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Personal Therapy Comfort Settings Pilot Clinical Study

Primary Purpose

Obstructive Sleep Apnea

Status
Recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
continuous positive airway pressure (CPAP)
Sponsored by
ResMed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Continuous Positive Airway Pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • Patients believed to be unsuitable for inclusion by the researcher

Sites / Locations

  • ResMed Centre for Healthy SleepRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Default comfort settings

Personalized Therapy Comfort Settings

Arm Description

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

Comfort settings will be personalized to each user

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

comparison of compliance between the control group and active treatment group
Usage will be compared between the two groups
Treatment efficacy
Residual Apnea-hypopnea index will be compared between the two groups
Mask leak
Mask leak will be compared between the two groups
Settings changes
Number of comfort settings changes will be compared between the two groups
Ad hoc contacts
Number of ad hoc contacts between participants and clinicians will be compared between the two groups

Full Information

First Posted
May 11, 2022
Last Updated
July 23, 2023
Sponsor
ResMed
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1. Study Identification

Unique Protocol Identification Number
NCT05376137
Brief Title
Personal Therapy Comfort Settings Pilot Clinical Study
Official Title
Personal Therapy Comfort Settings Pilot Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
September 20, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ResMed

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Continuous Positive Airway Pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Default comfort settings
Arm Type
Active Comparator
Arm Description
Comfort settings will be set to default (out of the box setttings)
Arm Title
Personalized Therapy Comfort Settings
Arm Type
Experimental
Arm Description
Comfort settings will be personalized to each user
Intervention Type
Device
Intervention Name(s)
continuous positive airway pressure (CPAP)
Intervention Description
CPAP comfort settings will be modified in the active group to be personalized to each participant
Primary Outcome Measure Information:
Title
Comparison of treatment continuance between the control group and active treatment group.
Description
Patients who drop off treatment (stop using CPAP treatment) in each group will be compared after 1.5 months of CPAP treatment.
Time Frame
4 weeks after commencement of CPAP
Secondary Outcome Measure Information:
Title
comparison of compliance between the control group and active treatment group
Description
Usage will be compared between the two groups
Time Frame
4 weeks after commencement of CPAP
Title
Treatment efficacy
Description
Residual Apnea-hypopnea index will be compared between the two groups
Time Frame
4 weeks after commencement of CPAP
Title
Mask leak
Description
Mask leak will be compared between the two groups
Time Frame
4 weeks after commencement of CPAP
Title
Settings changes
Description
Number of comfort settings changes will be compared between the two groups
Time Frame
4 weeks after commencement of CPAP
Title
Ad hoc contacts
Description
Number of ad hoc contacts between participants and clinicians will be compared between the two groups
Time Frame
4 weeks after commencement of CPAP
Other Pre-specified Outcome Measures:
Title
Exploratory analysis of long term usage
Description
CPAP usage will be compared at 3, 6, 9 and 12 months for patients who have consented, as an exploratory analysis of long term usage
Time Frame
3,6,9, 12 months after commencement of CPAP

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 Patients believed to be unsuitable for inclusion by the researcher
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alison Wimms, PhD
Phone
+61466015420
Email
alison.wimms@resmed.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Armitstead, PhD
Organizational Affiliation
ResMed
Official's Role
Principal Investigator
Facility Information:
Facility Name
ResMed Centre for Healthy Sleep
City
Bella Vista
State/Province
New South Wales
ZIP/Postal Code
2153
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alison Wimms, BSc
Phone
02 8884 1123
Email
alison.wimms@resmed.com.au

12. IPD Sharing Statement

Plan to Share IPD
No

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Personal Therapy Comfort Settings Pilot Clinical Study

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