Obstructive Sleep Apnea (OSA)NCT04744038
Evaluating the Efficacy of PAP Therapy for Treating OSA in the Home Environment
A study testing Positive Airway Pressure (PAP) Therapy in people with Obstructive Sleep Apnea (OSA), run by ResMed at 2 sites in 2 countries.
Trial summary
This study will take between 4-6 months (with first patient first visit to last patient last visit expected to span 3-4 months across all study sites). Each participant will use the investigational PAP device with their own mask for a period of up to 7 nights and will complete a series of questionnaires upon… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea (OSA)
- What is being tested?
- Positive Airway Pressure (PAP) Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 12 Aug 2020to 5 Mar 2021
- 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
- Healthy volunteers accepted
- 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 ≥ 18 years of age
- Patients being established on PAP therapy for the treatment of OSA for ≥ 6 months
- Patients currently using AirSense10 (as their primary device)
- Patients currently using an appropriate mask system (AirFit F20, AirFit P10, AirFit N20, AirFit N30i, AirFit F30i or AirFit P30i)
- Patients who can trial the investigational device for up to 7 nights
- Patients who have been compliant to therapy (average of ≥4 hours of usage) for the previous 7 nights of use* *the most recent consecutive 7 nights within the last 30 days
Who cannot join
- Patients using Bilevel flow generators
- 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
- Patients who or whose bed partner has implantable metallic implants in the head, neck and chest region affected by magnetic fields (Non-ferrous implants may be acceptable)
- Patients using supplemental oxygen
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Evaluating the Efficacy of Positive Airway Pressure Therapy for Treating Obstructive Sleep Apnea in the Home Environment
This study will take between 4-6 months (with first patient first visit to last patient last visit expected to span 3-4 months across all study sites). Each participant will use the investigational PAP device with their own mask for a period of up to 7 nights and will complete a series of questionnaires upon completion. The study will evaluate the usability and efficacy of the investigational device in the intended use environment by the intended use population.
Read the detailed description
A new PAP device has been developed by ResMed which includes an improved humidification system, a new user interface and optimized workflows. This study will assess the efficacy and usability of the new PAP device in an OSA population.
This is a prospective, open-label, single arm study, multi-site study to assess the usability and efficacy of investigational device in the home environment.
Recruitment Recruitment will be done via phone calls/ SMS messages/ emails. Participants will be explained the details of the study and those who wish to take part will be invited to a ResMed clinic or selected site for the first study visit (As detailed in section 7).
Visit 1 Participants will provide written informed consent (as per section 6.1). If eligible, baseline participant demographics will be collected. Participants will be shown the investigation device. If the participant is happy to proceed the investigational device will be set-up to be exactly the same as their current CPAP device, and the participant will take it home to use in place of their own device.
Visit 2 At the conclusion of the 7 nights of use, the participant will be asked to fill in a questionnaire documenting their experience with the investigational device. The participant will return all study equipment to the researcher. The questionnaires will be reviewed. This concludes the participation in the study.
- Conditions
- Obstructive Sleep Apnea (OSA)
- Being tested
- Positive Airway Pressure (PAP) Therapy
- 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.
Positive Airway Pressure (PAP) TherapyDevice
PAP therapy supplies pressurized air from the flow generator to the upper airway via air tubing and a mask to prevent the repetitive collapse of the upper airway during sleep.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Device | Experimental | Participants will then be asked to take home the investigational device to use at night while they sleep in place of their own device. The participant's therapy and comfort settings will be copied from their own device to the investigational device. Participants will use their own mask with the investigational device for the duration of this study. Receives: Device: Positive Airway Pressure (PAP) Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability
Subjective ratings of the Usability of the Pacific device after using it in the home environment for up to 7 nights. Ratings will be collected using an 11 point Likert Scale where a score of 10 is considered very favorable, and a score of 0 is very unfavorable.
Measured: 1 week
Secondary outcomes (5)
Apnea Hypopnea Index (AHI)
Number of residual Apnea Hypopnea events within a clinically acceptable range when using the Pacific device in the home environment for a up to 7 nights.
