Status:
COMPLETED
Safety, and Tolerability of the ZENS Device (PLUTO)
Lead Sponsor:
Zennea Technologies Inc.
Collaborating Sponsors:
University of Calgary
Interior Health
Conditions:
Snoring
Obstructive Sleep Apnea
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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. T...
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 ph...
Eligibility Criteria
Inclusion
- Inclusion:
- 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.
- 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.
- Exclusion:
- 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.
- 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.).
Exclusion
Key Trial Info
Start Date :
November 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 18 2021
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04063917
Start Date
November 1 2019
End Date
June 18 2021
Last Update
June 24 2021
Active Locations (2)
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1
University of Calgary, FMC Sleep Centre
Calgary, Alberta, Canada, T2N 4N1
2
Tranq Sleep Centre
Cranbrook, British Columbia, Canada, V1C 3W3