Safety, and Tolerability of the ZENS Device (PLUTO)

NCT04063917 | Completed DMC

• 1 other identifier: CIP-001
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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. 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).

Conditions

Snoring; Obstructive Sleep Apnea

Keywords

Sleep Apnea; Snoring

Outcome Measures

Primary Outcomes (1)

• Percent change in loud snoring time

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

  up to 5 hours

Secondary Outcomes (5)

• Change in AHI

  up to 5 hours

• Percentage difference of time (minutes) per hour of sleep with loud snoring

  up to 5 hours

• Change in the number of arousals and awakenings in the "ON" versus "OFF" phase

  up to 5 hours

• Difference in the mean oxygen saturation levels

  up to 5 hours

• Number of patients with successful snoring reduction

  up to 5 hours

Other Outcomes (3)

• Incidence of adverse events, serious adverse events, device deficiencies and unanticipated adverse device effects

  up to 96 hours

• Percent of the time the ZENS Device was adhered to the participant

  up to 12 hours

• Tolerability of the ZENS Device

  up to 12 hours

Study Arms (2)

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.

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

Device: ZENS

Interventions

ZENS DEVICE

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.

Sequence 1; Sequence 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zennea Technologies Inc.: lead
• University of Calgary: collaborator
• Interior Health: collaborator

Study Sites (2)

University of Calgary, FMC Sleep Centre

Calgary, Alberta, T2N 4N1, Canada

Location

Tranq Sleep Centre

Cranbrook, British Columbia, V1C 3W3, Canada

Location

Related Links

• Zennea Technologies website

MeSH Terms

Conditions

Snoring; Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Marcus Povitz, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 21, 2019
• Study Start: November 1, 2019
• Primary Completion: April 1, 2021
• Study Completion: June 18, 2021
• Last Updated: June 24, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)