ClinicalTrials.gg
CompletedNCT04063917Updated Jun 24, 2021

Safety, and Tolerability of the ZENS Device (PLUTO)

An interventional study of ZENS in Snoring and Obstructive Sleep Apnea, sponsored by Zennea Technologies Inc.. Completed at 2 sites in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-24.

Sponsored by Zennea Technologies Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Snoring
  • Obstructive Sleep Apnea

Keywords

  • Sleep Apnea
  • Snoring
03

In context

Snoring

122 studies on the registry are indexed under Snoring; 15 are open to participants now.

This study's enrollment of 45 is close to the median of 43 across 95 interventional studies indexed under Snoring.

Browse Snoring studies →

Lead sponsor

This is the only study on the registry with Zennea Technologies Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Adult (age of majority).
  2. Willing and able to provide written .
  3. \<35.
  4. Neck circumference \<18 inches.
  5. History of disruptive snoring for most of the night, 12 or more of the last 14 nights.
  6. 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.
  7. 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.
  8. 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.
  9. Willing to refrain from use of alcohol, sedative hypnotics, or recreational drugs for 24 hours prior to and during the study.

Exclusion criteria

Exclusion:

  1. 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).
  2. Known sleep disturbance other than snoring (insomnia, parasomnia, narcolepsy, restless legs syndrome, circadian rhythm disorder, or other disorder likely to interfere with the study).
  3. Fixed anatomical abnormality of the upper airway (e.g. history of head or neck trauma, head and neck , previous tracheotomy, subglottic stenosis, deformed uvula, aglossia) from trauma, malignancy, prior surgery, or congenital condition.
  4. 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.
  5. Enflamed/enlarged tonsils.
  6. Use of another snoring treatment (CPAP, medication or oral appliance) in the 72 hours prior to the overnight visit.
  7. Anatomic neck or skin abnormalities likely to interfere with fixation of the ZENS Device.
  8. Presence of an implantable medical device susceptible to electrical interference (e.g. pacemaker or defibrillator).
  9. History of epilepsy.
  10. Use of sedatives, hypnotics, recreational drug or alcohol in the 24 hours prior to the study.
  11. Known allergy to medical tape.
  12. Any severe skin condition affecting the head and neck likely to be aggravated by adhesives (e.g. psoriasis, eczema).
  13. Recent surgery to the face or neck (i.e. within the past 5 years).
  14. Inability to wear something on the neck or tolerate PSG procedure.
  15. Pregnancy.
  16. 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.).
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    Sequence 1

    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.

    Device: ZENS

  • Experimental
    Sequence 2

    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

    Device: ZENS

Interventions

  • DeviceZENS

    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.

06

What researchers measure

Primary outcomes

  1. Percent change in loud snoring time

    The percentage change in snoring time in the "ON" versus "OFF" period

    Time frame: up to 5 hours

Secondary outcomes

  1. Change in AHI

    Change in AHI in the "ON" versus "OFF" period

    Time frame: up to 5 hours

  2. 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

    Time frame: up to 5 hours

  3. 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

    Time frame: up to 5 hours

  4. Difference in the mean oxygen saturation levels

    Difference in the mean oxygen saturation levels in the "ON" versus "OFF" phase

    Time frame: up to 5 hours

  5. Number of patients with successful snoring reduction

    ≥ 25% reduction in snoring intensity in the "OFF" versus the "ON" period.

    Time frame: up to 5 hours

Other outcomes

  1. Incidence of adverse events, serious adverse events, device deficiencies and unanticipated adverse device effects

    Safety and tolerability of intervention

    Time frame: up to 96 hours

  2. Percent of the time the ZENS Device was adhered to the participant

    % time worn during entire study (awake and asleep)

    Time frame: up to 12 hours

  3. Tolerability of the ZENS Device

    % of time worn during sleep

    Time frame: up to 12 hours

07

Study locations

2 sites
  • University of Calgary, FMC Sleep Centre
    Calgary, Alberta T2N 4N1, Canada
  • Tranq Sleep Centre
    Cranbrook, British Columbia V1C 3W3, Canada
08

References and documents

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2019 to primary completion in Apr 2021, 17 months.

Of 45 interventional studies with no phase under Snoring, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 31. This study's 17 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 19, 2019
First posted
Aug 21, 2019
StartActual
Nov 1, 2019
Primary completionActual
Apr 1, 2021
CompletionActual
Jun 18, 2021
Last update
Jun 24, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04063917
Lead sponsor
Zennea Technologies Inc.
Collaborators
University of Calgary, Interior Health
Responsible party
Sponsor
First posted
Aug 21, 2019
Start date
Nov 1, 2019
Primary completion
Apr 1, 2021
Completion
Jun 18, 2021
Last update
Jun 24, 2021

Study contacts

Marcus Povitz, MD
principal investigator · University of Calgary

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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