Randomized Study of a Simple Weight Loss Program for Obese Patients With Obstructive Sleep Apnea
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|ClinicalTrials.gov Identifier: NCT00131547|
Recruitment Status : Completed
First Posted : August 18, 2005
Last Update Posted : October 16, 2008
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea||Behavioral: Dietary Counseling||Not Applicable|
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.
- 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).
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Pilot Study of a Simple Weight Loss Program for Obese Patients With Mild to Moderate Obstructive Sleep Apnea|
|Study Start Date :||September 2004|
|Actual Primary Completion Date :||August 2007|
|Actual Study Completion Date :||August 2007|
No Intervention: 1
Usual Clinical Care
Behavioral (e.g., Counseling)
Behavioral: Dietary Counseling
Dietary Counseling, use of a food diary and pedometer
- Post treatment weight (kg) [ Time Frame: 6 months ]
- Change in snoring (Visual analogue scale) [ Time Frame: 6 months ]
- Quality of life (FOSQ) [ Time Frame: 6 months ]
- Excessive daytime sleepiness (ESS) [ Time Frame: 6 months ]
- Waist-hip ratio (WHR) [ Time Frame: 6 months ]
- Blood pressure [ Time Frame: 6 months ]
- Lipid and glucose levels [ Time Frame: 6 months ]
- Sleep fragmentation [ Time Frame: 6 months ]
- Oxygen saturation [ Time Frame: 6 months ]
- Post treatment AHI [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00131547
|London Health Sciences Centre|
|London, Ontario, Canada, N6A 4G5|
|Principal Investigator:||Kathleen Ferguson, MD||University of Western Ontario, Canada|