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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616001237471
Ethics application status
Approved
Date submitted
29/08/2016
Date registered
6/09/2016
Date last updated
8/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Trial of the Patney open airway device for snoring and mild obstructive sleep apnoea
Scientific title
Validation trial of the Patney open airway device in snorers and mild obstructive sleep apnoea - subjective report of comfort and outcomes
Secondary ID [1] 290041 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive sleep apnoea 300089 0
snoring 300090 0
Condition category
Condition code
Respiratory 299976 299976 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Patney OAD is a pillow device designed to open the airway and reduce snoring / obstructive sleep apnoea. It will be used each night during a period of sleep over one week at subjects home. Detailed instructions will be provided by WellSleep staff trained in its use. Subjects and their partners will provide subjective feedback on their experience.
Intervention code [1] 295763 0
Treatment: Devices
Comparator / control treatment
Control is usual practice with regards to current pillow
Control group
Active

Outcomes
Primary outcome [1] 299456 0
Sleep quality from the use of likert scales (1-10). The questionnaire is an in-house questionnaire designed specifially for this study.
Timepoint [1] 299456 0
After one week of device use
Primary outcome [2] 299540 0
Average total sleep time from sleep diary - in house questionnaire
Timepoint [2] 299540 0
Each night over the one week trial with the product
Secondary outcome [1] 327210 0
Snoring level - sujectively measured by partner sleeping in same bed. This will be on a likert scale and compare to usual snoring.
Timepoint [1] 327210 0
After one week of device use
Secondary outcome [2] 327211 0
Comfort of device. Determined by in house questionnaire designed for this study.
Timepoint [2] 327211 0
after one week of device use

Eligibility
Key inclusion criteria
Objectively determined snoring (snoring plus apnoea Index < 5 /hr) or mild OSA (Apnoea index 5-15/hr)
Not using any other treatment for snoring/mild OSA
Partner sleeping in same bed
Minimum age
25 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Musculoskeletal issues
Severe OSA
Separate sleeping arrangements
Use of other treatment for snoring / mild OSA

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

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 outside Australia
Country [1] 8147 0
New Zealand
State/province [1] 8147 0
Wellington

Funding & Sponsors
Funding source category [1] 294408 0
Commercial sector/Industry
Name [1] 294408 0
Patney Ltd
Address [1] 294408 0
c/- BDO Waikati
1026 Victoria St
Hamilton 3200
New Zealand
Country [1] 294408 0
New Zealand
Primary sponsor type
University
Name
Otago University Wellington
Address
PO Box 7343
Wellington 6242
Country
New Zealand
Secondary sponsor category [1] 293256 0
None
Name [1] 293256 0
Address [1] 293256 0
Country [1] 293256 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295828 0
Health and Disability Ethics Committee
Ethics committee address [1] 295828 0
MOH
PO Box 5013
Wellington
Ethics committee country [1] 295828 0
New Zealand
Date submitted for ethics approval [1] 295828 0
01/07/2016
Approval date [1] 295828 0
18/08/2016
Ethics approval number [1] 295828 0
16/CEN/85

Summary
Brief summary
Treatment devices for snoring and mild OSA available over the counter have not been well validated. This study aims to determine whether a new product - the Patney Open Airway Device is suitable for people who snore and have mild OSA in terms of treating these issues. Patients will initially trial the device for one week and provide feedback on the comfort of the device plus the effect on symptoms.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68646 0
Dr Angela Campbell
Address 68646 0
C/- Dept Medicine
University of Otago Wellington
PO Box 7343
Wellington
Country 68646 0
New Zealand
Phone 68646 0
+64 4 9208819
Fax 68646 0
Email 68646 0
angela.campbell@otago.ac.nz
Contact person for public queries
Name 68647 0
Dr Angela Campbell
Address 68647 0
C/- Dept Medicine
University of Otago Wellington
PO Box 7343
Wellington
Country 68647 0
New Zealand
Phone 68647 0
+64 4 9208819
Fax 68647 0
Email 68647 0
angela.campbell@otago.ac.nz
Contact person for scientific queries
Name 68648 0
Dr Angela Campbell
Address 68648 0
C/- Dept Medicine
University of Otago Wellington
PO Box 7343
Wellington
Country 68648 0
New Zealand
Phone 68648 0
+64 4 9208819
Fax 68648 0
Email 68648 0
angela.campbell@otago.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary