Snore Positive Airway Pressure Trial

ResMed

Status: Completed

Conditions: Non-Apnoeic Snorers

Treatments: Device: Snore PAP System

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03201055

MA100517

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Non Apnoeic Snorers

Experimental group

Description:

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

Treatment:

Device: Snore PAP System