SnoringNCT04063917
Safety, and Tolerability of the ZENS Device (PLUTO)
A study testing ZENS in people with Snoring and Obstructive Sleep Apnea, run by Zennea Technologies Inc. at 2 sites in Canada.
Trial summary
The primary objective of the PLUTO study is to evaluate the safety and tolerability of the ZENS transcutaneous nerve stimulator device in primary snorers and those with mild obstructive sleep apnea. The study will assess the impact of ZENS on snoring frequency, duration, and other relevant sleep parameters. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Snoring, Obstructive Sleep Apnea
- What is being tested?
- ZENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Nov 2019to 18 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult (age of majority).
- Willing and able to provide written informed consent.
- BMI <35.
- Neck circumference <18 inches.
- History of disruptive snoring for most of the night, 12 or more of the last 14 nights.
- Level 3 at-home sleep test (Sagatech SnoreSat Sleep Recorder, Philips Alice OneNight or equivalent) recording from the past 12 months (prior to enrolment) with more than 4 hours of both oximetry and flow data for review; or willing to undergo a level 3 sleep test prior to overnight in-laboratory polysomnography assessment. The respiratory disturbance index (RDI) must be <15events/hour.
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- Ability and willingness to shave significant facial hair (i.e. be clean shaven) for the overnight visit; and to cease wearing cosmetic products and/or moisturizing cream and/or remove excessive oil in the chin / jaw region (i.e. be clean skinned) for the overnight visit; and to wear clothing that covers the chest (e.g. a t-shirt) for the duration of the overnight visit.
- Willing to participate in overnight portion of study without use of another snoring/OSA treatment (CPAP, oral appliance) in the 72 hours prior to the overnight visit.
- Willing to refrain from use of alcohol, sedative hypnotics, or recreational drugs for 24 hours prior to and during the study.
Who cannot join
- Prior diagnosis of moderate or severe OSA (AASM defines OSA severity as: Mild=AHI ≥5 and <15; Moderate=AHI ≥15 and <30; Severe = ≥30/hour).
- Known sleep disturbance other than snoring (insomnia, parasomnia, narcolepsy, restless legs syndrome, circadian rhythm disorder, or other disorder likely to interfere with the study).
- Fixed anatomical abnormality of the upper airway (e.g. history of head or neck trauma, head and neck malignancy, previous tracheotomy, subglottic stenosis, deformed uvula, aglossia) from trauma, malignancy, prior surgery, or congenital condition.
- Individuals with a history of severe nasal obstruction due to anatomical problems such as deviated septum, previously broken nose or non-anatomical factors such as chronic rhinitis or nasal polyposis.
- Enflamed/enlarged tonsils.
- Use of another snoring treatment (CPAP, medication or oral appliance) in the 72 hours prior to the overnight visit.
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- Anatomic neck or skin abnormalities likely to interfere with fixation of the ZENS Device.
- Presence of an implantable medical device susceptible to electrical interference (e.g. pacemaker or defibrillator).
- History of epilepsy.
- Use of sedatives, hypnotics, recreational drug or alcohol in the 24 hours prior to the study.
- Known allergy to medical tape.
- Any severe skin condition affecting the head and neck likely to be aggravated by adhesives (e.g. psoriasis, eczema).
- Recent surgery to the face or neck (i.e. within the past 5 years).
- Inability to wear something on the neck or tolerate PSG procedure.
- Pregnancy.
- Any other criteria, which would make the participant unsuitable to participate in this study as determined by the site Principal Investigator (e.g. uncontrolled drug and/or alcohol addiction, extreme frailty, comorbidities, ongoing medication regimen, cognitive ability to follow instructions, etc.).
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University of Calgary, FMC Sleep Centre
Calgary, Alberta, T2N 4N1
Tranq Sleep Centre
Cranbrook, British Columbia, V1C 3W3
About this study
Official title: An Initial Investigation of the Safety and Tolerability of Transcutaneous Stimulation of the Hypoglossal Nerve for the Treatment of Primary Snoring and Mild Sleep Apnea Using the ZENS Transcutaneous Nerve Stimulator (PLUTO)
The primary objective of the PLUTO study is to evaluate the safety and tolerability of the ZENS transcutaneous nerve stimulator device in primary snorers and those with mild obstructive sleep apnea. The study will assess the impact of ZENS on snoring frequency, duration, and other relevant sleep parameters. The intended purpose of the investigational device is to deliver a transcutaneous electrical stimulation signal to the hypoglossal nerve in the "ON" phase in order to alter the apnea hypopnea index (AHI), as well as mean snoring burden (intensity, duration), and to deliver no signal in the "OFF" phase of the study as a means for comparison. Subjects utilizing the ZENS Device will experience a reduction in snoring during the "ON" versus "OFF" phase, as quantified by a reduction in the percentage of time per hour of snoring (≥40 dB) in the active ZENS Device ("ON" phase) versus the inactive ZENS Device ("OFF" phase).
