SAM Clinic Intervention for Sleep Apnea

Overseen By Kylie Phillips, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Central sleep apnea, Cheyne-Stokes, pregnant, others

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

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a special sleep apnea management group (SAM Clinic Intervention) can improve the use of Positive Airway Pressure (PAP) machines. The goal is to determine if attending this group enhances PAP usage, quality of life, and reduces daytime sleepiness and depression compared to standard care from a regular doctor. The trial seeks participants with moderate-to-severe obstructive sleep apnea who have recently started using a PAP machine and are struggling with regular use. As an unphased trial, it offers a unique opportunity to explore innovative methods to enhance treatment experiences and improve quality of life.

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 sleep apnea management and PAP machine usage.

What prior data suggests that the SAM Clinic Intervention is safe for improving PAP adherence?

Research has shown that the SAM Clinic Intervention for sleep apnea helps people use their Positive Airway Pressure (PAP) machines more effectively. This treatment employs group support to increase the frequency and quality of PAP machine use, improving breathing during sleep.

No reports of serious side effects have emerged from the SAM Clinic Intervention. The treatment is generally well-tolerated, as it emphasizes group support and education rather than medication or physical procedures. While studies suggest improved outcomes, further research is needed to confirm these results. Overall, the SAM Clinic Intervention is not expected to pose significant safety risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The SAM Clinic Intervention for sleep apnea is unique because it focuses on improving adherence to positive airway pressure (PAP) therapy through a group-based management approach. Unlike traditional treatments that often involve individual follow-ups with non-sleep specialists, this intervention provides a supportive group setting, which can enhance motivation and compliance. Researchers are excited about this because better adherence to PAP therapy can lead to more effective management of sleep apnea symptoms, ultimately improving patients' quality of life.

What evidence suggests that the SAM Clinic Intervention is effective for improving PAP adherence in sleep apnea patients?

Research has shown that the SAM Clinic Intervention, which participants in this trial may receive, might help people with sleep apnea use their PAP machines more regularly. One study found that after attending the SAM clinic, patients used their machines more often and for longer periods. Another study observed trends towards better PAP usage and improved quality of life, although the changes were not very large. Overall, the SAM approach seems promising for helping people adhere to their PAP therapy, which is important for effectively treating sleep apnea. ^{1 2 4 5 6}

Who Is on the Research Team?

Catherine Heinzinger, DO

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

Adults over 18 with moderate-to-severe obstructive sleep apnea who are new to using a PAP machine and aren't using it enough (<70% usage, <4 hours daily). They must be under the care of non-sleep specialists and able to attend the SAM clinic. Pregnant women, those on oxygen therapy, or unable to consent are excluded.

Inclusion Criteria

You have had a new PAP test within the past month.

You don't use your PAP machine enough, less than 70% of the time and less than 4 hours a night on average.

I have moderate to severe sleep apnea.

Exclusion Criteria

Pregnant women

I have central sleep apnea or Cheyne-Stokes breathing.

I cannot go to the SAM clinic.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline questionnaires and are randomized to either the SAM Clinic or usual care group

1 day

1 visit (in-person)

Treatment

Participants receive interventions based on their group assignment: SAM Clinic intervention or usual care

12 weeks

3 visits (in-person) at baseline, 4 weeks, and 12 weeks

Follow-up

Participants are monitored for changes in PAP adherence, depressive symptoms, global health, sleep impairment, fatigue, and daytime sleepiness

3 months

2 visits (in-person) at 1 month and 3 months

What Are the Treatments Tested in This Trial?

Interventions

• SAM Clinic Intervention

Trial Overview

The trial is testing a group intervention called SAM Clinic Intervention for people with sleep apnea who struggle with their PAP machine use. It aims to see if this support improves how often they use their machines and enhances quality of life, alertness during the day, and mood compared to usual care.

How Is the Trial Designed?

Group I: SAM Clinic Intervention Experimental Treatment 1 Intervention

Participants will attend a sleep apnea management group based intervention to improve PAP adherence.

Group II: Usual care with non-sleep provider Active Control 1 Intervention

Participant will continue the follow up for sleep apnea with the non-sleep provider

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

ResMed

Industry Sponsor

Trials

138

Recruited

47,600+

Mick Farrell

ResMed

Chief Executive Officer since 2013

Bachelor of Engineering from the University of New South Wales, Master of Science in Chemical Engineering from MIT, MBA from MIT Sloan School of Management

Dr. Carlos Nunez

ResMed

Chief Medical Officer since 2017

MD

Published Research Related to This Trial

In a study analyzing 65 safety events during polysomnography from January 2016 to January 2020, the rate of adverse events was found to be 1 in 147 studies, indicating a higher incidence than previously thought, especially in patients with multiple medical comorbidities.

The implementation of a formalized response protocol for sleep technicians significantly reduced the median response time to safety incidents to 3 minutes, highlighting the importance of training and preparedness in managing potential medical emergencies during sleep studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A protocol for mitigating safety events in a sleep laboratory. Blattner, M., Dunham, K., Thomas, R., et al.[2022]

In a study involving 104 participants with mild to moderate obstructive sleep apnea, the use of sham-CPAP showed statistically significant but small changes in sleep quality, indicating it can serve as an effective placebo in clinical trials.

The differences observed in sleep metrics, such as decreased sleep efficiency and increased arousal, suggest that while sham-CPAP impacts sleep, these effects are minimal and clinically insignificant, supporting its use in evaluating true CPAP treatment effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of sham-CPAP as a placebo in CPAP intervention studies. Rodway, GW., Weaver, TE., Mancini, C., et al.[2022]

In a randomized trial involving 48 patients with moderate to severe sleep apnea, those treated with optimal CPAP showed significantly greater improvements in sleepiness and other SAHS-related symptoms compared to those receiving sham CPAP, confirming the efficacy of CPAP treatment.

The study demonstrated that even patients who initially received sham CPAP experienced significant improvements in symptoms when switched to optimal CPAP, highlighting the treatment's effectiveness in enhancing overall health and productivity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of CPAP treatment in daytime function in sleep apnea syndrome: a randomized controlled study with an optimized placebo. Montserrat, JM., Ferrer, M., Hernandez, L., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11971166/

Impact of a multidisciplinary sleep apnea management group ...

The SAM clinic demonstrated trends toward improved PAP adherence and PROs compared to usual care, though differences were not statistically significant.

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40184007

Impact of a multidisciplinary sleep apnea management group ...

The SAM clinic demonstrated trends toward improved PAP adherence and PROs compared to usual care, though differences were not statistically ...

3.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/02/NCT03835702/Prot_SAP_000.pdf

Impact of a Novel Sleep Apnea Management Group ...

Hypothesis 1: We hypothesize that the SAM clinic intervention will result in improved PAP adherence versus usual care. ... effectiveness of SAM ...

4.

withpower.com

withpower.com/trial/phase-sleep-apnea-syndromes-3-2019-ffb28

SAM Clinic Intervention for Sleep Apnea · Info for Participants

In a study involving 104 participants with mild to moderate obstructive sleep apnea, the use of sham-CPAP showed statistically significant but small changes in ...

5.

link.springer.com

link.springer.com/article/10.1007/s11325-021-02352-w

Impact of the sleep apnea management group clinic on ...

In this study, after the SAM clinic, all PAP adherence parameters improved significantly. This observational study serves as a proof of concept study for ...

6.

academic.oup.com

academic.oup.com/sleep/article/47/Supplement_1/A243/7654551

0570 Impact of a Sleep Apnea Management Group Clinic on ...

SAM clinic may improve PAP adherence and some PROs better than usual care; however future studies are needed to confirm findings.