Obstructive Sleep Apnea (OSA)NCT04559737
CPAP Population Management
A study testing Case Management in people with Obstructive Sleep Apnea (OSA), run by Kaiser Permanente at 1 site in United States.
Trial summary
The investigators propose a study to formally compare two Continuous Positive Airway Pressure (CPAP) follow-up pathways: 1) Usual care - follow-up visits reflect standard care practice and we rely on patients to reach out to us if they are struggling with therapy (there will be no active outreach); 2) Case Management… 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?
- Case Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2020to 8 Jul 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Kaiser Permanente member
- Moderate-Severe Obstructive Sleep Apnea diagnosis (AHI4%≥15 on home sleep apnea test [Nox T3 or WatchPAT] or polysomnography (in-lab study)
- PAP therapy clinically recommended and prescribed for home therapy of OSA
- Adults (age ≥ 18 years)
Who cannot join
- Chronic respiratory failure requiring bilevel PAP ventilatory support or addition of oxygen supplementation.
- Prior use of PAP prescribed for home therapy.
- Inability wirelessly connect patient's PAP device.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Sleep Center
Fontana, California, 92335
About this study
Official title: Impact of Population Management Strategies on Continuous Positive Airway Pressure Adherence
The investigators propose a study to formally compare two Continuous Positive Airway Pressure (CPAP) follow-up pathways: 1) Usual care - follow-up visits reflect standard care practice and we rely on patients to reach out to us if they are struggling with therapy (there will be no active outreach); 2) Case Management - in addition to "Usual Care" visits, patients CPAP use will be monitored and further encounters may be initiated with "struggler" CPAP users while "successful" users are passively followed.
The investigators will evaluate measures of CPAP adherence, patient engagement and cost-effectiveness for the duration of 1 year.
Our hypothesis is that "Case Management" will improve CPAP adherence and cost-effectiveness compared to "Usual Care". The investigators also hypothesize that targeting "strugglers" only in a management by exception (MBE) approach will be equally effective, but require less personnel time compared to targeting "all" patients.
Read the detailed description
Untreated obstructive sleep apnea (OSA) increases patient risks and burden on the healthcare system due to its high prevalence, impact on cardiovascular health, and daytime symptoms that cause deficits on daytime functioning. The yearly economic cost of OSA in Australia, with a population of about 25 million, is estimated to be $21 billion. Unfortunately, the effectiveness of continuous positive airway pressure (CPAP) therapy on improving patient and population outcomes is limited by suboptimal adherence with literature generally reporting adherence rates of 50-70% (defined by Medicare as ≥70% nights used ≥4 hours). The development of technology-based solutions is critical towards improving adherence, and this includes the use of remote patient monitoring, automation, and population management tools. Current CPAP devices are now wirelessly connected (eg, via cellular) which enables remote access by sleep medicine providers to access patient usage. Fox et al demonstrated the utility of remote monitoring in a randomized trial. New CPAP users that were remotely identified to have suboptimal use (and underwent a telephone encounter with a sleep medicine provider) showed significantly better 3 month CPAP use compared to the control group without monitoring (321 minutes versus 207 minutes; p<0.0001). Our center also performed a randomized trial (Tele-OSA study) in which a similar process was applied but the monitoring and patient feedback was automated. Patients with <4 hours use for 3 nights in a row were automatically sent messages (typically via SMS text) encouraging use. The investigators demonstrated the cost-effectiveness of this automated approach (Auto-Monitoring), which resulted in improved CPAP adherence without an increase in manual intervention with a provider.
Population management platforms capable of automatically risk stratifying patients (eg, automatically identifying poor users) may be another cost-effective technology-based tool by enabling a "management by exception" (MBE) follow-up process. This process concentrates provider effort on patients most at need by allowing providers to passively observe successful users and actively intervene only in CPAP strugglers. In our center, the investigators intend to implement this population management process by identifying CPAP strugglers at 1 month, 2 month, and 3 months after therapy initiation although impact on outcomes is unknown.
