Snore Positive Airway Pressure Trial

NCT ID: NCT03201055

Last Updated: 2021-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-02
• Study Completion Date: 2019-07-31

Brief 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.

Conditions

Non-Apnoeic Snorers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Non Apnoeic Snorers

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

Group Type: EXPERIMENTAL

Snore PAP System

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eden Sleep

UNKNOWN

Sponsor Role: collaborator

ResMed

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

EdenSleep

New Plymouth, , New Zealand

Countries

New Zealand

Other Identifiers

MA100517

Identifier Type: -

Identifier Source: org_study_id