Read the detailed description
After indicating their consent to contact and signing an Informed Consent Form, potential participants will undergo a screening assessment that includes a review of their medical history, a focused physical exam, and a level 3 at-home sleep test (Sagatech SnoreSat Sleep Recorder, Philips Alice OneNight or equivalent), if not already available in the medical records). At the screening visit potential participants' eligibility for the study will be evaluated against the study inclusion and exclusion criteria.
Following confirmation of eligibility, up to 45 (n=45) participants will be scheduled for their overnight in-laboratory PSG, which must occur no more than 12 weeks after screening has taken place. A final determination of eligibility and "enrollment" is completed when inclusion and exclusion criteria are verified on the day of the study visit. Those who do not meet inclusion and exclusion criteria on the day of the study will be deemed "screening failures".
Participants will wear the ZENS Device for the 8 to 12-hour overnight in-laboratory polysomnography assessment. Participants will be monitored for and asked about any adverse events and device effects that they experience during the overnight sleep study.
Participants will be contacted by the site via telephone 24 to 96 hours after the overnight sleep study to determine if any adverse events and device effects were experienced late after the overnight polysomnography. After the telephone follow-up, participation in the study is complete.
- Conditions
- Snoring, Obstructive Sleep Apnea
- Being tested
- ZENS
- Keywords
- Sleep Apnea, Snoring
- Medical subject headings
- Snoring, Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZENSDevice
ZENS transcutaneous nerve stimulator (ZENS Device), a wearable and non-invasive device which stimulates nerves in the neck to reduce airway obstruction and maintain muscular tension while sleeping to reduce snoring severity.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Participants allocated to Sequence 1 will complete the overnight sleep study with the ZENS device "ON" for the first half and "OFF" for the second half. Receives: Device: ZENS |
| Sequence 2 | Experimental | Participants allocated to Sequence 1 will complete the overnight sleep study with the ZENS device "OFF" for the first half and "ON" for the second half Receives: Device: ZENS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in loud snoring time
The percentage change in snoring time in the "ON" versus "OFF" period
Measured: up to 5 hours
Secondary outcomes (5)
Change in AHI
Change in AHI in the "ON" versus "OFF" period
Measured: up to 5 hours
Percentage difference of time (minutes) per hour of sleep with loud snoring
Percentage difference of time (minutes) per hour of sleep with loud snoring (≥40) in the "ON" versus "OFF" phase
Measured: up to 5 hours
Change in the number of arousals and awakenings in the "ON" versus "OFF" phase
Change in the number of arousals and awakenings in the "ON" versus "OFF" phase
Measured: up to 5 hours
Difference in the mean oxygen saturation levels
Difference in the mean oxygen saturation levels in the "ON" versus "OFF" phase
Measured: up to 5 hours
Number of patients with successful snoring reduction
≥ 25% reduction in snoring intensity in the "OFF" versus the "ON" period.
Measured: up to 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start1 Nov 2019
- Primary completion1 Apr 2021
- Study completion18 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SnoringStudies 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
- Crossover
- Model description
- Multi-center, open label randomized 2x2 cross-over sleep study of the ZENS transcutaneous hypoglossal nerve stimulator in the "ON" (active) versus "OFF" (passive) setting during a single over-night sleep study.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zennea Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Calgary, Interior Health
- Responsible party
- Sponsor
- Investigators
- Marcus Povitz, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063917
- Sponsor's protocol ID
- CIP-001
- Status last verified
- Jun 2021
- First submitted
- 19 Aug 2019
- Last updated
- 24 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Initial Investigation of the Safety and Tolerability of Transcutaneous Stimulation of the Hypoglossal Nerve for the Treatment of Primary Snoring and Mild Sleep Apnea Using the ZENS Transcutaneous Nerve Stimulator (PLUTO)
- ClinicalTrials.gov ID
- NCT04063917
- Acronym / sponsor ID
- CIP-001
- Conditions
- Snoring, Obstructive Sleep Apnea
- Keywords
- Sleep Apnea, Snoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Zennea Technologies Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Calgary, Interior Health
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 18 Jun 2021 (actual)
- First posted
- 21 Aug 2019 (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 primary objective of the PLUTO study is to evaluate the safety and tolerability of the ZENS transcutaneous nerve stimulator device in primary snorers and those with mild obstructive sleep apnea. The study will assess the impact of ZENS on snoring frequency, duration, and other relevant sleep parameters. The intended purpose of the investigational device is to deliver a transcutaneous electrical stimulation signal to the hypoglossal nerve in the "ON" phase in order to alter the apnea hypopnea index (AHI), as well as mean snoring burden (intensity, duration), and to deliver no signal in the "OFF" phase of the study as a means for comparison. Subjects utilizing the ZENS Device will experience a reduction in snoring during the "ON" versus "OFF" phase, as quantified by a reduction in the percentage of time per hour of snoring (≥40 dB) in the active ZENS Device ("ON" phase) versus the inactive ZENS Device ("OFF" phase).
