Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000475145
Ethics application status
Approved
Date submitted
19/03/2019
Date registered
22/03/2019
Date last updated
3/04/2019
Date data sharing statement initially provided
22/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison between positional therapy and continuous positive airway pressure therapy for positional obstructive sleep apnoea..
Scientific title
Prospective crossover trial of Positional and Continuous positive airway pressure Therapy for the treatment of mild-to-moderate positional obstructive sleep apnoea.
Secondary ID [1] 297748 0
Nil
Universal Trial Number (UTN)
U1111-1230-3289
Trial acronym
PaCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Positional obstructive sleep apnoea 312079 0
Condition category
Condition code
Respiratory 310639 310639 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Positional Therapy (NightShift)
In the positional therapy arm, patients will wear a NightShift during sleep at home for a period of 8 weeks. The NightShift device is a small position monitoring device that is worn around the neck. The device vibrates when the wearer lays in the supine position and slowly increases in intensity until the wearer changes to a non-supine position.
Adherence will be measured through the data downloaded from the NightShift device post-treatment (8 weeks). There is no washout period between treatments.
Intervention code [1] 313985 0
Treatment: Devices
Comparator / control treatment
Continuous Positive Airway Pressure (CPAP) Therapy
Patients will be asked to use CPAP therapy during sleep for a period of 8 weeks. CPAP will deliver a continuous level of positive airway pressure via a mask interface to maintain a patent airway. The CPAP settings and accessories (mask interface etc.) will be individually selected for each patient. Adherence will be measured through the data download from the CPAP device post-treatment (8 weeks).
Control group
Active

Outcomes
Primary outcome [1] 319488 0
Sleepiness as assessed by the Epworth Sleepiness Scale
Timepoint [1] 319488 0
Baseline, 8 weeks after commencing each therapy.
Secondary outcome [1] 368407 0
Patient-specified therapy preference via study-specific questionnaire.
Timepoint [1] 368407 0
At end of the trial
Secondary outcome [2] 368408 0
Adherence with therapy as assessed by download of device showing proportion of nights used by the patient
Timepoint [2] 368408 0
8 weeks after commencing each therapy.
Secondary outcome [3] 368409 0
Quality of Life as assessed by the Functional Outcomes of Sleep Questionnaire.
Timepoint [3] 368409 0
Baseline, 8 weeks after commencing each therapy.
Secondary outcome [4] 368410 0
Depression, Anxiety, Stress Scale (DASS-21)
Timepoint [4] 368410 0
Baseline, 8 weeks after commencing each therapy.
Secondary outcome [5] 368411 0
Composite outcome of the following Neurocognitive tests: (PVT, Tower of London, Go/No-Go, Match to Sample, Corsi test, Wisconsin Card-sorting test)
Timepoint [5] 368411 0
Baseline, 8 weeks after commencing each therapy.
Secondary outcome [6] 368539 0
Quality of Life as assessed by the Short Form 36 item Quality of Life questionnaire.
Timepoint [6] 368539 0
Baseline, 8 weeks after commencing each therapy.

Eligibility
Key inclusion criteria
Supine predominant positional obstructive sleep apnoea (pOSA) as defined by a total AHI >5 with a supine-to-non-supine AHI ratio >=2 on diagnostic PSG
Mild-to-moderate (>=5 AHI <30) severity pOSA
Symptomatic as defined by Epworth Sleepiness Score (ESS) >10
English-speaking adult patients
Able to perform neurocognitive tests
Able to provide informed consent.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Evidence of significant hypoxia (>=5% total sleep time <90% SpO2) on PSG
Clinically significant co-morbidity (including history of head injury, stroke or neuro-/psychiatric disorder)
Use of centrally-acting medications
Heavy alcohol consumption (>40g/day)
Pregnancy
Current shift worker;
Previous use of CPAP
Very severe symptoms which in the opinion of the treating physician requires urgent treatment with CPAP

