Obstructive Sleep ApneaNCT05376137
Personal Therapy Comfort Settings Pilot Clinical Study
A study testing continuous positive airway pressure (CPAP) in people with Obstructive Sleep Apnea, run by ResMed at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- continuous positive airway pressure (CPAP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteAustralia
- Study dates
- 15 Sep 2022to 13 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
ResMed Centre for Healthy Sleep
Bella Vista, New South Wales, 2153
About this study
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
- Conditions
- Obstructive Sleep Apnea
- Being tested
- continuous positive airway pressure (CPAP)
- Keywords
- Continuous Positive Airway Pressure
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous positive airway pressure (CPAP)Device
CPAP comfort settings will be modified in the active group to be personalized to each participant
| Study group | Role | What they receive |
|---|---|---|
| Default comfort settings | Active comparator | Comfort settings will be set to default (out of the box setttings) Receives: Device: continuous positive airway pressure (CPAP) |
| Personalized Therapy Comfort Settings | Experimental | Comfort settings will be personalized to each user Receives: Device: continuous positive airway pressure (CPAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks after commencement of CPAP
Secondary outcomes (5)
comparison of compliance between the control group and active treatment group
Usage will be compared between the two groups
Measured: 4 weeks after commencement of CPAP
Treatment efficacy
Residual Apnea-hypopnea index will be compared between the two groups
Measured: 4 weeks after commencement of CPAP
Mask leak
Mask leak will be compared between the two groups
Measured: 4 weeks after commencement of CPAP
Settings changes
Number of comfort settings changes will be compared between the two groups
Measured: 4 weeks after commencement of CPAP
Ad hoc contacts
Number of ad hoc contacts between participants and clinicians will be compared between the two groups
Measured: 4 weeks after commencement of CPAP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start15 Sep 2022
- Primary completion30 Jun 2023
- Study completion13 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeff Armitstead, PhD, Principal investigator, ResMed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05376137
- Sponsor's protocol ID
- MA11022022
- Status last verified
- Nov 2023
- First submitted
- 11 May 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personal Therapy Comfort Settings Pilot Clinical Study
- ClinicalTrials.gov ID
- NCT05376137
- Acronym / sponsor ID
- MA11022022
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Continuous Positive Airway Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 13 Sep 2023 (actual)
- First posted
- 17 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Default comfort settings | Active comparator | Device: continuous positive airway pressure (CPAP)Comfort settings will be set to default (out of the box setttings) |
| Personalized Therapy Comfort Settings | Experimental | Device: continuous positive airway pressure (CPAP)Comfort settings will be personalized to each user |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- Patients who have previously used PAP therapy
- Patients who require a bilevel device
- Patients who are or may be pregnant
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| continuous positive airway pressure (CPAP)CPAP comfort settings will be modified in the active group to be personalized to each participant | Device | Default comfort settings, Personalized Therapy Comfort Settings |
Primary outcome
Comparison of treatment continuance between the control group and active treatment group.
Time frame: 4 weeks after commencement of CPAP
Patients who drop off treatment (stop using CPAP treatment) in each group will be compared after 1.5 months of CPAP treatment.
5 secondary outcomes
comparison of compliance between the control group and active treatment group
Time frame: 4 weeks after commencement of CPAP
Treatment efficacy
Time frame: 4 weeks after commencement of CPAP
Mask leak
Time frame: 4 weeks after commencement of CPAP
Settings changes
Time frame: 4 weeks after commencement of CPAP
Ad hoc contacts
Time frame: 4 weeks after commencement of CPAP
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Obstructive Sleep Apnea
Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression
Not yet recruiting
Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions
Hypoxemia, Gastric Cancer (Diagnosis)
RecruitingObservational study
Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
Pediatric Obstructive Sleep Apnea
Enrolling by invitation
Myofunctional Therapy for Obstructive Sleep Apnea
Obstructive Sleep Apnea
Recruiting
Physical Activity, Sleep Quality, and Respiratory Function in Obstructive Sleep Apnea
Obstructive Sleep Apnea, Sleep Quality
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeff Armitstead, PhD principal investigator
ResMed
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing continuous positive airway pressure (CPAP) in people with Obstructive Sleep Apnea, run by ResMed at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of treatment continuance between the control group and active treatment group. (time frame: 4 weeks after commencement of CPAP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.