Obstructive Sleep Apnea (OSA)TriagingToolNCT05530967
Assessing the Validity of the PAP Problems Triage Tool in Patients With PAP Treatment for Obstructive Sleep Apnea
A study testing TT and VE in people with Obstructive Sleep Apnea (OSA), run by Kaiser Permanente at 1 site in United States.
Trial summary
The intended use of the Positive Airway Pressure (PAP) Problems Triaging Tool (TT) is to appropriately triage patients with a PAP-associated problem(s) to a specific intervention(s) based on patient responses. 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?
- TT and VE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 355 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Kaiser Permanente Member (KP insured)
- OSA diagnosis by polysomnogram or Home Sleep Apnea Test with Apnea Hypopnea Index ≥ 15 events/hour
- PAP naïve
- Able to consent to participate
- Fluent or proficient with English
- Accepts PAP for home treatment
Who cannot join
- Chronic respiratory failure requiring Oxygen supplementation
- PAP device other than a PAP or AutoPAP (i.e., bilevel PAP)
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Fontana Sleep Clinic
Fontana, California, 92335
About this study
Official title: Assessing the Structure and Validity of the PAP Problems Triage Tool in Patients With Newly-Initiated PAP Treatment for Obstructive Sleep Apnea
The intended use of the Positive Airway Pressure (PAP) Problems Triaging Tool (TT) is to appropriately triage patients with a PAP-associated problem(s) to a specific intervention(s) based on patient responses. Thus, the proposed research will validate the tool, determine optimal scoring thresholds, and explore the utility of the tool as an indicator for intervention. Our central hypothesis is that the PAP Problems TT will identify treatment barriers that if unaddressed, are predictive of treatment non-adherence.
Read the detailed description
This study is a one-group observational design that uses a TT questionnaire and abstraction of PAP use data from a clinically available interface (Somnoware™). Consecutive adults with OSA and recommended to PAP treatment at the Fontana Medical Sleep Center will be invited to the study. Once the patient has been prescribed PAP therapy and has indicated their willingness to participate the TT will be sent digitally from Somnoware™. Participants will receive the TT in accordance to the next time interval defined by the study protocol. A randomly selected sub-group of participants will automatically receive an animated education video delivered digitally from Somnoware™. These videos will provide targeted information for self-managing the endorsed PAP problem.
Diagnostic polysomnogram (PSG) or home sleep apnea test (HSAT) data will be abstracted from Somnoware™. Daily PAP data will be abstracted from Somnoware™ for the first 35-days of PAP use. Demographic data will also be abstracted at day 35 (from the patient's clinical intake questionnaire and electronic health record).
- Conditions
- Obstructive Sleep Apnea (OSA)
- Being tested
- TT, VE
- Keywords
- Positive Airway Pressure (PAP) Therapy, Triaging Tool, PAP Problems, PAP Adherence
- 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.
TTOther
This intervention uses questionnaire at three-time intervals (i.e., days 5, 10, and 30) and abstraction of PAP use data (days 1 - 35). Consecutive adults with moderate-severe OSA and recommended to PAP treatment will be invited to the study. Once the patient has been prescribed PAP therapy a research associate will call the patient before receiving their new PAP device. The research associate will utilize an IRB approved telephone script to discuss study details, conduct eligibility screening (inclusion/exclusion criteria), and to ask whether the patient is interested in participating.
The research associate will then send the patient an IRB approved digital information sheet. The information sheet will provide the patient an option to mark "Yes" if they are willing to participate in the study or "No" if they are not willing. Patients who indicate their willingness to participate will receive the Triage Tool in accordance with the study protocol.