Time Motion Pilot
Our center proceeded with a preliminary implementation of this automated MBE process and performed a time motion study comparing time required to deliver care utilizing the population management process with automated risk stratification versus a non-automated process. The tasks performed were as follows: 1) Risk stratification (identifying patients with moderate-severe OSA), assessing CPAP Adherence (identifying those with >50% nights used at least 4 hours), telephone encounter (to troubleshoot issues with CPAP use), and documentation. The investigators demonstrated an 83% reduction in time required to follow-up a similar population of new CPAP users at any given time point (eg, 1 month, 2 months, etc.) While the results of this pilot (unpublished data) demonstrates significant improvement in care delivery efficiency, the impact on adherence remains unclear.
Population Management Study
The investigators propose a study to formally compare two CPAP follow-up pathways: 1) Usual care - a control group utilizing standard care practices with no active outreach; 2) Case Management - in addition to "Usual Care", other encounters may be initiated with CPAP strugglers while successful users are passively followed.
- Conditions
- Obstructive Sleep Apnea (OSA)
- Being tested
- Case Management
- Keywords
- Case Management (CM), Management by Exception, Continuous Positive Airway Pressure (CPAP), CPAP Adherence, Auto-monitoring, Patient Engagement, Patient Acceptance, Cost-Effective
- Medical subject headings
- Sleep Apnea, Obstructive, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case ManagementOther
Population management platforms capable of automatically risk stratifying patients (eg, automatically identifying poor users) may be another cost-effective technology-based tool by enabling a "management by exception" (MBE) follow-up intervention. This intervention concentrates provider effort on patients most at need by allowing providers to passively observe successful users and actively intervene only in CPAP strugglers. Therefore, in addition to "Usual Care" we will implement this population management process by identifying CPAP strugglers only and further follow-up encounters will be triggered for these select patients for troubleshooting. Additionally, throughout the 1-year period, Q1 window of <70% nights >4 hours will trigger a phone call and at the discretion of the sleep provider convert to video or in-person encounter for troubleshooting. CPAP Follow-Up Questionnaire will also be delivered to patient at 3 months and 1 year.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Patients will receive Auto-Monitoring text messages. The Auto-Monitoring tool that will be used is a function within Somnoware (Somnoware, Inc.) patient management platform, which is the national KP benchmarked platform for sleep management software. Fixed scheduled follow-up visits will be scheduled at 1-month (telephone encounter), 3-months (in-person or video encounter), and 1-year (in-person or video encounter). This sequence of follow-up visits reflects current real-world practice. Patients are eligible for additional visits when self-initiated. Sleep questionnaires will be delivered at 1, 3, and 6 months and at 1 year. |
| Case Management | Active comparator | Patients will undergo the same follow-up process as described in the Usual Care Pathway. A population CM dashboard (Somnoware, Inc.) will be used to automatically identify PAP strugglers (defined as <70% nights with ≥4 hours use during the preceding month) for 1 year. Video encounters will be triggered for these select patients for troubleshooting. Additionally, throughout this 1-year period, Q1 window of <70% nights >4 hours will trigger a phone call and at the discretion of the case manager convert to video or in-person encounter for troubleshooting. CPAP Follow-Up Questionnaire will also be delivered to patient at 3 months and 1 year. Receives: Other: Case Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
PAP Adherence
Evaluate the impact each arm (Usual Care \& Case Management) has on PAP adherence.
Measured: 1 year
Secondary outcomes (1)
Healthcare Provider Effort
Evaluate the cost-effectiveness of each arm by evaluating the number, estimated time and cost per encounter.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study startJul 2020 (estimated)
- Primary completion8 Jul 2020
- Study completion8 Jul 2020
Why it stopped: The study was withdrawn prior to initiation. The protocol was submitted for IRB review but was not approved, and no participants were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea (OSA)Studies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 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
- NCT04559737
- Sponsor's protocol ID
- KPSleep-005
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2020
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
The Economic Cost of Sleep Disorders in Australia. Sleep Health Foundation. Deloitte Access Economics. 2010.
