Evaluation of a Novel Auto-Adjusting Positive Airway Pressure Algorithm for the Treatment of Obstructive Sleep Apnea Clinical Study
NCT ID: NCT06769607
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2025-04-10
2025-12-31
Brief Summary
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Detailed Description
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This study is planned in two phases. Phase 1 aims to gain confidence that the algorithm is functioning as intended, and allow for minor modifications to be made to the software before proceeding to Phase 2.
Phase 2 aims to assess the performance of the algorithm in a broader range of participants to capture data and subjective feedback comparing the users experience between the new algorithm and the control algorithm.
After the conclusion of phase 1 and 2, an optional extended trial period will be offered to participants who indicate that the experience on the investigational device was satisfactory and would like to continue using the algorithm will be included in an optional extended trial period.
The study will be conducted in the home environment. Participants who met the inclusion/exclusion criteria will be contacted. Participants will be explained the details of the trial and those who wish to take part will be invited to a selected site for the first study visit. In addition, subjects may be asked if they are willing to wear a wearable during both day and night (unless charging) for the duration of the study iteration. The wearable will be a commercially available wellness wearable that collects data to provide information about sleep and activity.
Visit 1 Participants will provide written informed consent. Participants will be set up on the algorithm they are first randomized to. If the participant and assessor are happy to proceed, the participants will take the device home to trial the first randomized algorithm, participants will be asked to complete a questionnaire regarding their therapy experience.
Visit 2 Participants will then be switched to the alternative algorithm and take the study device home to test. After trialling the second algorithm, participants will be asked to complete a questionnaire regarding their therapy experience and overall preferences.
Note: Visit 2 is not required if a cross over is not required in Phase 1.
Visit 3 The participant will return the investigational device to the assessor. The participants' questionnaire responses will be reviewed. Participants will be reimbursed. This concludes the participation in the study.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
The study is planned in two phases. Phases may be repeated until sufficient confidence is gained of the intended behavior of the investigational algorithm and to ensure that the sample has appropriate coverage of different user experiences which can impact study outcomes (e.g. comfort settings such as soft response).
After the conclusion of phase 1 and 2, participants who indicate that the experience on the investigational device was satisfactory and would like to continue using the algorithm will be included in an optional extended trial period.
TREATMENT
SINGLE
Study Groups
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Investigational algorithm
The participants will trial the investigational algorithm and the control algorithm in a randomized order. Each will be used for up to 4 weeks in the home environment in place of their own device/therapy. The study device will be set up to align with the majority of the participants current therapy settings.
Investigational algorithm
Investigational algorithm developed for the treatment of Obstructive Sleep Apnea.
Control algorithm
The participants will trial the investigational algorithm and the control algorithm in a randomized order. Each will be used for up to 4 weeks in the home environment in place of their own device/therapy. The study device will be set up to align with the majority of the participants current therapy settings.
Control algorithm
Released algorithm intended for the treament of Obstructive Sleep Apnea
Interventions
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Investigational algorithm
Investigational algorithm developed for the treatment of Obstructive Sleep Apnea.
Control algorithm
Released algorithm intended for the treament of Obstructive Sleep Apnea
Eligibility Criteria
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Inclusion Criteria
* Participants who can read and comprehend English.
* Participants who ≥ 18 years of age
* Participants who have been using a ResMed AirSense 10 or 11 device.
* Participants currently using AutoSet (APAP) mode.
* Participants being established on PAP therapy for the treatment of OSA for approximately \>3 months.
* Participants who can participate in the study for up to 8 weeks.
Exclusion Criteria
* Participants using CPAP, AutoSet for Her
* Participants who are or may be pregnant.
* Participants with a preexisting lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection; lung injury.
* Participants believed to be unsuitable for inclusion by the researcher.
* Participants who are currently enrolled in other medical clinical studies
18 Years
ALL
No
Sponsors
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ResMed
INDUSTRY
Responsible Party
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Locations
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ResMed Ltd
Bella Vista, New South Wales, Australia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SLP-24-10-01
Identifier Type: -
Identifier Source: org_study_id
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