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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03201055
Registration number
NCT03201055
Ethics application status
Date submitted
22/06/2017
Date registered
28/06/2017
Titles & IDs
Public title
Snore Positive Airway Pressure Trial
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Scientific title
Assessment of Performance, Usability and Acceptance of a Continuous Positive Airway Pressure System to Alleviate Self-reported Snore in Non-apnoeic Participants
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Secondary ID [1]
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MA100517
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-Apnoeic Snorers
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Snore PAP System
Experimental: Non Apnoeic Snorers - Patient's use the Snore Positive airway pressure device for 28 nights.
Treatment: Devices: Snore PAP System
The Snore PAP system delivers a set Continuous Positive Airway Pressure (CPAP) and consists of a CPAP flow generator and an approved pillows mask.The system will deliver a fixed positive airflow to the participant via approved tubing and pillows mask.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Subjectively assess the participant and bed partner acceptability and usability of Snore PAP system
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Assessment method [1]
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Subjective assessment will be assessed using the Likert scale using a 0-10 scale. With 0 being very negative and 10 being very positive.
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Timepoint [1]
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28 Nights
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Secondary outcome [1]
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Subjectively assess the performance of the Snore PAP system in relieving: self-reported and bed partner reported snore in non-apnoeic participants.
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Assessment method [1]
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Subjective assessment will be assessed using the Likert scale using a 0-10 scale. With 0 being very negative and 10 being very positive.
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Timepoint [1]
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28 Nights
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Secondary outcome [2]
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Objectively assess participant compliance with the Snore PAP system
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Assessment method [2]
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Hours used per night
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Timepoint [2]
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28 Nights
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Eligibility
Key inclusion criteria
Inclusion Criteria
* Participants willing to provide written informed consent
* Participants who can read and comprehend written and spoken English
* Participants who are = 18 years of age
* Participants are CPAP naïve
* Participants who are self/ partner reported snorers
* Participants whose ApneaLink study results demonstrate snore
* Participants who are willing to use Nice system in place of current non prescribed methods for alleviating snore
* Participants have a bed partner
* Participant's bed partner willing to answer assessment questionnaire
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Exclusion Criteria
* Participants previously diagnosed with obstructive or central sleep apnoea
* Participants whose ApneaLink home study indicates AHI =6
* Participants who are pregnant or breastfeeding
* Participants who have a pre-existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (< 2years) case of pneumonia or lung infection; lung injury)
* Participants with severe bullous lung disease, history of pneumothorax, pathologically low blood pressure, dehydration, cerebrospinal fluid leak, recent cranial surgery or trauma.
* Participants who cannot participate for the duration of the trial
* Participants who are established on bi-level support therapy
* Participants currently using a prescribed medication/ device to alleviate snore
* Participants who are physically unable to comply with the protocol- no access to internet to conduct online visits with researcher or unable to attend clinic for visit
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/10/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/07/2019
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Sample size
Target
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Accrual to date
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Final
24
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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New Plymouth
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
ResMed
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Eden Sleep
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will aim to assess the acceptance of the Snore PAP system as a treatment concept for snore. The study will subjectively assess participant and bed partner acceptability and usability of the Snore PAP system and objectively assess participant compliance with the Snore PAP system.
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Trial website
https://clinicaltrials.gov/study/NCT03201055
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03201055