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Completed

NCT Number: NCT00131547

Randomized Study of a Simple Weight Loss Program for Obese Patients With 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dietary Counseling

Behavioral

Dietary Counseling, use of a food diary and pedometer

Primary outcomes

  1. Post treatment weight (kg)

    Time frame: 6 months

Secondary outcomes

  1. Change in snoring (Visual analogue scale)

    Time frame: 6 months

  2. Quality of life (FOSQ)

    Time frame: 6 months

  3. Excessive daytime sleepiness (ESS)

    Time frame: 6 months

  4. Waist-hip ratio (WHR)

    Time frame: 6 months

  5. Blood pressure

    Time frame: 6 months

  6. Lipid and glucose levels

    Time frame: 6 months

  7. Sleep fragmentation

    Time frame: 6 months

  8. Oxygen saturation

    Time frame: 6 months

  9. Post treatment AHI

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Ontario Lung Association

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Aug 18, 2005
Registry last updated
Oct 16, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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