Kribbs NB, Pack AI, Kline LR, Smith PL, Schwartz AR, Schubert NM, Redline S, Henry JN, Getsy JE, Dinges DF. Objective measurement of patterns of nasal CPAP use by patients with obstructive sleep apnea. Am Rev Respir Dis. 1993 Apr;147(4):887-95. doi: 10.1164/ajrccm/147.4.887.
PubMed 8466125Iftikhar IH, Valentine CW, Bittencourt LR, Cohen DL, Fedson AC, Gislason T, Penzel T, Phillips CL, Yu-sheng L, Pack AI, Magalang UJ. Effects of continuous positive airway pressure on blood pressure in patients with resistant hypertension and obstructive sleep apnea: a meta-analysis. J Hypertens. 2014 Dec;32(12):2341-50; discussion 2350. doi: 10.1097/HJH.0000000000000372.
PubMed 25243523Iftikhar IH, Hoyos CM, Phillips CL, Magalang UJ. Meta-analyses of the Association of Sleep Apnea with Insulin Resistance, and the Effects of CPAP on HOMA-IR, Adiponectin, and Visceral Adipose Fat. J Clin Sleep Med. 2015 Apr 15;11(4):475-85. doi: 10.5664/jcsm.4610.
PubMed 25700870Fox N, Hirsch-Allen AJ, Goodfellow E, Wenner J, Fleetham J, Ryan CF, Kwiatkowska M, Ayas NT. The impact of a telemedicine monitoring system on positive airway pressure adherence in patients with obstructive sleep apnea: a randomized controlled trial. Sleep. 2012 Apr 1;35(4):477-81. doi: 10.5665/sleep.1728.
PubMed 22467985
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Population Management Strategies on Continuous Positive Airway Pressure Adherence
- ClinicalTrials.gov ID
- NCT04559737
- Acronym / sponsor ID
- KPSleep-005
- Conditions
- Obstructive Sleep Apnea (OSA)
- Keywords
- Case Management (CM), Management by Exception, Continuous Positive Airway Pressure (CPAP), CPAP Adherence, Auto-monitoring, Patient Engagement, Patient Acceptance, Cost-Effective
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was withdrawn prior to initiation. The protocol was submitted for IRB review but was not approved, and no participants were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- Jul 2020 (estimated)
- Primary completion
- 8 Jul 2020 (actual)
- Study completion
- 8 Jul 2020 (actual)
- First posted
- 23 Sep 2020 (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 investigators propose a study to formally compare two Continuous Positive Airway Pressure (CPAP) follow-up pathways: 1) Usual care - follow-up visits reflect standard care practice and we rely on patients to reach out to us if they are struggling with therapy (there will be no active outreach); 2) Case Management - in addition to "Usual Care" visits, patients CPAP use will be monitored and further encounters may be initiated with "struggler" CPAP users while "successful" users are passively followed.
The investigators will evaluate measures of CPAP adherence, patient engagement and cost-effectiveness for the duration of 1 year.
Our hypothesis is that "Case Management" will improve CPAP adherence and cost-effectiveness compared to "Usual Care". The investigators also hypothesize that targeting "strugglers" only in a management by exception (MBE) approach will be equally effective, but require less personnel time compared to targeting "all" patients.
