NCT05376137

Brief Summary

350 participants will be enrolled in this study. The target population are patients newly diagnosed with OSA and starting CPAP treatment. User accessible customizable comfort settings (Response setting, expiratory pressure relief (EPR) on/off and EPR level, and Ramp) will be set to either default (control group), or personalized for that participant (active treatment group). Usage will be recorded for the first 1 month of CPAP treatment, to determine if customizing comfort settings can improve CPAP compliance

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 17, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

September 15, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

10 months

First QC Date

May 11, 2022

Last Update Submit

November 17, 2023

Conditions

Obstructive Sleep Apnea

Keywords

Continuous Positive Airway Pressure

Outcome Measures

Primary Outcomes (1)

  • Comparison of treatment continuance between the control group and active treatment group.

    Patients who drop off treatment (stop using CPAP treatment) in each group will be compared after 1.5 months of CPAP treatment.

    4 weeks after commencement of CPAP

Secondary Outcomes (5)

  • comparison of compliance between the control group and active treatment group

    4 weeks after commencement of CPAP

  • Treatment efficacy

    4 weeks after commencement of CPAP

  • Mask leak

    4 weeks after commencement of CPAP

  • Settings changes

    4 weeks after commencement of CPAP

  • Ad hoc contacts

    4 weeks after commencement of CPAP

Other Outcomes (1)

  • Exploratory analysis of long term usage

    3,6,9, 12 months after commencement of CPAP

Study Arms (2)

Default comfort settings

ACTIVE COMPARATOR

Comfort settings will be set to default (out of the box setttings)

Device: continuous positive airway pressure (CPAP)

Personalized Therapy Comfort Settings

EXPERIMENTAL

Comfort settings will be personalized to each user

Device: continuous positive airway pressure (CPAP)

Interventions

continuous positive airway pressure (CPAP)DEVICE

CPAP comfort settings will be modified in the active group to be personalized to each participant

Default comfort settingsPersonalized Therapy Comfort Settings

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients willing to give written informed consent
  • Patients who can read and comprehend English
  • Patients who are ≥ 18 years of age
  • Patients newly diagnosed with OSA and indicated for CPAP therapy.

You may not qualify if:

  • Patients who have previously used PAP therapy
  • Patients who require a bilevel device
  • Patients who are or may be pregnant
  • \* Patients who are unable to attend follow up appointments
  • Patients 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ResMed Centre for Healthy Sleep

Bella Vista, New South Wales, 2153, Australia

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Jeff Armitstead, PhD

    ResMed

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2022

First Posted

May 17, 2022

Study Start

September 15, 2022

Primary Completion

June 30, 2023

Study Completion

September 13, 2023

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)