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OpenTrials
Completed

NCT Number: NCT03201055

Snore Positive Airway Pressure Trial

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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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

EdenSleep

New Plymouth, 4312, New Zealand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Snore PAP System

Device

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.

Primary outcomes

  1. Subjectively assess the participant and bed partner acceptability and usability of Snore PAP system

    Time frame: 28 Nights

    Subjective assessment will be assessed using the Likert scale using a 0-10 scale. With 0 being very negative and 10 being very positive.

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.

    Time frame: 28 Nights

    Subjective assessment will be assessed using the Likert scale using a 0-10 scale. With 0 being very negative and 10 being very positive.

  2. Objectively assess participant compliance with the Snore PAP system

    Time frame: 28 Nights

    Hours used per night

Sponsors and collaborators

Lead sponsor

ResMed

Industry

Collaborators

  • Eden Sleep

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jun 28, 2017
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.