Sleeping Well Trial: Increasing the effectiveness of treatment with continuous positive airway pressure using a weight management program in overweight adults with obstructive sleep apnoea—A stepped wedge randomised trial protocol

May 26, 2018Nutrition & dietetics : the journal of the Dietitians Association of Australia

Improving sleep apnea treatment in overweight adults by adding a weight loss program to continuous airway pressure therapy: a stepped wedge trial plan

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Abstract

The Sleeping Well Trial investigates the effect of a 6-month lifestyle intervention on individuals with moderate-severe obstructive sleep apnoea (OSA) undergoing CPAP treatment.

The trial examines whether the timing of a weight loss intervention influences weight changes in patients with OSA.
Only 50% of patients prescribed CPAP continue long-term, highlighting a need for improved adherence strategies.
Adherence to CPAP therapy may lead to increased weight gain, potentially worsening OSA.
The study utilizes smart phone technology to support lifestyle interventions and enhance adherence.

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BACKGROUND: The majority of adults diagnosed with obstructive sleep apnoea (OSA) are overweight or obese. Continuous positive airway pressure (CPAP) is the most common effective therapy for OSA. However, adherence declines over time with only 50% of patients prescribed CPAP continuing to use it long term. Furthermore, a recent prospective analysis indicated that those more adherent with CPAP therapy have enhanced weight gain trajectories which in turn may negatively impact their OSA.

AIM: The Sleeping Well Trial aims to establish whether the timing of starting a lifestyle weight loss intervention impacts on weight trajectory in those with moderate-severe OSA treated at home with CPAP, while testing the potential for smart phone technology to improve adherence with lifestyle interventions.

METHODS: A stepped wedge design with randomisation of individuals from 1 to 6 months post-enrolment, with 5 months of additional prospective follow up after completion of the stepped wedge. This design will investigate the effect of the 6-month lifestyle intervention on people undergoing CPAP on body weight, body composition and health-related quality of life.

DISCUSSION: This trial tests whether the timing of supporting the patient through a weight loss intervention is important in obtaining the maximum benefit of a lifestyle change and CPAP usage, and identify how best to support patients through this critical period.

TRIAL REGISTRATION: The protocol (v1) is registered prospectively with the International Clinical Trials Registry (CTR) ACTRN12616000203459 (public access). Any amendments to protocol will be documented via the CTR. Recruitment commenced in March 2016 with data collection scheduled to finish by May 2018.

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Sleeping Well Trial: Increasing the effectiveness of treatment with continuous positive airway pressure using a weight management program in overweight adults with obstructive sleep apnoea—A stepped wedge randomised trial protocol

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