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

56 Participants Needed

Trial Summary

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 data supports the effectiveness of the SAM Clinic Intervention treatment for sleep apnea?

The research suggests that continuous positive airway pressure (CPAP) treatment, which is a common therapy for sleep apnea, significantly improves symptoms like daytime sleepiness. This indicates that similar interventions, like the SAM Clinic Intervention, could also be effective in managing sleep apnea symptoms. ^{1 2 3 4 5}

Is the SAM Clinic Intervention for Sleep Apnea safe for humans?

The safety of sleep apnea treatments, like those used in sleep laboratories, is generally considered good, with low rates of adverse events. However, patients with more complex medical conditions may face higher risks, highlighting the importance of proper protocols and trained staff to handle any safety issues. ^{6 7 8 9 10}

What is the purpose of this trial?

This randomized controlled trial will evaluate people who have moderate-to-severe obstructive sleep apnea (OSA), and have been newly prescribed a Positive Airway Pressure (PAP) machine. Patients with suboptimal adherence, defined by the Center of Medicare and Medicaid criteria (\<70 % usage and \<4 hours of average daily PAP usage) will be identified. The purpose of this research is to examine the impact of the sleep apnea management (SAM) grouped based-intervention on positive airway pressure adherence and patient report outcomes questionnaires (quality of life, daytime sleepiness and depressive symptoms) and PAP barrier questionnaire compared to a patient group managed by regular non-sleep prescribing provider.

Research Team

Catherine Heinzinger, DO

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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 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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Simple interventions improve re-attendance when treating the sleep apnoea syndrome. [2006]

2. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of CPAP treatment in daytime function in sleep apnea syndrome: a randomized controlled study with an optimized placebo. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluation of sham-CPAP as a placebo in CPAP intervention studies. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

A national survey of the effect of sleep medicine specialists and American Academy of Sleep Medicine Accreditation on management of obstructive sleep apnea. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Evaluation of treatment efficacy in sleep apnea hypopnea syndrome. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

A protocol for mitigating safety events in a sleep laboratory. [2022]

7. Australia pubmed.ncbi.nlm.nih.gov

Clinical side effects of continuous positive airway pressure in patients with obstructive sleep apnoea. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

A Scoping Review of Sleep Apnea: Where Do We Stand? [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Can intensive support improve continuous positive airway pressure use in patients with the sleep apnea/hypopnea syndrome? [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

[Sleep-related respiratory disorders: early detection and follow-up by close patient contact]. [2013]