PAP-NAP Device Clinical Study
ConditionObstructive Sleep Apnea
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorResMed
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
APL Device
DeviceThe investigational intervention is a prototype novel positive airway pressure (PAP) device for the treatment of obstructive sleep apnea (OSA). Participants will use the device during a supervised daytime nap session in a simulated bedroom environment to evaluate usability and short-term tolerability, including comfort, seal, ease of use, and ability to initiate sleep.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: APL Wearable PAP DeviceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
1
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)2
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)3
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.
Time frame
During the supervised daytime PAP-NAP session (up to 90 minutes)Locations
Source ClinicalTrials.gov
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