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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00131547
• Other study ID #: R-04-264
• Secondary ID: 10596
• Status: Completed
• Phase: N/A
• First received: August 17, 2005
• Last updated: October 15, 2008
• Start date: September 2004
• Est. completion date: August 2007

Study information

• Verified date: October 2008
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Behavioral:
• Dietary Counseling
Dietary Counseling, use of a food diary and pedometer

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Ontario Lung Association

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post treatment weight (kg)		6 months	No
Secondary	Change in snoring (Visual analogue scale)		6 months	No
Secondary	Quality of life (FOSQ)		6 months	No
Secondary	Excessive daytime sleepiness (ESS)		6 months	No
Secondary	Waist-hip ratio (WHR)		6 months	No
Secondary	Blood pressure		6 months	No
Secondary	Lipid and glucose levels		6 months	No
Secondary	Sleep fragmentation		6 months	No
Secondary	Oxygen saturation		6 months	No
Secondary	Post treatment AHI		6 months	No