Measured: 1 week
Usage-Positive Airway Pressure (PAP) Device parameters
Average number of hours per night of use of the Pacific Device during sleep sessions from up to 7 nights
Measured: 1 week
Leak-Positive Airway Pressure (PAP) Device parameters
Average median, 95 percentile and maximum leak(L/min) while using the Pacific device from up to 7 nights
Measured: 1 week
Pressure-Positive Airway Pressure (PAP) Device parameters
Average pressure delivered by the Pacific device between 4cmH2O-20cmH2O from use up to 7 nights
Measured: 1 week
Acoustic Signals
Cross-correlation of the acoustic signals recorded from the patient environment and the external recording in the controlled laboratory environment identification algorithm.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start12 Aug 2020
- Primary completion5 Mar 2021
- Study completion5 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSA)Studies of the same condition, open and under way.
- More trials run by ResMedThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04744038
- Sponsor's protocol ID
- SLP-20-01-01
- Status last verified
- Feb 2021
- First submitted
- 4 Jan 2021
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Positive Airway Pressure Therapy for Treating Obstructive Sleep Apnea in the Home Environment
- ClinicalTrials.gov ID
- NCT04744038
- Acronym / sponsor ID
- SLP-20-01-01
- Conditions
- Obstructive Sleep Apnea (OSA)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2020 (actual)
- Primary completion
- 5 Mar 2021 (actual)
- Study completion
- 5 Mar 2021 (actual)
- First posted
- 8 Feb 2021 (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.
This study will take between 4-6 months (with first patient first visit to last patient last visit expected to span 3-4 months across all study sites). Each participant will use the investigational PAP device with their own mask for a period of up to 7 nights and will complete a series of questionnaires upon completion. The study will evaluate the usability and efficacy of the investigational device in the intended use environment by the intended use population.
Detailed description
A new PAP device has been developed by ResMed which includes an improved humidification system, a new user interface and optimized workflows. This study will assess the efficacy and usability of the new PAP device in an OSA population.
This is a prospective, open-label, single arm study, multi-site study to assess the usability and efficacy of investigational device in the home environment.
Recruitment Recruitment will be done via phone calls/ SMS messages/ emails. Participants will be explained the details of the study and those who wish to take part will be invited to a ResMed clinic or selected site for the first study visit (As detailed in section 7).
Visit 1 Participants will provide written informed consent (as per section 6.1). If eligible, baseline participant demographics will be collected. Participants will be shown the investigation device. If the participant is happy to proceed the investigational device will be set-up to be exactly the same as their current CPAP device, and the participant will take it home to use in place of their own device.
Visit 2 At the conclusion of the 7 nights of use, the participant will be asked to fill in a questionnaire documenting their experience with the investigational device. The participant will return all study equipment to the researcher. The questionnaires will be reviewed. This concludes the participation in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational Device | Experimental | Device: Positive Airway Pressure (PAP) TherapyParticipants will then be asked to take home the investigational device to use at night while they sleep in place of their own device. The participant's therapy and comfort settings will be copied from their own device to the investigational device. Participants will use their own mask with the investigational device for the duration of this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients willing to give written informed consent
- Patients who can read and comprehend English
- Patients who ≥ 18 years of age
- Patients being established on PAP therapy for the treatment of OSA for ≥ 6 months
- Patients currently using AirSense10 (as their primary device)
Key exclusion criteria (6 listed)
- Patients using Bilevel flow generators
- 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
- Patients who or whose bed partner has implantable metallic implants in the head, neck and chest region affected by magnetic fields (Non-ferrous implants may be acceptable)
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 |
|---|---|---|
| Positive Airway Pressure (PAP) TherapyPAP therapy supplies pressurized air from the flow generator to the upper airway via air tubing and a mask to prevent the repetitive collapse of the upper airway during sleep. | Device | Investigational Device |
Primary outcome
Usability
Time frame: 1 week
Subjective ratings of the Usability of the Pacific device after using it in the home environment for up to 7 nights. Ratings will be collected using an 11 point Likert Scale where a score of 10 is considered very favorable, and a score of 0 is very unfavorable.
5 secondary outcomes
Apnea Hypopnea Index (AHI)
Time frame: 1 week
Usage-Positive Airway Pressure (PAP) Device parameters
Time frame: 1 week
Leak-Positive Airway Pressure (PAP) Device parameters
Time frame: 1 week
Pressure-Positive Airway Pressure (PAP) Device parameters
Time frame: 1 week
Acoustic Signals
Time frame: 1 week
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 13 Jul 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Airway Pressure (PAP) Therapy in people with Obstructive Sleep Apnea (OSA), run by ResMed at 2 sites in 2 countries.
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 8 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 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, 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?
Usability (time frame: 1 week). 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 13 Jul 2021.