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

NCT ID: NCT00131547

Last Updated: 2008-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2007-08-31

Brief Summary

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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

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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.

Conditions

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Obstructive Sleep Apnea

Keywords

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Obesity Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Usual Clinical Care

Group Type NO_INTERVENTION

No interventions assigned to this group

2

Behavioral (e.g., Counseling)

Group Type EXPERIMENTAL

Dietary Counseling

Intervention Type BEHAVIORAL

Dietary Counseling, use of a food diary and pedometer

Interventions

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Dietary Counseling

Dietary Counseling, use of a food diary and pedometer

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ontario Lung Association

OTHER

Sponsor Role collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

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Lawson Health Research Institute

Principal Investigators

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Kathleen Ferguson, MD

Role: PRINCIPAL_INVESTIGATOR

Western University, Canada

Locations

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London Health Sciences Centre

London, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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10596

Identifier Type: -

Identifier Source: secondary_id

R-04-264

Identifier Type: -

Identifier Source: org_study_id