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Randomized Study of a Simple Weight Loss Program for Obese Patients With Obstructive Sleep Apnea
This study has been completed.
Study NCT00131547   Information provided by Lawson Health Research Institute
First Received: August 17, 2005   Last Updated: October 15, 2008   History of Changes

August 17, 2005
October 15, 2008
September 2004
August 2007   (final data collection date for primary outcome measure)
Post treatment weight (kg) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Post treatment weight (kg)
  • Post treatment apnea-hypopnea index (AHI)
Complete list of historical versions of study NCT00131547 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Change in snoring (Visual analogue scale)
  • Quality of life
  • Excessive daytime sleepiness
  • Body mass index (BMI)
  • Waist-hip ratio (WHR)
  • Blood pressure
  • Neck size
  • Lipid and glucose levels
  • Sleep fragmentation
  • Oxygen saturation
 
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.

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.
 
Interventional
Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Obstructive Sleep Apnea
Behavioral: Dietary Counseling
  • No Intervention: Usual Clinical Care
  • Experimental: Behavioral (e.g., Counseling)
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
56
August 2007
August 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00131547
Dr. Kathleen Ferguson, Lawson Health Research Institute
R-04-264, 10596
Lawson Health Research Institute
Ontario Lung Association
Principal Investigator: Kathleen Ferguson, MD University of Western Ontario, Canada
Lawson Health Research Institute
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP