PAP-NAP Device Clinical Study

N/ANot Yet RecruitingNCT07785310

ResMed10 enrolled

Overview

This exploratory pilot study will evaluate the usability and short-term tolerability of a novel positive airway pressure (PAP) device in adults during a supervised daytime nap session in a simulated sleep environment. The study is designed to assess participant experience with the investigational PAP device, including comfort, fit and seal, ease of use, and ability to fall asleep while using the device. Participants will attend a supervised PAP-Nap session where they will use the PAP device while resting or attempting to sleep. Study staff will also observe sleep-related behaviours, including sleep onset and session completion. Information collected from this study will help inform future development and refinement of wearable PAP technologies intended for the treatment of obstructive sleep apnea (OSA).

This exploratory pilot clinical investigation is designed to evaluate the usability and short-term tolerability of the investigational positive airway pressure (PAP) device during a supervised daytime nap session in adults with obstructive sleep apnea (OSA) who are established continuous positive airway pressure (CPAP) users. The study focuses on early-stage human factors and usability assessment to support iterative device development and future clinical investigation planning. Approximately 10-15 adult participants with diagnosed OSA who are currently using CPAP therapy will attend a single supervised in-clinic visit in a simulated bedroom environment. Participants will undergo device fitting and instruction before attempting a daytime nap of up to 90 minutes using the investigational device. During the session, trained study personnel will monitor participant safety and device performance through direct and/or remote observation. The primary evaluation focuses on participant-reported usability outcomes, including comfort, seal, perceived weight, and ease of use. Secondary and exploratory assessments include ability to initiate sleep while using the device, observed sleep-related behaviours, session completion, tolerability, and descriptive sleep-related data collected from a contactless under-mattress monitoring device. Data collected from this study are intended to support design refinement, usability optimisation, and planning of future clinical studies involving wearable PAP technologies.

Study Type

INTERVENTIONAL

Allocation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Willing and able to provide written informed consent * Able to read and comprehend English * Aged 18 years or older * Currently using continuous positive airway pressure (CPAP) therapy for at least 3 months for treatment of obstructive sleep apnea (OSA) * Using CPAP mode with a fixed therapeutic pressure less than 16 cmH2O * Current user of a nasal mask interface and appropriately fitted to a medium-sized nasal mask * Agree to supervised monitoring, including video observation, during the nap session * Willing and able to attend a single in-clinic visit and attempt a supervised daytime nap of up to 90 minutes using the investigational device Exclusion Criteria: * Current use of bilevel positive airway pressure devices * Pregnant or possibly pregnant * Pre-existing lung disease or condition that may predispose to pneumothorax (e.g., chronic obstructive pulmonary disease \[COPD\], lung cancer, pulmonary fibrosis, recent pneumonia or lung infection within the past 2 years, or lung injury) * Active implanted medical devices that may interact with magnets, including pacemakers, implantable cardioverter defibrillators (ICDs), neurostimulators, cerebrospinal fluid shunts, or infusion pumps * Any condition or circumstance that, in the opinion of the investigator, could make participation unsafe or interfere with interpretation of study results * Currently enrolled in another clinical study

Outcomes

Primary Outcomes

Feasibility and Usability of the Investigational PAP Device During a Supervised Daytime PAP-NAP Session

Participant-reported feasibility and usability of the investigational APL PAP device during a supervised daytime PAP-NAP session, assessed using an 11-point Likert scale (0-10) across predefined device-related domains including comfort, mask seal, stability, and ease of use/application.

Time frame: Immediately following the supervised daytime nap session (single study visit; up to 3 hours)

Secondary Outcomes

Number of Participants Achieving Observed Sleep Onset During the Supervised PAP-NAP Session

Number of participants observed by trained study personnel to achieve sleep onset during the supervised daytime PAP-NAP session while using the investigational device, based on predefined observational criteria.

Time frame: During the supervised daytime PAP-NAP session (up to 90 minutes)

Number of Participants Completing the Supervised PAP-NAP Session

Number of participants who successfully complete the supervised daytime PAP-NAP session while using the investigational APL PAP device.

Time frame: During and immediately following the supervised daytime nap session (up to 90 minutes)

Number of Participants With Early Session Termination Due to Device Intolerance

Number of participants who prematurely terminate the supervised daytime PAP-NAP session due to device-related intolerance, discomfort, or other tolerability-related issues.