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Trial registered on ANZCTR


Registration number
ACTRN12616000203459
Ethics application status
Approved
Date submitted
23/01/2016
Date registered
16/02/2016
Date last updated
21/01/2020
Date data sharing statement initially provided
21/01/2020
Date results information initially provided
21/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The Sleeping Well Trial: enhancing the effectiveness of continuous positive airway pressure (CPAP) treatment with a weight management program for overweight adults
Scientific title
Increasing the effectiveness of treatment with continuous positive airways pressure (CPAP) using a weight-management program in overweight adults with sleep apnoea : the Sleeping Well Trial
Secondary ID [1] 288385 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Apnoea 297389 0
Obesity 297390 0
Condition category
Condition code
Respiratory 297579 297579 0 0
Sleep apnoea
Diet and Nutrition 297580 297580 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To address aim 1) Primary outcome (weight) as measured during each month during the control and intervention periods of the stepped wedge design will be compared between periods. The main effect of the intervention will be examined using a multilevel, mixed effects, linear mixed model analysis approach. Fixed effects will be included in this model for “time” and “intervention”, while a random effect will be included for the effect of “participant”.
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). This analysis will treat "lifestyle intervention commencement month" as a continuous variable and examine both a linear and quadratic relationship with the outcome.

CPAP treatment: All CPAP implementation will be provided centrally for all patients by Air Liquide Healthcare. Patients will undergo mask fitting and education regarding sleep apnoea and CPAP use by staff at Air Liquide. Patients will initially be commenced on Autotitrating CPAP using a Resmed S9 CPAP machine. After 1 week of treatment, patients will be switched to fixed pressure CPAP based on the 95th centile pressure determined during the autotitration week. Routine equipment troubleshooting will be provided by Air Liquide, in conjunction with the patient’s treating physician. Patients will undergo routine CPAP care co-ordinated by their physician. All decisions regarding any treatment changes will be made by the treating physician. Participants are required to use their CPAP devices regularly for 12 months period (beginning from consent date).

Lifestyle Intervention: All participants will be exposed to the 6-month weight management program. The wait list time for starting treatment will differ with subjects randomised to wait 1,2,3,4,5 or 6 months before they commence. The Intervention is a dietitian delivered face to face intervention comprising of a 1 hour initial appointment followed up by monthly 30 minute consultations. Dietary energy will be reduced using a tailored approach with a 12 week active weight loss phase followed by a 12 week transfer to weight maintenance phase the duration of each phase will be dependant on how much weight each participant has to lose and their success, which is monitored monthly by body weight.
The use of an App to extend the reach of the face to face sessions will be utilised. The App allows the participant to connect virtually with their dietitian to report hurdles, feelings or mood that may affect their progress towards their goals. The dietitian can communicate via a pre-defined pathway of text messages which are sent to the participant to motivate them to continue to meet their 'small steps'.

Activity is encouraged with 3 x 30 minutes per week of light/ moderate physical activity.

Compliance is measured for activity via a wrist worn monitor (Fitbit) which records minute by minute activity on a website which the participant consents to the research team being able to access. Dietary recording is used to monitor compliance with meal plans and agreed nutrient goals. Compliance with CPAP treatment is recorded individually and is inbuilt into each CPAP machine, as minutes per day that it is used.
Intervention code [1] 293689 0
Treatment: Devices
Intervention code [2] 293690 0
Lifestyle
Intervention code [3] 293862 0
Behaviour
Comparator / control treatment
All participants will have active treatment by CPAP machine for their sleep apnoea through the study.
Control group
Active

Outcomes
Primary outcome [1] 297126 0
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.
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).
Timepoint [1] 297126 0
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.
Secondary outcome [1] 320095 0
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)
Timepoint [1] 320095 0
Immediately prior to commencing the 6 months of lifestyle intervention and on completion of the lifestyle intervention.

Eligibility
Key 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).
Minimum age
19 Years
Maximum age
68 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation known only to study statistician and stored in co-investigators office in opaque sealed envelopes and will be made available only after recruitment of an individual.
Recruiters, outcome assessors and physicians providing care are blinded to group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Conducted by the Study statistician using sequence generated in Excel Randbetween procedure.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Design: Randomised controlled trial utilizing 6 different delay periods between commencement of CPAP and commencement of the lifestyle intervention. There will be groups with 1, 2, 3, 4, 5, and 6 months delay.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size calculations:
Our proposed research design has 6 separate “steps” (delay periods) not including the baseline assessment. If we were to recruit 7 participants into each group, it would provide 82% power to detect a main effect of the intervention of 1.5 Kg difference in weight between intervention and control assessments. This assumes a standard deviation of 3.09 Kg (based on previously collected local data), uses a conservative ICC of 0.01, and treats each individual participant as its own cluster (as this is the unit of randomisation). Collecting 10 participants per group will provide coverage within the trial for potential drop-outs and missing data while maintaining adequate trial power.
Statistical analysis plan
The main effect of the intervention will be examined using a multilevel, mixed effects, linear mixed model analysis approach. Fixed effects will be included in this model for “time” and “intervention”, while a random effect will be included for the effect of “participant”.
We will examine whether there is a difference in the rate of change in primary outcome between control and intervention periods using a “time-by-intervention” interaction effect.
The effect of delay in provision of the lifestyle intervention will be investigated by examining an “intervention-by-delay period” interaction effect. Both a linear effect of the period of delay and a quadratic effect will be investigated. Statistical adjustment will be made for other relevant variables in each of these analyses.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 9821 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 9822 0
Box Hill Hospital - Box Hill
Recruitment postcode(s) [1] 18602 0
3168 - Clayton
Recruitment postcode(s) [2] 18603 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 292741 0
University
Name [1] 292741 0
Monash University
Address [1] 292741 0
Department of Food, Nutrition and Dietetics
School of Clinical Sciences
Monash University
1/264 Ferntree Gully Road
Notting Hill 3168
Victoria
Country [1] 292741 0
Australia
Funding source category [2] 292855 0
Commercial sector/Industry
Name [2] 292855 0
Air Liquide
Address [2] 292855 0
5 / 476 Gardeners Road
Alexandria
NSW 2015

Provision of CPAP devices and support to all participants in this trial
Country [2] 292855 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Be Active Sleep Eat Facility
Monash University
1/264 Ferntree Gully Road
Notting Hill 3168
Victoria
Country
Australia
Secondary sponsor category [1] 291471 0
Commercial sector/Industry
Name [1] 291471 0
Air Liquide Healthcare
Address [1] 291471 0
5 / 476 Gardeners Road
Alexandria
NSW 2015
Country [1] 291471 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294225 0
Monash Health Human Ethics Commitee
Ethics committee address [1] 294225 0
Research Support Services
Monash Health
Monash Medical Centre
Clayton Road
Clayton 3168
Victoria
Ethics committee country [1] 294225 0
Australia
Date submitted for ethics approval [1] 294225 0
28/07/2015
Approval date [1] 294225 0
20/10/2015
Ethics approval number [1] 294225 0
HREC/15/MonH/93 Ref 15357A

Summary
Brief summary
This study has been designed to elucidate when is the optimal time to introduce weight management to newly diagnosed patients with OSA who are about to commence on standard care which is overnight CPAP. We have designed this trial to have a step wedge element so that each person will be exposed to the intervention over a 12 month period. To address aim 1) Primary outcome (weight) as measured during each month during the control and intervention periods of the stepped wedge design will be compared between periods. The main effect of the intervention will be examined using a multilevel, mixed effects, linear mixed model analysis approach. Fixed effects will be included in this model for “time” and “intervention”, while a random effect will be included for the effect of “participant”.
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). This analysis will treat "lifestyle intervention commencement month" as a continuous variable and examine both a linear and quadratic relationship with the outcome.

This design has certain advantages over standard randomized controlled trials which include enabling every participant to be exposed to the intervention and that the impact of time is assessed. This design consists of an initial period, where no one is exposed to the intervention. Eventually, at regular intervals (the “steps”) one cluster (one group) will be randomised to cross from the control to the intervention under evaluation.


Trial website
Trial related presentations / publications
Public notes
Attachments [1] 730 730 0 0

Contacts
Principal investigator
Name 62958 0
Prof Helen Truby
Address 62958 0
Department of Food, Nutrition and Dietetics
Monash University
Be Active Sleep Eat facility
1/264 Ferntree Gully Road
Notting Hill
Vic 3168
Country 62958 0
Australia
Phone 62958 0
+61 3 9902 4261
Fax 62958 0
Email 62958 0
helen.truby@monash.edu
Contact person for public queries
Name 62959 0
Prof Helen Truby
Address 62959 0
Department of Nutrition and Dietetics
Monash University
Be Active Sleep Eat facility
1/264 Ferntree Gully Road
Notting Hill
Vic 3168
Country 62959 0
Australia
Phone 62959 0
+61 3 9902 4261
Fax 62959 0
Email 62959 0
helen.truby@monash.edu
Contact person for scientific queries
Name 62960 0
Prof Helen Truby
Address 62960 0
Department of Food, Nutrition and Dietetics
Monash University
Be Active Sleep Eat facility
1/264 Ferntree Gully Road
Notting Hill
Vic 3168
Country 62960 0
Australia
Phone 62960 0
+613 9902 4261
Fax 62960 0
Email 62960 0
helen.truby@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 6508 0
Study protocol
Citation [1] 6508 0
Truby, H, Edwards, B. A, O'Driscoll, D. M, Young, A, Ghazi, L, Bristow, C, Roem, K, Bonham, M. P, Murgia, C, Day, K, Haines, T. P, Hamilton, G. S. 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 Nutrition Dietetics 2018 DOI 10.1111/1747-0080.12435
Link [1] 6508 0
Email [1] 6508 0
Other [1] 6508 0
Attachment [1] 6508 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary