Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000699864
Ethics application status
Approved
Date submitted
27/06/2012
Date registered
29/06/2012
Date last updated
10/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Treatment effectiveness, compliance and cardiovascular outcomes with a new supine avoidance therapy for supine-predominant snoring.
Scientific title
In snorers with supine-predominant snoring, is supine avoidance therapy an effective treatment with high patient compliance, and does the therapy improve cardiovascular outcomes?
Secondary ID [1] 280745 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Snoring 286798 0
Condition category
Condition code
Respiratory 287106 287106 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Supine avoidance therapy using a body position monitoring and supine alarm device (BuzzPOD, Gorman ProMed Pty Ltd, VIC Australia).

The study intervention is a small battery operated device worn on the chest each night. It records body position continuously and uses a vibration alarm activated after 5-sec in the supine position to discourage supine sleep. The device can be configured to record body position with or without supine alarm active, allowing long-term posture recordings with or without active therapy. An event button on the device is used to record bed-time and wake-up time to define periods of time in bed.

Participants will be randomised to 2 weeks of inactive or alarm active therapy before crossing over to 2 weeks of the other condition (no washout). Posture recordings over the full trial period will be used to assess supine-avoidance effectiveness and device usage. In-home sleep studies and questionnaires at the end of each 2 week period will be used to assess other outcomes.
Intervention code [1] 285173 0
Treatment: Devices
Comparator / control treatment
This is a relatively short-term cross-over trial for which participants will serve as their own control. The comparator / control is the 2-week period of posture recording alone with a completely inactive supine alarm.
Control group
Active

Outcomes
Primary outcome [1] 287426 0
Study device measured average nightly supine time with active versus inactive supine alarm.
Timepoint [1] 287426 0
Supine time will be measured from study device posture recordings over every night of the trial, downloaded from the study device at the end of each 2 week period. Independent posture measurements will also be collected during overnight full-sleep studies conducted at the end of each 2 week period.
Primary outcome [2] 287427 0
Snoring frequency and intensity, quantified using a portable unattended type III monitor (Visi-lab GreyFlash, Stowood Scientific Instruments Ltd, UK).
Timepoint [2] 287427 0
At baseline, and at the end of both 2-weeks treatment arms.
Primary outcome [3] 287428 0
Sleep efficiency and quality (total sleep time, arousal indicies) measured from full polysomnography in the home setting (Somte, Compumedics, Australia).
Timepoint [3] 287428 0
At the end of both 2-weeks treatment arms.
Secondary outcome [1] 298124 0
Average nightly study device usage assessed from overnight posture changes and participant button responses marking bedtime and wakeup times.
Timepoint [1] 298124 0
Posture recordings are continuous such that overnight position changes and button push responses will be assessed every night of the trial, downloaded from the study device at the end of each 2 week period.
Secondary outcome [2] 298125 0
Reduced frequency and intensity of overnight cardiovascular system disturbances quantified from ECG measured tachycardia and finger photoplethysmogram measured vasoconstriction responses during home polysomnography (Somte, Compumedics, Australia).
Timepoint [2] 298125 0
At the end of both 2-weeks treatment arms.
Secondary outcome [3] 298126 0
Reduced daytime blood pressure measured in clinic (auscultatory method).
Timepoint [3] 298126 0
At baseline, and at the end of both 2-weeks treatment arms.
Secondary outcome [4] 298151 0
Questionnaire measured participant and where applicable bed-partner sleep quality and snoring (Functional Outcomes of Sleep Questionnaire, Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index and Sleep Apnea Symptoms Questionnaire), and Assessment of Quality of Life (AQoL-8D).
Timepoint [4] 298151 0
Baseline and at the end of both 2-weeks treatment arms.

Eligibility
Key inclusion criteria
Snorer:
- Age > or = 18 years
- History of disruptive supine-mainly or supine-only snoring
- Home sleep study confirmed supine-predominant snoring (supine > or = twice non-supine snoring frequency measured from at least 4 hours of recording with at least 30 min in each posture condition)
- AHI < 15 /hr from a home screening study (i.e. to rule out clinically significant OSA).
- Willing to cease any current anti-snoring treatment (e.g. over the counter anti-snoring sprays, nasal dilator strips, tennis ball or other discomfort based supine avoidance treatments etc).

