Sleep ApneaNCT04250584
Substantial Equivalence of iSlpr™ and SomnoDent® Classic in the Treatment of Snoring and Mild to Moderate Sleep Apnoea.
A study testing iSlpr™ and SomnoDent® Classic in people with Sleep Apnea and Snoring, run by BioAnalytics Holdings Pty Ltd.
Trial summary
The study is a thirty three week, prospective, open-label, randomized, parallel-group non-inferiority study. The study aims to investigate the Substantial Equivalence of a novel mandibular device called iSlpr™, produced by BioAnalytics, to a currently approved device, SomnoDent® Classic, in the treatment of mild to… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sleep Apnea, Snoring
- What is being tested?
- iSlpr™ and SomnoDent® Classic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Mar 2020to Jun 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older and younger than 75 years at time of screening
- Snoring and mild to moderate sleep apnoea ( AHI > 5 and < 30 per hr)
- Written informed consent
- Able to complete the study procedures within the study timeline.
Who cannot join
- Women who are pregnant or breast-feeding
- Central sleep apnoea
- Severe respiratory disorders
- Loose teeth or advanced periodontal disease
- Lateral bruxers
- Full or partial dentures
Show all 14Show fewer
- Temporomandibular Joint (TMJ) abnormalities, pain or dysfunction
- Other teeth, jaw or gum disorders would preclude use of the device
- Cardiovascular comorbidities or stroke/heart attack in past 12 months
- Drug-addiction
- Major Depressive Disorder or psychosis
- Undergoing concomitant therapy for OSA/Snoring
- current or previous therapy with SomnoDent Classic
- Professional drivers or machine operators required to be undertaking CPAP
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Investigation of the Substantial Equivalence of a Novel Mandibular Advancement Device, iSlpr™, With SomnoDent® Classic, in a Non-inferiority Study, in the Treatment of Snoring and Mild to Moderate Obstructive Sleep Apnoea.
The study is a thirty three week, prospective, open-label, randomized, parallel-group non-inferiority study.
The study aims to investigate the Substantial Equivalence of a novel mandibular device called iSlpr™, produced by BioAnalytics, to a currently approved device, SomnoDent® Classic, in the treatment of mild to moderate Obstructive Sleep Apnoea (OSA) and snoring.
Read the detailed description
The objective of this study is to determine if the BioAnalytics device, iSlpr™, has a similar safety and efficacy profile to a commonly used device, SomnoDent® Classic, in the treatment of snoring and mild to moderate Obstructive Sleep Apnoea.
The target population will be males and females aged from 18 years to less than 75 years, who have been diagnosed with snoring and mild to moderate sleep apnoea.
Participants will remain on study from screening visit to end of study visit; a total of approximately 33 weeks.
This study includes -
- a screening period of up to 28 days
- a 2 week device initiation period
- a 24 week treatment period
- Conditions
- Sleep Apnea, Snoring
- Being tested
- iSlpr™, SomnoDent® Classic
- Medical subject headings
- Sleep Apnea Syndromes, Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iSlpr™Device
mandibular advancement device
SomnoDent® ClassicDevice
mandibular advancement device
| Study group | Role | What they receive |
|---|---|---|
| Test Device | Experimental | Novel Mandibular Advancement Device Receives: Device: iSlpr™ |
| Predicate Device | Active comparator | Predicate Mandibular Advancement Device Receives: Device: SomnoDent® Classic |
What is being measured
The primary outcome is the main question the study is designed to answer.
AHI
Apnea Hypopnea Index
Measured: 24 weeks
ODI
Oxygen Desaturation Index
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study startMar 2020 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioAnalytics Holdings Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04250584
- Sponsor's protocol ID
- BAH001
- Status last verified
- Jan 2020
- First submitted
- 30 Jan 2020
- Last updated
- 31 Jan 2020
- 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 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Substantial Equivalence of a Novel Mandibular Advancement Device, iSlpr™, With SomnoDent® Classic, in a Non-inferiority Study, in the Treatment of Snoring and Mild to Moderate Obstructive Sleep Apnoea.
- ClinicalTrials.gov ID
- NCT04250584
- Acronym / sponsor ID
- BAH001
- Conditions
- Sleep Apnea, Snoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- BioAnalytics Holdings Pty LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2020 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 31 Jan 2020 (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.
The study is a thirty three week, prospective, open-label, randomized, parallel-group non-inferiority study.
The study aims to investigate the Substantial Equivalence of a novel mandibular device called iSlpr™, produced by BioAnalytics, to a currently approved device, SomnoDent® Classic, in the treatment of mild to moderate Obstructive Sleep Apnoea (OSA) and snoring.
Detailed description
The objective of this study is to determine if the BioAnalytics device, iSlpr™, has a similar safety and efficacy profile to a commonly used device, SomnoDent® Classic, in the treatment of snoring and mild to moderate Obstructive Sleep Apnoea.
The target population will be males and females aged from 18 years to less than 75 years, who have been diagnosed with snoring and mild to moderate sleep apnoea.
Participants will remain on study from screening visit to end of study visit; a total of approximately 33 weeks.
This study includes -
- a screening period of up to 28 days
- a 2 week device initiation period
- a 24 week treatment period
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Device | Experimental | Device: iSlpr™Novel Mandibular Advancement Device |
| Predicate Device | Active comparator | Device: SomnoDent® ClassicPredicate Mandibular Advancement Device |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older and younger than 75 years at time of screening
- Snoring and mild to moderate sleep apnoea ( AHI > 5 and < 30 per hr)
- Written informed consent
- Able to complete the study procedures within the study timeline.
Key exclusion criteria (14 listed)
- Women who are pregnant or breast-feeding
- Central sleep apnoea
- Severe respiratory disorders
- Loose teeth or advanced periodontal disease
- Lateral bruxers
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 |
|---|---|---|
| iSlpr™mandibular advancement device | Device | Test Device |
| SomnoDent® Classicmandibular advancement device | Device | Predicate Device |
Primary outcome
AHI
Time frame: 24 weeks
Apnea Hypopnea Index
ODI
Time frame: 24 weeks
Oxygen Desaturation Index
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing iSlpr™ and SomnoDent® Classic in people with Sleep Apnea and Snoring, run by BioAnalytics Holdings Pty Ltd.
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 4 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cyril Jones (+61 419 594 572, cjones@bioanalytics.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AHI (time frame: 24 weeks). The study lists 2 primary outcomes in all. 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 31 Jan 2020.