Sleep Disorder; Breathing-RelatedNCT03948152
A Study to Determine Preferences Towards Interface Products
A study testing Mask Advice Tool in people with Sleep Disorder; Breathing-Related, run by Philips Respironics at 5 sites in United States.
Trial summary
Enrolled Naïve participants will be randomized to one of two arms, the investigational or control arm. Once randomized the institutions will fit the participant with the procedures outlined in the protocol. Each participant will be required to trial the mask for a period of 90 days. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Sleep Disorder; Breathing-Related
- What is being tested?
- Mask Advice Tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 5 sitesUnited States
- Study dates
- 18 Apr 2019to 7 Feb 2020
- 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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult Volunteers (ages 21-85)
- Willing and able to provide informed consent
- Able to follow instructions
- Able to read and speak in English as their primary language
- Currently diagnosed with Sleep Apnea through an in-lab sleep (polysomnography (PSG)) or home sleep testing, but has not started therapy and/or been fit with a mask.
Who cannot join
- Pre-existing conditions such as bullous lung disease, pathologically low blood pressure, bypassed upper airway, pneumothorax, pneumocephalus, cerebral spinal fluid (CSF) leaks, cribriform plate abnormalities, and prior history of head trauma that has resulted in current cognitive dysfunction.
- Prescribed an Adaptive Servo Ventilation (ASV) device
- The presence of physical or mental limitations that would limit the ability to test the mask.
- Obstructive Sleep Apnea (OSA) diagnosis achieved through a split night sleep study
- Known allergy to silicone
- Unique facial features (i.e. deformities of the face and/or head, piercings, etc) that could interfere with the use of masks.
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- Employee of Philips or spouse of a Philips employee
- Currently participating in another interventional research study or planned participation in another interventional research study during the trial period (by self-report)
- Surgery involving the eyes, ears, nose, sinuses, or upper airway within the last 90 days.
- Planned surgical procedures involving the head, neck, face (eyes, ears, nose), or lung during the trial period.
- Uncontrolled or poorly managed gastroesophageal reflux
- Impaired cough reflex
- Untreated or symptomatic hiatal hernia
- Untreated glaucoma
- Untreated chronic dry eyes
- Unable to remove the sleep apnea mask without the assistance of others
- Use of prescription drugs that induce vomiting
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Center for Sleep and Wake Disorders
Chevy Chase, Maryland, 20815
Bogan Sleep Consultants, LLC
Columbia, South Carolina, 29201
Pulmonary Disease Specialists, PA, d/b/a PDS Research
Kissimmee, Florida, 34741
Berks Schuylkill Respiratory Specialists, Ltd.
Reading, Pennsylvania, 19610
Pullmonary Rehabilition Associates
Youngstown, Ohio, 44512
About this study
Official title: A Study to Determine Clinician and Patient Preferences Towards Interface Products Recommended by the 3D Mask Advice Tool
Enrolled Naïve participants will be randomized to one of two arms, the investigational or control arm. Once randomized the institutions will fit the participant with the procedures outlined in the protocol. Each participant will be required to trial the mask for a period of 90 days. Any Unscheduled Visits or Calls that occur during the participants 90 days documented.
- Conditions
- Sleep Disorder; Breathing-Related
- Being tested
- Standard of Care, Mask Advice Tool
- Keywords
- Sleep Apnea
- Medical subject headings
- Sleep Wake Disorders, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareOther
Participants will have a Positive Airway Pressure (PAP) mask chosen to wear for a period of 90 days as provided by the sites standard of care.
Mask Advice ToolOther
Participants will have a Positive Airway Pressure (PAP) mask chosen to wear for a period of 90 days as provided by the mask advice tool.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Not described Receives: Other: Standard of Care |
| Mask Advice Tool | Experimental | Not described Receives: Other: Mask Advice Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants requiring one or more mask re-fits
Proportion of participants in each arm requiring one or more mask re-fits.
Measured: 90 days
Secondary outcomes (11)
Number of masks tried during the initial fitting visit
Number of masks tried during the initial fitting visit in each arm.
Measured: 90 days
Number of masks tried after going home with the first mask
Number of masks tried after going home with the first mask in each arm.
Measured: 90 days
Amount of time to fit each mask
Amount of time to fit each mask in each arm.
Measured: 90 days
Number of sleep clinic or sleep center callbacks related to mask fitting issues
Number of sleep clinic or sleep center callbacks related to mask fitting issues in each arm.
Measured: 90 days
The amount of time spent on these calls to resolve mask issues
The amount of time spent on these calls to resolve mask issues in each arm.
Measured: 90 days
Number of unplanned visits to adjust current mask or fit with another masks
Number of unplanned visits to adjust current mask or fit with another masks in each arm.