Bed-Partner:
- Regular bed partner (defined as present > or = 5 nights/week) of the snorer participant
- Age > or = 18 years
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Obstructive Sleep Apnoea (Apnoea Hypopnoea Index > or = 15 /hr)
- Co-morbidities that may preclude supine-avoidance treatment (e.g. arthritis, mobility problems preventing non-supine sleep, or a pacemaker given unknown effects of an electronic device in close proximity on the chest)
- Severe oxygen desaturation in sleep (minimum blood oxygen saturation less than 75% during home screening sleep study)
- Sleepiness potentially dangerous and requiring urgent treatment (e.g. history of falling asleep while driving, or Epworth Sleepiness Scale >16) or commercial drivers
- Already on treatment for hypertension

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)
Subjects will be recruited via advertising and randomised to active versus inactive therapy first, followed by cross-over to the other condition after 2 weeks. Treatment allocation will not be disclosed to participants, but effective participant blinding and allocation concealment is not possible with this treatment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/07/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5451 0
5000-5121
Recruitment postcode(s) [2] 5452 0
5125-5174
Recruitment postcode(s) [3] 5453 0
5950

Funding & Sponsors
Funding source category [1] 285528 0
Government body
Name [1] 285528 0
NHMRC project grant 1020892
Country [1] 285528 0
Australia
Primary sponsor type
Individual
Name
A/Prof Peter Catcheside
Address
Adelaide Institute for Sleep Health
Repatriation General Hospital
Daws Road
Daw Park SA 5041
Country
Australia
Secondary sponsor category [1] 284370 0
Individual
Name [1] 284370 0
Miss Biyou Yeo (Jamie)
Address [1] 284370 0
Adelaide Institute for Sleep Health
Repatriation General Hospital
Daws Road
Daw Park SA 5041
Country [1] 284370 0
Australia
Other collaborator category [1] 276884 0
Individual
Name [1] 276884 0
Dr Daniel Stadler
Address [1] 276884 0
Adelaide Institute for Sleep Health
Repatriation General Hospital
Daws Road
Daw Park SA 5041
Country [1] 276884 0
Australia
Other collaborator category [2] 276885 0
Individual
Name [2] 276885 0
A/Prof Nick Antic
Address [2] 276885 0
Adelaide Institute for Sleep Health
Repatriation General Hospital
Daws Road
Daw Park SA 5041
Country [2] 276885 0
Australia
Other collaborator category [3] 276886 0
Individual
Name [3] 276886 0
Prof Doug McEvoy
Address [3] 276886 0
Adelaide Institute for Sleep Health
Repatriation General Hospital
Daws Road
Daw Park SA 5041
Country [3] 276886 0
Australia
Other collaborator category [4] 276887 0
Individual
Name [4] 276887 0
Dr Maree Barnes
Address [4] 276887 0
Institute for Breathing and Sleep
Bowen Centre, Austin Hospital
145 Studley Road
Heidelberg VIC 3084
Country [4] 276887 0
Australia
Other collaborator category [5] 276888 0
Individual
Name [5] 276888 0
Dr Steve Quinn
Address [5] 276888 0
Flinders Clinical Effectiveness
Flinders University
Sturt Road
Bedford Park SA 5042
Country [5] 276888 0
Australia
Other collaborator category [6] 276889 0
Individual
Name [6] 276889 0
Dr Jeremy Mercer
Address [6] 276889 0
Adelaide Institute for Sleep Health
Repatriation General Hospital
Daws Road
Daw Park SA 5041
Country [6] 276889 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287551 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 287551 0
Southern Adelaide Clinical
Human Research Ethics Committee

The Flats G5 - Rooms 3 and 4
Flinders Drive
Flinders Medical Centre
Bedford Park SA 5042
Ethics committee country [1] 287551 0
Australia
Date submitted for ethics approval [1] 287551 0
Approval date [1] 287551 0
25/05/2012
Ethics approval number [1] 287551 0
SAC HREC: 129.12
Ethics committee name [2] 287552 0
The University of Adelaide Human Research Ethics Committee
Ethics committee address [2] 287552 0
Human Research Ethics Committee
Research Ethics and Compliance Unit, Research Branch
Level 7, 115 Grenfell St
The University of Adelaide
Adelaide SA 5005
Ethics committee country [2] 287552 0
Australia
Date submitted for ethics approval [2] 287552 0
Approval date [2] 287552 0
21/06/2012
Ethics approval number [2] 287552 0
UoA HREC: H-2012-084

Summary
Brief summary
This is a research study of a new treatment device designed to discourage snorers from sleeping on their back, when snoring is mainly a problem when asleep on the back.
The hypotheses of this project are that by avoiding sleeping on their back, snorers would have (1) reduced frequency and intensity of snoring episodes, (2) reduced overnight cardiovascular system disturbances, and (3) lower daytime blood pressure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34371 0
Address 34371 0
Country 34371 0
Phone 34371 0
Fax 34371 0
Email 34371 0
Contact person for public queries
Name 17618 0
Miss Biyou Yeo (Jamie)
Address 17618 0
Adelaide Institute for Sleep Health
Repatriation General Hospital
Daws Road
Daw Park SA 5041
Country 17618 0
Australia
Phone 17618 0
+61 8 82751022
Fax 17618 0
Email 17618 0
jamie.yeo@health.sa.gov.au
Contact person for scientific queries
Name 8546 0
A/Prof Peter Catcheside
Address 8546 0
Adelaide Institute for Sleep Health
Repatriation General Hospital
Daws Road
Daw Park SA 5041
Country 8546 0
Australia
Phone 8546 0
+61 8 82751309
Fax 8546 0
Email 8546 0
peter.catcheside@health.sa.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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