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

NCT06769607 | Recruiting

• 1 other identifier: SLP-24-10-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Comparison of the algorithm efficacy (AHI) to a clinically relevant data

  The mean residual AHI of the investigational algorithm will be compared against an excepted clinical benchmark of 5 using a one sample t test.

  8 weeks

Secondary Outcomes (6)

• Secondary endpoint: Device usage

  From enrolment to the end of each study arm (up to 8 weeks)

• Secondary endpoint: Leak

  From enrollment to the end of each study arm (up to 8 weeks)

• Secondary endpoint: Pressure

  From enrolment to the end of each study arm (up to 8 weeks)

• Secondary endpoint: Subjective scores

  From enrolment to the end of each study arm (up to 8 weeks)

• Wearable data - Sleep metrics

  From enrolment to the end of each study arm (up to 8 weeks)

Study Arms (2)

Investigational algorithm

EXPERIMENTAL

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.

Device: Investigational algorithm

Control algorithm

ACTIVE COMPARATOR

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.

Device: Control algorithm

Interventions

Investigational algorithm DEVICE

Investigational algorithm developed for the treatment of Obstructive Sleep Apnea.

Investigational algorithm

Control algorithm DEVICE

Released algorithm intended for the treament of Obstructive Sleep Apnea

Control algorithm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 who are currently enrolled in other medical clinical studies

Sponsors & Collaborators

• ResMed: lead

Study Sites (1)

ResMed Ltd

Bella Vista, New South Wales, 2153, Australia

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Sumudu Herath

CONTACT

+61 288841722; sumudu.herath@resmed.com.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single (Participant)
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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, wearable data 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.

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: January 10, 2025
• Study Start: April 10, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)