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