Non-Apnoeic SnorersNCT03201055
Snore Positive Airway Pressure Trial
A study testing Snore PAP System in people with Non-Apnoeic Snorers, run by ResMed at 1 site in New Zealand.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-Apnoeic Snorers
- What is being tested?
- Snore PAP System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNew Zealand
- Study dates
- 2 Oct 2017to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Performance, Usability and Acceptance of a Continuous Positive Airway Pressure System to Alleviate Self-reported Snore in Non-apnoeic Participants
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
- Being tested
- Snore PAP System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Snore PAP SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Non Apnoeic Snorers | Experimental | Patient's use the Snore Positive airway pressure device for 28 nights. Receives: Device: Snore PAP System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 Nights
Secondary outcomes (2)
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.
Measured: 28 Nights
Objectively assess participant compliance with the Snore PAP system
Hours used per night
Measured: 28 Nights
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start2 Oct 2017
- Primary completion31 Jul 2018
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Apnoeic SnorersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eden Sleep
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03201055
- Sponsor's protocol ID
- MA100517
- Status last verified
- Feb 2021
- First submitted
- 22 Jun 2017
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Performance, Usability and Acceptance of a Continuous Positive Airway Pressure System to Alleviate Self-reported Snore in Non-apnoeic Participants
- ClinicalTrials.gov ID
- NCT03201055
- Acronym / sponsor ID
- MA100517
- Conditions
- Non-Apnoeic Snorers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Collaborators
- Eden Sleep
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 28 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non Apnoeic Snorers | Experimental | Device: Snore PAP SystemPatient's use the Snore Positive airway pressure device for 28 nights. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Snore PAP SystemThe 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. | Device | Non Apnoeic Snorers |
Primary outcome
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.
2 secondary outcomes
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
Objectively assess participant compliance with the Snore PAP system
Time frame: 28 Nights
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Non-Apnoeic Snorers
Enrolling by invitation
Swallowing in OSA & CPAP Intolerance
Sleep Apnea, Obstructive, Healthy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Snore PAP System in people with Non-Apnoeic Snorers, run by ResMed at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjectively assess the participant and bed partner acceptability and usability of Snore PAP system (time frame: 28 Nights). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.