Measured: 90 days
Duration of the unplanned visits
Duration of the unplanned visits in each arm.
Measured: 90 days
Adherence to CPAP therapy
Adherence to CPAP therapy as determined by average hours of use
Measured: 90 days
Mask leak for chosen masks
Mask leak for chosen masks in each arm.
Measured: 90 days
Subjective preference rated by patients
Patients will complete a "Post-Trial Questionnaire" to rate their post-trial experience, on a 0-10 scale. "0" meaning strongly disagree/unlikely, "10" meaning strongly agree/likely. A higher score means a better outcome.
Measured: 90 days
Subjective preference rated by clinicians
Clinicians will complete a "Post-Trial Questionnaire" to rate their post-trial experience, on a 0-10 scale. "0" meaning strongly disagree/unlikely, "10" meaning strongly agree/likely. A higher score means a better outcome.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start18 Apr 2019
- Primary completion7 Feb 2020
- Study completion7 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disorder; Breathing-RelatedStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Respironics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948152
- Sponsor's protocol ID
- SRC-SLE(PI)-CP-2018-10129
- Status last verified
- Jul 2020
- First submitted
- 8 May 2019
- Last updated
- 7 Jul 2020
- 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 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Determine Clinician and Patient Preferences Towards Interface Products Recommended by the 3D Mask Advice Tool
- ClinicalTrials.gov ID
- NCT03948152
- Acronym / sponsor ID
- SRC-SLE(PI)-CP-2018-10129
- Conditions
- Sleep Disorder; Breathing-Related
- Keywords
- Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Philips RespironicsIndustry (pharma, biotech, devices)
- Study start
- 18 Apr 2019 (actual)
- Primary completion
- 7 Feb 2020 (actual)
- Study completion
- 7 Feb 2020 (actual)
- First posted
- 13 May 2019 (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.
Enrolled Naïve participants will be randomized to one of two arms, the investigational or control arm. Once randomized the institutions will fit the participant with the procedures outlined in the protocol. Each participant will be required to trial the mask for a period of 90 days. Any Unscheduled Visits or Calls that occur during the participants 90 days documented.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Other: Standard of Care |
| Mask Advice Tool | Experimental | Other: Mask Advice Tool |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult Volunteers (ages 21-85)
- Willing and able to provide informed consent
- Able to follow instructions
- Able to read and speak in English as their primary language
- Currently diagnosed with Sleep Apnea through an in-lab sleep (polysomnography (PSG)) or home sleep testing, but has not started therapy and/or been fit with a mask.
Key exclusion criteria (17 listed)
- Pre-existing conditions such as bullous lung disease, pathologically low blood pressure, bypassed upper airway, pneumothorax, pneumocephalus, cerebral spinal fluid (CSF) leaks, cribriform plate abnormalities, and prior history of head trauma that has resulted in current cognitive dysfunction.
- Prescribed an Adaptive Servo Ventilation (ASV) device
- The presence of physical or mental limitations that would limit the ability to test the mask.
- Obstructive Sleep Apnea (OSA) diagnosis achieved through a split night sleep study
- Known allergy to silicone
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 |
|---|---|---|
| Standard of CareParticipants will have a Positive Airway Pressure (PAP) mask chosen to wear for a period of 90 days as provided by the sites standard of care. | Other | Standard of Care |
| Mask Advice ToolParticipants will have a Positive Airway Pressure (PAP) mask chosen to wear for a period of 90 days as provided by the mask advice tool. | Other | Mask Advice Tool |
Primary outcome
Proportion of participants requiring one or more mask re-fits
Time frame: 90 days
Proportion of participants in each arm requiring one or more mask re-fits.
11 secondary outcomes
Number of masks tried during the initial fitting visit
Time frame: 90 days
Number of masks tried after going home with the first mask
Time frame: 90 days
Amount of time to fit each mask
Time frame: 90 days
Number of sleep clinic or sleep center callbacks related to mask fitting issues
Time frame: 90 days
The amount of time spent on these calls to resolve mask issues
Time frame: 90 days
Number of unplanned visits to adjust current mask or fit with another masks
Time frame: 90 days
Duration of the unplanned visits
Time frame: 90 days
Adherence to CPAP therapy
Time frame: 90 days
Mask leak for chosen masks
Time frame: 90 days
Subjective preference rated by patients
Time frame: 90 days
Subjective preference rated by clinicians
Time frame: 90 days
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 7 Jul 2020.
- 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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mask Advice Tool in people with Sleep Disorder; Breathing-Related, run by Philips Respironics at 5 sites in United States.
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 5 inclusion and 17 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 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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?
Proportion of participants requiring one or more mask re-fits (time frame: 90 days). 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 7 Jul 2020.