Evaluation of a Novel Auto-Adjusting Positive Airway Pressure Algorithm for the Treatment of Obstructive Sleep Apnea Clinical Study

ResMed

Status: Enrolling

Conditions: Obstructive Sleep Apnea

Treatments: Device: Control algorithm; Device: Investigational algorithm

Study type: Interventional

Funder types: Industry

Identifiers

NCT06769607

SLP-24-10-01

Details and patient eligibility

About

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

Full 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. 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Investigational algorithm

Experimental group

Description:

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.

Treatment:

Device: Investigational algorithm

Control algorithm

Active Comparator group

Description:

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.

Treatment:

Device: Control algorithm