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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05376137




Registration number
NCT05376137
Ethics application status
Date submitted
11/05/2022
Date registered
17/05/2022
Date last updated
18/11/2023

Titles & IDs
Public title
Personal Therapy Comfort Settings Pilot Clinical Study
Scientific title
Personal Therapy Comfort Settings Pilot Clinical Study
Secondary ID [1] 0 0
MA11022022
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - continuous positive airway pressure (CPAP)

Active Comparator: Default comfort settings - Comfort settings will be set to default (out of the box setttings)

Experimental: Personalized Therapy Comfort Settings - Comfort settings will be personalized to each user


Treatment: Devices: continuous positive airway pressure (CPAP)
CPAP comfort settings will be modified in the active group to be personalized to each participant
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Comparison of treatment continuance between the control group and active treatment group.
Timepoint [1] 0 0
4 weeks after commencement of CPAP
Secondary outcome [1] 0 0
comparison of compliance between the control group and active treatment group
Timepoint [1] 0 0
4 weeks after commencement of CPAP
Secondary outcome [2] 0 0
Treatment efficacy
Timepoint [2] 0 0
4 weeks after commencement of CPAP
Secondary outcome [3] 0 0
Mask leak
Timepoint [3] 0 0
4 weeks after commencement of CPAP
Secondary outcome [4] 0 0
Settings changes
Timepoint [4] 0 0
4 weeks after commencement of CPAP
Secondary outcome [5] 0 0
Ad hoc contacts
Timepoint [5] 0 0
4 weeks after commencement of CPAP

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/09/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/09/2023
Sample size
Target
Accrual to date
Final
66
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
ResMed Centre for Healthy Sleep - Bella Vista
Recruitment postcode(s) [1] 0 0
2153 - Bella Vista

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ResMed
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT05376137
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jeff Armitstead, PhD
Address 0 0
ResMed
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries