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SAM Clinic Intervention for Sleep Apnea

N/A

Waitlist Available

Led By Reena Mehra, MD

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 3 month follow up

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 3 month follow up

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Daytime Somnolence

Depressive Symptoms

Fatigue

+2 more

Other outcome measures

Masks

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor

1,030 Previous Clinical Trials

1,363,962 Total Patients Enrolled

3 Trials studying Sleep Apnea

676 Patients Enrolled for Sleep Apnea

ResMedIndustry Sponsor

135 Previous Clinical Trials

43,706 Total Patients Enrolled

9 Trials studying Sleep Apnea

4,134 Patients Enrolled for Sleep Apnea

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What exactly is this research striving to achieve?

"The primary aim of this clinical trial, to be measured over the duration from baseline to 3 months post-treatment is evaluating percent days of PAP use in the prior 4 weeks and at 12 weeks. Additional objectives include comparing changes between SAM Clinic and usual care arms regarding patient reported outcomes such as depression (measured by PHQ-9), fatigue (using PROMIS Fatigue) and sleep impairment (utilizing PROMIS Sleep Related Impairment). It is hypothesized that those receiving treatment in the SAM Clinic intervention will demonstrate greater improvement compared to their counterparts under conventional methods."

Answered by AI

How extensive is the sample size of participants involved in this clinical trial?

"Correct. Data hosted on clinicaltrials.gov attests that this medical trial, which was first posted on April 1st 2019, is actively searching for participants. Approximately 166 patients must be enlisted from one location in particular."

Answered by AI

Is enrollment currently open for this research study?

"The trial is presently open to patient recruitment, as per clinicaltrials.gov; this research was posted on April 1st 2019 and last edited on May 3rd 2022."

Answered by AI

Recent research and studies

Journal of Clinical Sleep MedicineJournal

Impact of Sleep-disordered Breathing Treatment on Quality of Life Measures in a Large Clinic-based Cohort

Walia, Harneet K., Nicolas R. Thompson, Irene Katzan, Nancy Foldvary-Schaefer, Douglas E. Moul, and Reena Mehra. 2017. “Impact of Sleep-disordered Breathing Treatment on Quality of Life Measures in a Large Clinic-based Cohort”. Journal of Clinical Sleep Medicine. American Academy of Sleep Medicine (AASM). doi:10.5664/jcsm.6792.

American Journal of Obstetrics and GynecologyJournal

Validity and Utility of the PRIME-MD Patient Health Questionnaire in Assessment of 3000 Obstetric-gynecologic Patients: The PRIME-MD Patient Health Questionnaire Obstetrics-gynecology Study

Spitzer, Robert L., Janet B.W. Williams, Kurt Kroenke, Raymond Hornyak, and Julia McMurray. 2000. “Validity and Utility of the PRIME-MD Patient Health Questionnaire in Assessment of 3000 Obstetric-gynecologic Patients: The PRIME-MD Patient Health Questionnaire Obstetrics-gynecology Study”. American Journal of Obstetrics and Gynecology. Elsevier BV. doi:10.1067/mob.2000.106580.

Controlled Clinical TrialsJournal

Introduction to Sample Size Determination and Power Analysis for Clinical Trials

Lachin, John M.. 1981. “Introduction to Sample Size Determination and Power Analysis for Clinical Trials”. Controlled Clinical Trials. Elsevier BV. doi:10.1016/0197-2456(81)90001-5.

SleepJournal