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SAM Clinic Intervention for Sleep Apnea

N/A
Waitlist Available
Led By Catherine Heinzinger, DO
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥18 years old
Moderate to severe OSA (apnea hypopnea index (AHI)≥15 events/hr) on polysomnogram (PSG)
Must not have
Central sleep apnea (>50% apneas are central) and/or presence of Cheyne-Stokes breathing
Patients not able to attend SAM clinic
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 3 month follow up
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare the effects of two different types of care for people with sleep apnea. The first group will get the usual care from their non-sleep prescribing provider. The second group will get care from a sleep apnea management group, which may result in better adherence to positive airway pressure and better patient outcomes.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this study focuses on behavioral intervention rather than medication, there may not be direct side effects like drugs have. However, participants might experience discomfort or inconvenience due to increased clinic visits or changes in routine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have moderate to severe sleep apnea.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have central sleep apnea or Cheyne-Stokes breathing.
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I cannot go to the SAM clinic.
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I use supplemental oxygen.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 3 month follow up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 3 month follow up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hours of PAP usage (>4 hours) in last 4 weeks and at 12 weeks.
Percent days of PAP use in last 4 weeks and at 12 weeks.
Secondary study objectives
Daytime Somnolence
Depressive Symptoms
Fatigue
+2 more
Other study objectives
Masks

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SAM Clinic InterventionExperimental Treatment1 Intervention
Participants will attend a sleep apnea management group based intervention to improve PAP adherence.
Group II: Usual care with non-sleep providerActive Control1 Intervention
Participant will continue the follow up for sleep apnea with the non-sleep provider

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,056 Previous Clinical Trials
1,371,561 Total Patients Enrolled
3 Trials studying Sleep Apnea
676 Patients Enrolled for Sleep Apnea
ResMedIndustry Sponsor
136 Previous Clinical Trials
47,491 Total Patients Enrolled
7 Trials studying Sleep Apnea
3,953 Patients Enrolled for Sleep Apnea
Catherine Heinzinger, DOPrincipal InvestigatorThe Cleveland Clinic
Reena Mehra, MD4.52 ReviewsPrincipal Investigator - The Cleveland Clinic
The Cleveland Clinic
4 Previous Clinical Trials
326 Total Patients Enrolled
2 Trials studying Sleep Apnea
326 Patients Enrolled for Sleep Apnea
5Patient Review
It was a great experience.

Media Library

SAM Clinic Intervention Clinical Trial Eligibility Overview. Trial Name: NCT03835702 — N/A
Sleep Apnea Research Study Groups: SAM Clinic Intervention, Usual care with non-sleep provider
Sleep Apnea Clinical Trial 2023: SAM Clinic Intervention Highlights & Side Effects. Trial Name: NCT03835702 — N/A
SAM Clinic Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT03835702 — N/A
~8 spots leftby Dec 2025
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