Case Management for Sleep Apnea

Overseen By Dennis Hwang, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

Disqualifiers: Chronic respiratory failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 year

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two methods of supporting individuals who use CPAP machines for sleep apnea: the usual care approach and a case management approach. Usual care involves standard follow-ups and relies on patients to report any issues. Case management, a structured support program, provides additional monitoring and support for those struggling with CPAP use. The trial will assess adherence to CPAP therapy and the cost-effectiveness of each approach over a year. It is suitable for Kaiser Permanente members diagnosed with moderate to severe sleep apnea who have been recommended and prescribed CPAP therapy for home use. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance CPAP support strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on managing sleep apnea with CPAP therapy.

What prior data suggests that these CPAP follow-up pathways are safe?

Research has shown that Continuous Positive Airway Pressure (CPAP) is generally safe for treating sleep apnea. CPAP, a machine that aids breathing during sleep, has been linked to fewer heart problems and a lower risk of death in older adults with sleep apnea. Evidence also indicates that CPAP can reduce the risk of car accidents by improving sleep quality and daytime alertness. Overall, CPAP is well-tolerated and has been used by many people over time without major issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach to managing sleep apnea through case management. Unlike traditional treatments that focus on using CPAP machines with little ongoing support, this method uses a case management dashboard to identify and assist patients who struggle with consistent CPAP use. This proactive strategy includes video and phone calls for troubleshooting, aiming to improve adherence and effectiveness. By personalizing support, researchers hope to enhance patient outcomes and provide insights into better long-term management of sleep apnea.

What evidence suggests that this case management approach is effective for sleep apnea?

This trial will compare usual care with a case management approach for patients with obstructive sleep apnea (OSA). Research has shown that managing patient care can enhance adherence to CPAP therapy for OSA. A more organized care plan often leads to better treatment outcomes and more frequent use of CPAP machines. In this trial, the case management arm will target patients who struggle with CPAP use, specifically identifying those who use the device less than 70% of the time, to provide additional support. CPAP is the primary treatment for OSA, and improving its use can have a significant impact. ^{5 6 7 8 9}

Who Is on the Research Team?

Dennis Hwang, MD

Principal Investigator

Kaiser Permanente

Are You a Good Fit for This Trial?

This trial is for adults over 18 with moderate to severe Obstructive Sleep Apnea who are recommended CPAP therapy and haven't used it at home before. Participants must be Kaiser Permanente members and able to wirelessly connect their CPAP device.

Inclusion Criteria

I have been diagnosed with moderate to severe sleep apnea.

I am prescribed PAP therapy for sleep apnea to use at home.

You are a member of Kaiser Permanente.

Exclusion Criteria

You can't connect your breathing device wirelessly.

I have used a PAP machine at home as prescribed.

I need a machine to help me breathe or extra oxygen.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CPAP therapy with follow-up pathways including Usual Care and Case Management

1 year

Scheduled follow-up visits at 1 month (telephone), 3 months (in-person or video), and 1 year (in-person or video)

Follow-up

Participants are monitored for CPAP adherence, patient engagement, and cost-effectiveness

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Case Management

Trial Overview The study compares two follow-up methods for CPAP users: 'Usual Care' where patients self-report issues, versus 'Case Management' where usage is monitored and additional support is given based on need. The goal is to see which method leads to better adherence and cost-effectiveness over a year.

How Is the Trial Designed?

Group I: Usual Care Active Control 1 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.

Group II: Case Management Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8942873/

SLEEP APNOEA IN THE ELDERLY: A GREAT CHALLENGE ... OSA is associated with pathological processes that may accelerate aging and aging related processes; aging may cause physical and neurological changes.

2. jcsm.aasm.org jcsm.aasm.org/doi/abs/10.5664/jcsm.6936

Patient-Reported Outcomes in Older Adults With Obstructive ... This study adds to the limited data on treatment outcomes with CPAP therapy in older adults with OSA. Patients older than 60 years achieve improvement in ...

3. frontiersin.org frontiersin.org/journals/sleep/articles/10.3389/frsle.2025.1593874/full

Managing sleep apnea: long-term outcomes from a ... The purpose of this study was to determine the impact of a streamlined OSA care pathway on quality of care and PAP adoption/adherence.

4. mdpi.com mdpi.com/2077-0383/13/24/7718

Challenges in Obstructive Sleep Apnea Management ... However, even among older acceptors, 37% of patients stop treatment within the first year, much more often than in younger patients [41]. Regarding compliance, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9373878/

The Management of Obstructive Sleep Apnea in Primary Care Sleep specialists may be consulted for the evaluation and treatment of OSA. Continuous positive airway pressure (CPAP) is the mainstay of OSA treatment.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9788062/

Sleep and Safety among Healthcare Workers: The Effect of ... This article reviews hypersomnolence and sleep disorder as key clinical features of OSA and their effect on HCW safety.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11676951/

Challenges in Obstructive Sleep Apnea Management in ... A recent Swiss epidemiologic study reported that 60% of men and 35% of women older than 60 years of age exhibit at least moderate OSA on sleep ...

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2823539

Positive Airway Pressure, Mortality, and CV Risk in Older ... In this cohort study of Medicare beneficiaries with OSA, PAP utilization was associated with lower all-cause mortality and MACE incidence.

9. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.10832

Long-term health outcomes for patients with obstructive sleep ... These authors reported a risk ratio of 0.43 (95% confidence interval: 0.30–0.63) for MVCs following CPAP therapy, similar to the overall point estimate. These ...