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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Lawson Health Research Institute
Ontario Thoracic Society
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 Counselling
Behavioral: use of a pedometer
Behavioral: use of a food diary

MedlinePlus related topics:   Obesity    Sleep Apnea    Snoring    Weight Control   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:   A Randomized Controlled Pilot Study of a Simple Weight Loss Program for Obese Patients With Mild to Moderate Obstructive Sleep Apnea

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Post treatment apnea-hypopnea index (AHI)
  • Post treatment weight (kg)

Secondary Outcome Measures:
  • 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

Estimated Enrollment:   50
Study Start Date:   September 2004
Estimated Study Completion Date:   July 2007

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.

  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 Thoracic Society

Investigators
Principal Investigator:     Kathleen Ferguson, MD     University of Western Ontario, Canada    
  More Information


Study ID Numbers:   R-04-264
First Received:   August 17, 2005
Last Updated:   April 12, 2007
ClinicalTrials.gov Identifier:   NCT00131547
Health Authority:   Canada: Health Canada

Keywords provided by Lawson Health Research Institute:
Obesity  
Obstructive Sleep Apnea  

Study placed in the following topic categories:
Obesity
Sleep Apnea Syndromes
Apnea
Sleep Apnea, Obstructive
Respiration Disorders
Sleep Disorders
Dyssomnias
Sleep Disorders, Intrinsic
Body Weight
Signs and Symptoms
Respiratory Tract Diseases
Weight Loss
Body Weight Changes
Signs and Symptoms, Respiratory

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on October 03, 2008




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