Snore Positive Airway Pressure Trial

Non-Apnoeic Snorers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03201055
• Other study ID #: MA100517
• Status: Completed
• Phase: N/A
• Start date: October 2, 2017
• Est. completion date: July 31, 2019

Study information

• Verified date: February 2021
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Non-Apnoeic Snorers

Intervention

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.

Locations

Country	Name	City	State
New Zealand	EdenSleep	New Plymouth

Sponsors (2)

Lead Sponsor	Collaborator
ResMed	Eden Sleep

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Objectively assess participant compliance with the Snore PAP system	Hours used per night	28 Nights