Pragmatic Obstructive Sleep Apnea Weight Loss Trial Assessing Effectiveness and Reach

Not Applicable

Active, not recruiting

• Conditions: Obesity; Sleep Apnea, Obstructive

• Registration Number: NCT05104450
• Lead Sponsor: VA Office of Research and Development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-19
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 696

Inclusion Criteria

Inclusion Criteria:<br><br> - Diagnosis of obstructive sleep apnea (OSA) on sleep study (sleep provider confirmed)<br><br> - Recent body mass index between 30.0-44.9 kg/m2 and at least one additional plausible<br> BMI in last 12 months<br><br> - Access to DVD player, computer, and/or internet<br><br> - Able to participate fully in all study protocol/procedures including informed<br> consent<br><br>Exclusion Criteria:<br><br> - Inability to speak, read, or understand English<br><br> - Recent or active weight loss interventions including use of prescription weight-loss<br> medications, participation in group or individual weight loss programs provided by<br> trained personnel, and prior bariatric surgery or plans for bariatric surgery during<br> the study period.<br><br> - Expected weight loss because of alternate explanations such as from illness<br><br> - High variability in weight due to fluctuations in volume status (e.g. ascites -<br> liver disease, chronic heart failure)<br><br> - Safety and/or adherence concerns due to severe physical or mental health issues, or<br> life expectancy <24 months<br><br> - Pregnant, lactating, or planning to become pregnant during the study period<br><br> - Participation in other intervention studies

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change in sleep-related quality of life;change in weight

Secondary Outcome Measures

Name	Time	Method
cardiovascular risk scores;PROMIS - Sleep Disturbance Survey change;PROMIS - Sleep Related Impairment Survey change;systolic blood pressure from VA medical record;treatment usage per day;apnea hypopnea index 1b criteria;longer-term change in weight;short-term change in sleep-related quality of life;longer-term change in sleep-related quality of life;Global Rating of Change;change in self-reported well-being;cardiovascular risk scores;PROMIS - Sleep Disturbance Survey change;PROMIS - Sleep Disturbance Survey change;PROMIS - Sleep Related Impairment Survey change;PROMIS - Sleep Related Impairment Survey change;systolic blood pressure from VA medical record;diastolic blood pressure from VA medical record;diastolic blood pressure from VA medical record;treatment usage per day;treatment usage per day;Global Rating of Change;Global Rating of Change;change in self-reported well-being;change in self-reported well-being;apnea hypopnea index 1a criteria