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CompletedNCT03201055Updated Feb 18, 2021

Snore Positive Airway Pressure Trial

An interventional study of Snore PAP System in Non-Apnoeic Snorers, sponsored by ResMed. Completed at 1 site in New Zealand. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-18.

Sponsored by ResMed · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Non-Apnoeic Snorers
03

In context

Lead sponsor

ResMed is the lead sponsor of 105 studies on the registry; 13 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 6 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Non Apnoeic Snorers

    Patient's use the Snore Positive airway pressure device for 28 nights.

    Device: Snore PAP System

Interventions

  • DeviceSnore 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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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 28 Nights

Secondary outcomes

  1. 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.

    Time frame: 28 Nights

  2. Objectively assess participant compliance with the Snore PAP system

    Hours used per night

    Time frame: 28 Nights

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Study locations

1 site
  • EdenSleep
    New Plymouth, 4312, New Zealand
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03201055
Lead sponsor
ResMed
Collaborators
Eden Sleep
Responsible party
Sponsor
First posted
Jun 28, 2017
Start date
Oct 2, 2017
Primary completion
Jul 31, 2018
Completion
Jul 31, 2019
Last update
Feb 18, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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