Validation of Safety and Performance of Three EDDIS Breath-Activated Portable Inhalation Systems

N/ANot Yet RecruitingNCT06902129

Petrov, Andrey10 enrolled

Overview

This is a crossover study to evaluate real-time performance, airflow control, user-device interaction, and safety systems of three portable inhalation systems from the EDDIS platform. The formulation is non-pharmacological and inert. Each volunteer will use all three devices in random order. Primary endpoints focus on gas dynamics, inhalation recording accuracy, device integrity, and user tolerability.

This is a device-only evaluation of three portable inhalation delivery systems from the EDDIS platform (VMT, Atomizer, Ultrasonic). The study focuses on technical performance, gas dynamics, safety system integrity, and user-device interaction under controlled conditions in healthy adult volunteers. Each device is breath-actuated, disposable, and digitally integrated with a smartphone application. The inhaled formulation consists of sterile 0.9% sodium chloride containing suspended chitosan nanoparticles (\<200 nm), designed to simulate complex aerosol behavior without delivering any active pharmaceutical ingredients. The study employs a crossover design, allowing each subject to evaluate all three devices in a randomized sequence. Performance characteristics such as airflow resistance, aerosol output, inspiratory detection sensitivity, power consumption, and digital logging accuracy will be assessed. Special emphasis is placed on safety-related engineering features, including detection of abnormal inhalation patterns (e.g., cough-like events), child-lock functionality, and plume behavior under variable user conditions. This study does not involve any drug or therapeutic intervention, is not classified as a clinical investigation under EU MDR or Swissmedic regulations, and does not require ethics committee oversight. The primary objective is to validate the EDDIS platform as a modular, scalable, and precisely controlled aerosol delivery system suitable for further development in both clinical and non-clinical applications.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Interventions

EDDIS Platform - Portable Inhalation Delivery Systems (VMT, Atomizer, Ultrasonic)DEVICE

A set of three single-use, disposable, closely matched and uniform in size, breath-actuated, digitally monitored portable inhalation devices designed for precision aerosol delivery. Devices include a vibrating mesh (VMT), an atomizer-based unit (ATM), and an ultrasonic micro-vibration unit (ULT). Each system records inhalation parameters and connects via Bluetooth to a mobile application for real-time feedback and logging. Used to assess technical performance, gas dynamics, and digital control functions using a non-active NaCl-based aerosol with chitosan nanoparticles.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Age between 21 and 75 years * Generally healthy adult (no known systemic or chr * Normal pulmonary function (FEV1 ≥ 80% predicted at screening) * Body Mass Index (BMI) between 18.5 and 30 kg/m² * Able and willing to provide written informed consent form * Current or prior use of tabac Exclusion Criteria: * Body temperature ≥ 38.0°C on the day of screening or inhalation * Acute respiratory infection, cough, cold, or any inflammatory disease of the head and neck within the last 2 weeks * History of asthma, COPD, or other chronic pulmonary disease * History of thoracic or lung surgery * Known cardiovascular pathology, including uncontrolled or progressive hypertension * Pulmonary bleeding, hemoptysis, or blood in saliva * Diagnosed emphysema * Known bleeding disorders or use of anticoagulants * Known allergy or hypersensitivity to chitosan or related compounds * Any inhalation-induced adverse reactions during baseline assessment (e.g., cough reflex not resolving within 30 seconds) * Use of investigational drugs or participation in another clinical study within 30 days prior to enrollment * Unwillingness or inability to follow the study plan or to comply with the requirements of the informed consent agreement * Any condition which, in the opinion of the investigator, may interfere with study participation or result interpretation

Outcomes

Primary Outcomes

Airflow Resistance Measurement

change in airflow resistance (cmH₂O/L/s) across three devices (cmH₂O/L/s via digital sensor output)

Time frame: up to 72 hours

Inspiratory Flow Detection Accuracy

quantitative indicators (%) of detection of valid inhalation efforts compared to reference pneumotachograph

Time frame: up to 72 hours

Secondary Outcomes

Device Recording Fidelity

rate of accurate digital logging of breath events ( accuracy vs manually annotated data) %)

Time frame: up to 6 hours (during all sessions)

Subjective Device Comfort Score

self-reported comfort level assessed immediately after using each device, using a standardized 10-point Visual Analog Scale (VAS), where 0 represents "very uncomfortable" and 10 represents "extremely comfortable"

Time frame: up to 6 hours (after each device use - 3 total sessions)

Safety Event Detection

The number of abnormal inspiratory events detected per device, including simulated coughs, breath holding, or irregular inspiratory flow patterns. Events are automatically logged by the digital security system and manually reviewed

Time frame: up to 3 hours (during each inhalation session per device)