxygen saturation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Post treatment AHI [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment:	56
Study Start Date:	September 2004
Study Completion Date:	August 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

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

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00131547

Locations

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

Sponsors and Collaborators

Lawson Health Research Institute

Ontario Lung Association

Investigators

Principal Investigator:

Kathleen Ferguson, MD

University of Western Ontario, Canada

More Information

No publications provided

Responsible Party:	Dr. Kathleen Ferguson, Lawson Health Research Institute
ClinicalTrials.gov Identifier:	NCT00131547 History of Changes
Other Study ID Numbers:	R-04-264, 10596
Study First Received:	August 17, 2005
Last Updated:	October 15, 2008
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:

Obesity
Obstructive Sleep Apnea

Additional relevant MeSH terms:

Apnea
Sleep Apnea Syndromes
Weight Loss
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory

Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Body Weight Changes
Body Weight

ClinicalTrials.gov processed this record on February 09, 2012