VEOther
A randomly selected sub-group of participants (n=30) will also receive an animated education video that provides targeted information and encouragement for self-managing your PAP problem(s). Patients in this sub-group will be asked to view a maximum of 2 different videos that are less than 2 minutes in duration. These videos are aligned with practice guideline recommendations for addressing PAP problems early in treatment. The videos will be sent digitally from Somnoware™.
| Study group | Role | What they receive |
|---|---|---|
| Triaging Tool | Experimental | Not described Receives: Other: TT |
| Video Education | Experimental | Not described Receives: Other: TT; Other: VE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Factor Analysis
Investigate the factor structure of the TT, an exploratory factor analysis (EFA) will be conducted. A forced six-factor EFA using a varimax rotation will be conducted to determine the factor loadings on six sub-scales and to determine whether the EFA factors are similar to the theoretically derived categories from the original TT instrument. Data from the TT collected at day 5 will be used for the factor analysis as we expect higher response rate at this first data collection endpo
Measured: 30 days
Triaging Tool Validity
Concurrent validity will assess the extent to which TT scores are related to concurrent PAP use. This will be established based on Pearson product moment correlation coefficients (for continuous PAP use [hours/night]) and Point Biserial correlations (for PAP non-adherence, defined as <4 hours/night of use, on average) at three intervals: day 5 (PAP use on days 1-5), day 10 (PAP use on days 6-10), and day 30 (PAP use on days 11-30).
Measured: 30 days
Triaging Tool Predictive Validity
To determine the TT accuracy for predicting PAP non-adherence (defined as <4 hours/night of use, on average) receiver operating characteristic (ROC) curves and respective area under the curve (AUC) with 95% confidence interval (CI) will be estimated using PAP TT subdomain scores as predictors for PAP non-adherence within 5 days post-TT score data collection. As TT data will be collected at 3 intervals (i.e., days 5, 10, and 30) and considering the 6 subdomains from the TT scale, a total of 18 ROCs/AUCs will be estimated.
Measured: 30 days
Secondary outcomes (1)
Changes in PAP Use Utilizing Video Education
Unadjusted, descriptive analysis will be conducted to explore acute changes in PAP use immediately after intervention delivery. Change in PAP use will be assessed by computing the difference (delta) in PAP use (mean, hours/night) for the 5 consecutive days pre- and post-VE. Positive delta values will indicate greater PAP use post-intervention delivery.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start8 Feb 2023
- Primary completion6 Nov 2024
- Study completionDec 2026 (estimated)
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 Kaiser PermanenteThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dennis Hwang, MD, Kaiser Permanente
- Investigators
- Dennis Hwang, MD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530967
- Sponsor's protocol ID
- KPSleep-006
- Acronym
- TriagingTool
- Status last verified
- Jul 2026
- First submitted
- 5 Jul 2022
- Last updated
- 21 Jul 2026
- 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 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Structure and Validity of the PAP Problems Triage Tool in Patients With Newly-Initiated PAP Treatment for Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT05530967
- Acronym / sponsor ID
- TriagingTool / KPSleep-006
- Conditions
- Obstructive Sleep Apnea (OSA)
- Keywords
- Positive Airway Pressure (PAP) Therapy, Triaging Tool, PAP Problems, PAP Adherence
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 355 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- 8 Feb 2023 (actual)
- Primary completion
- 6 Nov 2024 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Sep 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.
The intended use of the Positive Airway Pressure (PAP) Problems Triaging Tool (TT) is to appropriately triage patients with a PAP-associated problem(s) to a specific intervention(s) based on patient responses. Thus, the proposed research will validate the tool, determine optimal scoring thresholds, and explore the utility of the tool as an indicator for intervention. Our central hypothesis is that the PAP Problems TT will identify treatment barriers that if unaddressed, are predictive of treatment non-adherence.
Detailed description
This study is a one-group observational design that uses a TT questionnaire and abstraction of PAP use data from a clinically available interface (Somnoware™). Consecutive adults with OSA and recommended to PAP treatment at the Fontana Medical Sleep Center will be invited to the study. Once the patient has been prescribed PAP therapy and has indicated their willingness to participate the TT will be sent digitally from Somnoware™. Participants will receive the TT in accordance to the next time interval defined by the study protocol. A randomly selected sub-group of participants will automatically receive an animated education video delivered digitally from Somnoware™. These videos will provide targeted information for self-managing the endorsed PAP problem.
