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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03201055




Registration number
NCT03201055
Ethics application status
Date submitted
22/06/2017
Date registered
28/06/2017
Date last updated
18/02/2021

Titles & IDs
Public title
Snore Positive Airway Pressure Trial
Scientific title
Assessment of Performance, Usability and Acceptance of a Continuous Positive Airway Pressure System to Alleviate Self-reported Snore in Non-apnoeic Participants
Secondary ID [1] 0 0
MA100517
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Apnoeic Snorers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Subjectively assess the participant and bed partner acceptability and usability of Snore PAP system
Timepoint [1] 0 0
28 Nights
Secondary outcome [1] 0 0
Subjectively assess the performance of the Snore PAP system in relieving: self-reported and bed partner reported snore in non-apnoeic participants.
Timepoint [1] 0 0
28 Nights
Secondary outcome [2] 0 0
Objectively assess participant compliance with the Snore PAP system
Timepoint [2] 0 0
28 Nights

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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/10/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/07/2019
Sample size
Target
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
New Plymouth

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ResMed
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Eden Sleep
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03201055
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries