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
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).
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.
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 →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.
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.
Exclusion:
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.
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
Percent change in loud snoring time
The percentage change in snoring time in the "ON" versus "OFF" period
Time frame: up to 5 hours
Change in AHI
Change in AHI in the "ON" versus "OFF" period
Time frame: 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
Time frame: 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
Time frame: up to 5 hours
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
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
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
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
Tolerability of the ZENS Device
% of time worn during sleep
Time frame: up to 12 hours
Plan to share: No
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.
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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