Detailed description
Untreated obstructive sleep apnea (OSA) increases patient risks and burden on the healthcare system due to its high prevalence, impact on cardiovascular health, and daytime symptoms that cause deficits on daytime functioning. The yearly economic cost of OSA in Australia, with a population of about 25 million, is estimated to be $21 billion. Unfortunately, the effectiveness of continuous positive airway pressure (CPAP) therapy on improving patient and population outcomes is limited by suboptimal adherence with literature generally reporting adherence rates of 50-70% (defined by Medicare as ≥70% nights used ≥4 hours). The development of technology-based solutions is critical towards improving adherence, and this includes the use of remote patient monitoring, automation, and population management tools. Current CPAP devices are now wirelessly connected (eg, via cellular) which enables remote access by sleep medicine providers to access patient usage. Fox et al demonstrated the utility of remote monitoring in a randomized trial. New CPAP users that were remotely identified to have suboptimal use (and underwent a telephone encounter with a sleep medicine provider) showed significantly better 3 month CPAP use compared to the control group without monitoring (321 minutes versus 207 minutes; p<0.0001). Our center also performed a randomized trial (Tele-OSA study) in which a similar process was applied but the monitoring and patient feedback was automated. Patients with <4 hours use for 3 nights in a row were automatically sent messages (typically via SMS text) encouraging use. The investigators demonstrated the cost-effectiveness of this automated approach (Auto-Monitoring), which resulted in improved CPAP adherence without an increase in manual intervention with a provider.
Population management platforms capable of automatically risk stratifying patients (eg, automatically identifying poor users) may be another cost-effective technology-based tool by enabling a "management by exception" (MBE) follow-up process. This process concentrates provider effort on patients most at need by allowing providers to passively observe successful users and actively intervene only in CPAP strugglers. In our center, the investigators intend to implement this population management process by identifying CPAP strugglers at 1 month, 2 month, and 3 months after therapy initiation although impact on outcomes is unknown.
Time Motion Pilot
Our center proceeded with a preliminary implementation of this automated MBE process and performed a time motion study comparing time required to deliver care utilizing the population management process with automated risk stratification versus a non-automated process. The tasks performed were as follows: 1) Risk stratification (identifying patients with moderate-severe OSA), assessing CPAP Adherence (identifying those with >50% nights used at least 4 hours), telephone encounter (to troubleshoot issues with CPAP use), and documentation. The investigators demonstrated an 83% reduction in time required to follow-up a similar population of new CPAP users at any given time point (eg, 1 month, 2 months, etc.) While the results of this pilot (unpublished data) demonstrates significant improvement in care delivery efficiency, the impact on adherence remains unclear.
Population Management Study
The investigators propose a study to formally compare two CPAP follow-up pathways: 1) Usual care - a control group utilizing standard care practices with no active outreach; 2) Case Management - in addition to "Usual Care", other encounters may be initiated with CPAP strugglers while successful users are passively followed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Patients will receive Auto-Monitoring text messages. The Auto-Monitoring tool that will be used is a function within Somnoware (Somnoware, Inc.) patient management platform, which is the national KP benchmarked platform for sleep management software. Fixed scheduled follow-up visits will be scheduled at 1-month (telephone encounter), 3-months (in-person or video encounter), and 1-year (in-person or video encounter). This sequence of follow-up visits reflects current real-world practice. Patients are eligible for additional visits when self-initiated. Sleep questionnaires will be delivered at 1, 3, and 6 months and at 1 year. |
| Case Management | Active comparator | Other: Case ManagementPatients will undergo the same follow-up process as described in the Usual Care Pathway. A population CM dashboard (Somnoware, Inc.) will be used to automatically identify PAP strugglers (defined as <70% nights with ≥4 hours use during the preceding month) for 1 year. Video encounters will be triggered for these select patients for troubleshooting. Additionally, throughout this 1-year period, Q1 window of <70% nights >4 hours will trigger a phone call and at the discretion of the case manager convert to video or in-person encounter for troubleshooting. CPAP Follow-Up Questionnaire will also be delivered to patient at 3 months and 1 year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Kaiser Permanente member
- Moderate-Severe Obstructive Sleep Apnea diagnosis (AHI4%≥15 on home sleep apnea test [Nox T3 or WatchPAT] or polysomnography (in-lab study)
- PAP therapy clinically recommended and prescribed for home therapy of OSA
- Adults (age ≥ 18 years)
Key exclusion criteria (3 listed)
- Chronic respiratory failure requiring bilevel PAP ventilatory support or addition of oxygen supplementation.