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 is concealed via the holder of a centralized allocation schedule. The holder has no role in determining eligibility of the subjects.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization table created by the Randomizer.org program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All analyses will be conducted on an intention to treat basis and conducted with the CONSORT guidelines in mind. For the primary outcome, linear mixed effects models will be used to examine the change in sleepiness (ESS) over each treatment period. Tests of homoscedasticity and normality will be carried out to ensure model validity. Available literature suggests that the minimum clinically important difference (MCIS) in ESS is 2. We have powered to show non-inferiority. The null hypothesis is that the difference in mean ESS change between positional therapy and CPAP therapy is >=2 ESS units. Thus, based on previous clinic data and assuming a power of 80% and an alpha of 0.05 we determined that a sample size of approximately 21 patients in a crossover design is needed. Allowing for 30% attrition we will recruit 30 patients.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/04/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 13439 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 26044 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 302271 0
Hospital
Name [1] 302271 0
Princess Alexandra Hospital Study Education and Research Trust Fund
Country [1] 302271 0
Australia
Primary sponsor type
Individual
Name
Dr Mal Wilson
Address
Department of Respiratory & Sleep Medicine
Level 2F, Building 1
Princess Alexandra Hospital
Woolloongabba Qld 4102
Country
Australia
Secondary sponsor category [1] 302142 0
Individual
Name [1] 302142 0
Brett Duce
Address [1] 302142 0
Department of Respiratory & Sleep Medicine
Level 2F, Building 1
Princess Alexandra Hospital
Woolloongabba Qld 4102
Country [1] 302142 0
Australia
Secondary sponsor category [2] 302145 0
Individual
Name [2] 302145 0
Dr Claire Ellender
Address [2] 302145 0
Department of Respiratory & Sleep Medicine
Level 2F, Building 1
Princess Alexandra Hospital
Woolloongabba Qld 4102
Country [2] 302145 0
Australia
Secondary sponsor category [3] 302146 0
Individual
Name [3] 302146 0
A/Prof Craig Hukins
Address [3] 302146 0
Department of Respiratory & Sleep Medicine
Level 2F, Building 1
Princess Alexandra Hospital
Woolloongabba Qld 4102
Country [3] 302146 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302948 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 302948 0
Contracts Review Officer – Metro South Research Governance
Centres for Health Research
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba Qld 4102
Email. [email protected] Ph. (07) 3443 8050
Ethics committee country [1] 302948 0
Australia
Date submitted for ethics approval [1] 302948 0
05/02/2019
Approval date [1] 302948 0
20/02/2019
Ethics approval number [1] 302948 0
HREC

Summary
Brief summary
Obstructive sleep apnoea syndrome (OSAS) is a chronic disorder characterised by recurrent episodes of complete or partial upper airway obstruction during sleep contributing to repetitive arousals and subsequent symptoms of non-restorative sleep. In a subset of patients with OSA, obstructive events occur much more frequently during supine sleep. In such patients, considered to have positional OSA (pOSA), vibrotactile positional therapy has been shown to restrict supine sleep thereby reducing the severity of OSA, improving sleep architecture and depression scores. These devices can also be used to accurately monitor adherence and other treatment outcomes. This study will undertake a prospective crossover trial of positional and CPAP therapy in eligible patients (see Inclusion and Exclusion Criteria) with mild-to-moderate positional OSA. In a prospective, randomized crossover trial, patients with pOSA will undergo an 8 week trial of both positional therapy (NightShift) and CPAP. The primary end-point for comparison will be change in subjective sleepiness, as measured by the Epworth Sleepiness Scale (ESS).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91942 0
Dr Mal Wilson
Address 91942 0
Department of Respiratory & Sleep Medicine
Level 2F, Building 1
Princess Alexandra Hospital
Woolloongabba Qld 4102
Country 91942 0
Australia
Phone 91942 0
+61 7 3176 2698
Fax 91942 0
Email 91942 0
[email protected]
Contact person for public queries
Name 91943 0
Dr Mal Wilson
Address 91943 0
Department of Respiratory & Sleep Medicine
Level 2F, Building 1
Princess Alexandra Hospital
Woolloongabba Qld 4102
Country 91943 0
Australia
Phone 91943 0
+61 7 3176 2698
Fax 91943 0
Email 91943 0
[email protected]
Contact person for scientific queries
Name 91944 0
Dr Mal Wilson
Address 91944 0
Department of Respiratory & Sleep Medicine
Level 2F, Building 1
Princess Alexandra Hospital
Woolloongabba Qld 4102
Country 91944 0
Australia
Phone 91944 0
+61 7 3176 2698
Fax 91944 0
Email 91944 0
[email protected]

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?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1660Ethical approval    377221-(Uploaded-19-03-2019-13-27-28)-Study-related document.pdf
1662Study protocol    377221-(Uploaded-19-03-2019-13-29-41)-Study-related document.docx
1663Informed consent form    377221-(Uploaded-19-03-2019-13-30-06)-Study-related document.docx


Updated to:
Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.