Detailed description
After indicating their consent to contact and signing an Informed Consent Form, potential participants will undergo a screening assessment that includes a review of their medical history, a focused physical exam, and a level 3 at-home sleep test (Sagatech SnoreSat Sleep Recorder, Philips Alice OneNight or equivalent), if not already available in the medical records). At the screening visit potential participants' eligibility for the study will be evaluated against the study inclusion and exclusion criteria.
Following confirmation of eligibility, up to 45 (n=45) participants will be scheduled for their overnight in-laboratory PSG, which must occur no more than 12 weeks after screening has taken place. A final determination of eligibility and "enrollment" is completed when inclusion and exclusion criteria are verified on the day of the study visit. Those who do not meet inclusion and exclusion criteria on the day of the study will be deemed "screening failures".
Participants will wear the ZENS Device for the 8 to 12-hour overnight in-laboratory polysomnography assessment. Participants will be monitored for and asked about any adverse events and device effects that they experience during the overnight sleep study.
Participants will be contacted by the site via telephone 24 to 96 hours after the overnight sleep study to determine if any adverse events and device effects were experienced late after the overnight polysomnography. After the telephone follow-up, participation in the study is complete.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multi-center, open label randomized 2x2 cross-over sleep study of the ZENS transcutaneous hypoglossal nerve stimulator in the "ON" (active) versus "OFF" (passive) setting during a single over-night sleep study.
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Device: ZENSParticipants allocated to Sequence 1 will complete the overnight sleep study with the ZENS device "ON" for the first half and "OFF" for the second half. |
| Sequence 2 | Experimental | Device: ZENSParticipants allocated to Sequence 1 will complete the overnight sleep study with the ZENS device "OFF" for the first half and "ON" for the second half |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult (age of majority).
- Willing and able to provide written informed consent.
- BMI <35.
- Neck circumference <18 inches.
- History of disruptive snoring for most of the night, 12 or more of the last 14 nights.
Key exclusion criteria (16 listed)
- Prior diagnosis of moderate or severe OSA (AASM defines OSA severity as: Mild=AHI ≥5 and <15; Moderate=AHI ≥15 and <30; Severe = ≥30/hour).
- Known sleep disturbance other than snoring (insomnia, parasomnia, narcolepsy, restless legs syndrome, circadian rhythm disorder, or other disorder likely to interfere with the study).
- Fixed anatomical abnormality of the upper airway (e.g. history of head or neck trauma, head and neck malignancy, previous tracheotomy, subglottic stenosis, deformed uvula, aglossia) from trauma, malignancy, prior surgery, or congenital condition.
- Individuals with a history of severe nasal obstruction due to anatomical problems such as deviated septum, previously broken nose or non-anatomical factors such as chronic rhinitis or nasal polyposis.
- Enflamed/enlarged tonsils.
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 |
|---|---|---|
| ZENSZENS transcutaneous nerve stimulator (ZENS Device), a wearable and non-invasive device which stimulates nerves in the neck to reduce airway obstruction and maintain muscular tension while sleeping to reduce snoring severity. | Device | Sequence 1, Sequence 2 |
Primary outcome
Percent change in loud snoring time
Time frame: up to 5 hours
The percentage change in snoring time in the "ON" versus "OFF" period
5 secondary outcomes
Change in AHI
Time frame: up to 5 hours
Percentage difference of time (minutes) per hour of sleep with loud snoring
Time frame: up to 5 hours
Change in the number of arousals and awakenings in the "ON" versus "OFF" phase
Time frame: up to 5 hours
Difference in the mean oxygen saturation levels
Time frame: up to 5 hours
Number of patients with successful snoring reduction
Time frame: up to 5 hours
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 24 Jun 2021.
- Zennea Technologies websiteLink provided by the sponsor.
- 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.
Marcus Povitz, MD principal investigator
University of Calgary
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ZENS in people with Snoring and Obstructive Sleep Apnea, run by Zennea Technologies Inc. at 2 sites in Canada.
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 16 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 24 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
Percent change in loud snoring time (time frame: up to 5 hours). 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 24 Jun 2021.