Diagnostic polysomnogram (PSG) or home sleep apnea test (HSAT) data will be abstracted from Somnoware™. Daily PAP data will be abstracted from Somnoware™ for the first 35-days of PAP use. Demographic data will also be abstracted at day 35 (from the patient's clinical intake questionnaire and electronic health record).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triaging Tool | Experimental | Other: TT |
| Video Education | Experimental | Other: TT, Other: VE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Kaiser Permanente Member (KP insured)
- OSA diagnosis by polysomnogram or Home Sleep Apnea Test with Apnea Hypopnea Index ≥ 15 events/hour
- PAP naïve
- Able to consent to participate
- Fluent or proficient with English
Key exclusion criteria (3 listed)
- Chronic respiratory failure requiring Oxygen supplementation
- PAP device other than a PAP or AutoPAP (i.e., bilevel PAP)
- Pregnant
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 |
|---|---|---|
| TTThis intervention uses questionnaire at three-time intervals (i.e., days 5, 10, and 30) and abstraction of PAP use data (days 1 - 35). Consecutive adults with moderate-severe OSA and recommended to PAP treatment will be invited to the study. Once the patient has been prescribed PAP therapy a research associate will call the patient before receiving their new PAP device. The research associate will utilize an IRB approved telephone script to discuss study details, conduct eligibility screening (inclusion/exclusion criteria), and to ask whether the patient is interested in participating. The research associate will then send the patient an IRB approved digital information sheet. The information sheet will provide the patient an option to mark "Yes" if they are willing to participate in the study or "No" if they are not willing. Patients who indicate their willingness to participate will receive the Triage Tool in accordance with the study protocol. | Other | Triaging Tool, Video Education |
| VEA randomly selected sub-group of participants (n=30) will also receive an animated education video that provides targeted information and encouragement for self-managing your PAP problem(s). Patients in this sub-group will be asked to view a maximum of 2 different videos that are less than 2 minutes in duration. These videos are aligned with practice guideline recommendations for addressing PAP problems early in treatment. The videos will be sent digitally from Somnoware™. | Other | Video Education |
Primary outcome
Factor Analysis
Time frame: 30 days
Investigate the factor structure of the TT, an exploratory factor analysis (EFA) will be conducted. A forced six-factor EFA using a varimax rotation will be conducted to determine the factor loadings on six sub-scales and to determine whether the EFA factors are similar to the theoretically derived categories from the original TT instrument. Data from the TT collected at day 5 will be used for the factor analysis as we expect higher response rate at this first data collection endpo
Triaging Tool Validity
Time frame: 30 days
Concurrent validity will assess the extent to which TT scores are related to concurrent PAP use. This will be established based on Pearson product moment correlation coefficients (for continuous PAP use [hours/night]) and Point Biserial correlations (for PAP non-adherence, defined as <4 hours/night of use, on average) at three intervals: day 5 (PAP use on days 1-5), day 10 (PAP use on days 6-10), and day 30 (PAP use on days 11-30).
Triaging Tool Predictive Validity
Time frame: 30 days
To determine the TT accuracy for predicting PAP non-adherence (defined as <4 hours/night of use, on average) receiver operating characteristic (ROC) curves and respective area under the curve (AUC) with 95% confidence interval (CI) will be estimated using PAP TT subdomain scores as predictors for PAP non-adherence within 5 days post-TT score data collection. As TT data will be collected at 3 intervals (i.e., days 5, 10, and 30) and considering the 6 subdomains from the TT scale, a total of 18 ROCs/AUCs will be estimated.
1 secondary outcome
Changes in PAP Use Utilizing Video Education
Time frame: 5 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- 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.
Dennis Hwang, MD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TT and VE in people with Obstructive Sleep Apnea (OSA), run by Kaiser Permanente at 1 site 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 6 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 21 Jul 2026. 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Factor Analysis (time frame: 30 days). The study lists 3 primary outcomes in all. 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 21 Jul 2026.