Clinical trial NCT06769607: Evaluation of a Novel Auto-Adjusting Positive Airway Pressure Algorithm for the Treatment of Obstructive Sleep Apnea Clinical Study
Official title: Evaluation of a Novel Auto-Adjusting Positive Airway Pressure Algorithm for the Treatment of Obstructive Sleep Apnea Clinical Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2025-01-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a blind, randomized cross over (or single arm) study aiming to show that the new algorithm is efficacious in the treatment of OSA. Furthermore, it allows for the comparison of relevant objective data parameters from the device and subjective outcomes in comparison to an established algorithm.

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.
Primary purpose: TREATMENT

Brief summary: This study aims to assess the effectiveness of an investigational algorithm in the treatment of obstructive sleep apnea.

Detailed description: This is a blind, randomized cross over (or single arm depending on phase) study aiming to show that the new algorithm is efficacious in the treatment of obstructive sleep apnea (OSA). Furthermore, it allows for the comparison of relevant objective data parameters from the device and subjective outcomes in comparison to an established algorithm.

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.

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.

Eligibility criteria: Inclusion Criteria:

* Participants willing to give written informed consent.
* 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 Bilevel flow generators.
* 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

Primary outcomes:
measure: Comparison of the algorithm efficacy (AHI) to a clinically relevant data
timeFrame: 8 weeks
Secondary outcomes:
measure: Secondary endpoint: Device usage
timeFrame: From enrolment to the end of each study arm (up to 8 weeks)
measure: Secondary endpoint: Leak
timeFrame: From enrollment to the end of each study arm (up to 8 weeks)
measure: Secondary endpoint: Pressure
timeFrame: From enrolment to the end of each study arm (up to 8 weeks)
measure: Secondary endpoint: Subjective scores
timeFrame: From enrolment to the end of each study arm (up to 8 weeks)
Other outcomes:
Locations:
city: Bella Vista
country: Australia
facility: ResMed Ltd
state: New South Wales
Study officials:
References: