Snore Positive Airway Pressure Trial

Assessment of Performance, Usability and Acceptance of a Continuous Positive Airway Pressure System to Alleviate Self-reported Snore in Non-apnoeic Participants

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.

Study Overview

• Status: Completed
• Conditions: Non-Apnoeic Snorers
• Intervention / Treatment: Device: Snore PAP System

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• New Zealand
  • New Plymouth, New Zealand, 4312
    • EdenSleep

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Non Apnoeic Snorers; Patient's use the Snore Positive airway pressure device for 28 nights.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjectively assess the participant and bed partner acceptability and usability of Snore PAP system	Subjective assessment will be assessed using the Likert scale using a 0-10 scale. With 0 being very negative and 10 being very positive.	28 Nights

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjectively assess the performance of the Snore PAP system in relieving: self-reported and bed partner reported snore in non-apnoeic participants.	Subjective assessment will be assessed using the Likert scale using a 0-10 scale. With 0 being very negative and 10 being very positive.	28 Nights
Objectively assess participant compliance with the Snore PAP system	Hours used per night	28 Nights

Collaborators and Investigators

• Sponsor: ResMed
• Collaborators: Eden Sleep

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2017
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: June 22, 2017
• First Submitted That Met QC Criteria: June 26, 2017
• First Posted (Actual): June 28, 2017

Study Record Updates

• Last Update Posted (Actual): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 17, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: MA100517

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No