The Sleeping Well Trial: enhancing the effectiveness of continuous positive airway pressure (CPAP) treatment with a weight management program for overweight adults

Not Applicable

Completed

• Conditions: Sleep Apnoea; Obesity; Respiratory - Sleep apnoea; Diet and Nutrition - Obesity

• Registration Number: ACTRN12616000203459
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-16
• Study Completion: 2018-05-09
• Last Update Posted: 3 February 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Adults aged 19-68 years who have been newly diagnosed with moderate-severe untreated OSA with AHI greater than 20 events/hr (AASM alternate criteria) (demonstrated by prior overnight polysomnography [PSG]). Participants must be overweight with a body mass index (BMI) for Caucasians between 25 and 43 kg/m2 and for those of Asian and Indian descent 23 and 43 and self report a sedentary lifestyle ((self-reported exercise less than 2 days/week and a duration of less than 45 minutes per session. Eligible participants are required to be eligible to use Fixed-Pressure Continuous Positive Airway Pressure (CPAP).

Exclusion Criteria

1. Pregnant women
2. Diagnosed with concomitant obesity hypoventilation syndrome, Diabetes mellitus type 1, severe psychiatric disorder, and drowsiness
3. Required to use VPAP or BPAP (variable/bilevel positive airway pressure)
4. Unable to exercise (e.g. due to orthopedic or musculoskeletal problems)
5. Previous surgical or current medical treatment for OSA
6. Previous bariatric surgery
7. Current use of weight loss programs and/or weight loss drugs
8. Recent angina pectoris or atrial fibrillation
9. Insufficient knowledge of English language to be able to consent
10. Unable to provide informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Both aims will use weight as the outcome measure (weight in kilograms measured on a digital scale). Weight will be measured monthly during the control and the intervention periods. Different data collection timepoints are used to address both aim 1 and 2.<br> The stepped wedge design enables many data collection points to contribute to answering aim 1.. To address aim 2 we will examine the association between lifestyle intervention commencement month and weight at 12 month follow-up (adjusted for baseline weight). [Weight will be measured monthly for all participants. We will examine the association between lifestyle intervention commencement month and weight at 12 month follow-up (adjusted for baseline weight) to answer aim 2. This analysis will treat lifestyle intervention commencement month as a continuous variable and examine both a linear and quadratic relationship with the outcome. ]<br>

Secondary Outcome Measures

Name	Time	Method
Body fat (%) and fat free mass (%) will be measured immediately prior to starting the lifestyle intervention by the reference method of dual energy xray absorptiometry and after 6 months (on completion of the lifestyle intervention) [Immediately prior to commencing the 6 months of lifestyle intervention and on completion of the lifestyle intervention.]