- Prior use of PAP prescribed for home therapy.
- Inability wirelessly connect patient's PAP device.
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 |
|---|---|---|
| Case ManagementPopulation management platforms capable of automatically risk stratifying patients (eg, automatically identifying poor users) may be another cost-effective technology-based tool by enabling a "management by exception" (MBE) follow-up intervention. This intervention concentrates provider effort on patients most at need by allowing providers to passively observe successful users and actively intervene only in CPAP strugglers. Therefore, in addition to "Usual Care" we will implement this population management process by identifying CPAP strugglers only and further follow-up encounters will be triggered for these select patients for troubleshooting. Additionally, throughout the 1-year period, Q1 window of <70% nights >4 hours will trigger a phone call and at the discretion of the sleep provider convert to video or in-person encounter for troubleshooting. CPAP Follow-Up Questionnaire will also be delivered to patient at 3 months and 1 year. | Other | Case Management |
Primary outcome
PAP Adherence
Time frame: 1 year
Evaluate the impact each arm (Usual Care \& Case Management) has on PAP adherence.
1 secondary outcome
Healthcare Provider Effort
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- BackgroundThe Economic Cost of Sleep Disorders in Australia. Sleep Health Foundation. Deloitte Access Economics. 2010.
- Background: PubMed 8466125Kribbs NB, Pack AI, Kline LR, Smith PL, Schwartz AR, Schubert NM, Redline S, Henry JN, Getsy JE, Dinges DF. Objective measurement of patterns of nasal CPAP use by patients with obstructive sleep apnea. Am Rev Respir Dis. 1993 Apr;147(4):887-95. doi: 10.1164/ajrccm/147.4.887.
- Background: PubMed 25243523Iftikhar IH, Valentine CW, Bittencourt LR, Cohen DL, Fedson AC, Gislason T, Penzel T, Phillips CL, Yu-sheng L, Pack AI, Magalang UJ. Effects of continuous positive airway pressure on blood pressure in patients with resistant hypertension and obstructive sleep apnea: a meta-analysis. J Hypertens. 2014 Dec;32(12):2341-50; discussion 2350. doi: 10.1097/HJH.0000000000000372.
- Background: PubMed 25700870Iftikhar IH, Hoyos CM, Phillips CL, Magalang UJ. Meta-analyses of the Association of Sleep Apnea with Insulin Resistance, and the Effects of CPAP on HOMA-IR, Adiponectin, and Visceral Adipose Fat. J Clin Sleep Med. 2015 Apr 15;11(4):475-85. doi: 10.5664/jcsm.4610.
- Background: PubMed 22467985Fox N, Hirsch-Allen AJ, Goodfellow E, Wenner J, Fleetham J, Ryan CF, Kwiatkowska M, Ayas NT. The impact of a telemedicine monitoring system on positive airway pressure adherence in patients with obstructive sleep apnea: a randomized controlled trial. Sleep. 2012 Apr 1;35(4):477-81. doi: 10.5665/sleep.1728.
Related trials for Obstructive Sleep Apnea (OSA)
Not yet recruitingObservational study
EEG Markers From Polysomnography and Cognitive Performance in Obstructive Sleep Apnea
Obstructive Sleep Apnea, Cognitive Impairment
Not yet recruiting
Testing Settings of NovaResp's cMAP® Software During Home PAP Therapy
Obstructive Sleep Apnea
Recruiting
A Study of the Sleepnet Elara APAP Device
Sleep Apnea - Obstructive
Recruiting
Physical Activity, Sleep Quality, and Respiratory Function in Obstructive Sleep Apnea
Obstructive Sleep Apnea, Sleep Quality
Active, not recruiting
The Impact of Technology in Obstructive Sleep Apnea Myofunctional Therapy
Obstructive Sleep Apnea (OSA), Snoring
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 Case Management 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 4 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: withdrawn, as of the sponsor's last update on 20 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
PAP Adherence (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04559737, which also lists 5 linked publications.
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 20 Jul 2026.