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Behavioral Intervention

Automated Management for Sleep Apnea

N/A
Recruiting
Led By Bruno Saconi, PhD
Research Sponsored by Geisinger Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Referred to PAP treatment and able and willing to be treated with PAP
Moderate-severe OSA defined as AHI ≥15 events/hour using a hypopnea criterion of a 4% oxygen desaturation (AHI4%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-6 months
Awards & highlights

Study Summary

This trial aims to help Spanish-speaking Hispanics with Obstructive Sleep Apnoea (OSA) to better adhere to positive airway pressure (PAP) treatment. A tele-management intervention will be used.

Who is the study for?
This trial is for Spanish-speaking Hispanic adults over 18 with moderate to severe obstructive sleep apnea (OSA), who are starting PAP therapy and own a smartphone with texting. It's not for those planning weight loss surgery, have other respiratory conditions, need extra oxygen, or women referred to PAP due to pregnancy-related OSA.Check my eligibility
What is being tested?
The study tests a tele-management intervention called Automated Management (AM) designed specifically for Spanish-speaking Hispanics with OSA. The goal is to see if AM can improve long-term use of positive airway pressure (PAP) machines in this group.See study design
What are the potential side effects?
Since the intervention involves management and support rather than medication, direct side effects are not expected. However, general side effects related to PAP treatment may include discomfort, nasal congestion, dry mouth or throat.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am referred for and agree to undergo PAP treatment.
Select...
I have moderate to severe sleep apnea with an AHI of 15 or more.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Recruitment Rate
Retention Rate
Other outcome measures
Acceptability
Appropriateness
PAP adherence based on modified Centers for Medicare & Medicaid Services (CMS) criteria
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Automated Management (AM)Experimental Treatment1 Intervention
Receipt of text-based behavioral intervention
Group II: Usual CareActive Control1 Intervention
Control group receiving usual care for obstructive sleep apnea

Find a Location

Who is running the clinical trial?

American Academy of Sleep MedicineOTHER
22 Previous Clinical Trials
2,588 Total Patients Enrolled
Geisinger ClinicLead Sponsor
149 Previous Clinical Trials
1,886,085 Total Patients Enrolled
Bruno Saconi, PhDPrincipal InvestigatorGeisinger Clinic

Media Library

Automated Management (AM) (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05618444 — N/A
Obstructive Sleep Apnea Research Study Groups: Automated Management (AM), Usual Care
Obstructive Sleep Apnea Clinical Trial 2023: Automated Management (AM) Highlights & Side Effects. Trial Name: NCT05618444 — N/A
Automated Management (AM) (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05618444 — N/A

Frequently Asked Questions

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

Are there any open enrollments for this clinical trial?

"According to the clinicaltrials.gov database, this trial is no longer accepting patients; with initial posting date being on 1/10/2023 and last edited on 11/8/2022. Fortunately, there are 282 other trials currently enrolling participants for their respective studies."

Answered by AI

How many sites are implementing this research endeavor?

"Currently, 4 medical institutions are recruiting patients for this trial: Geisinger in Danville, University of Pennsylvania in Philadelphia, Kaiser Permanent Southern California in Fontana, and another four sites."

Answered by AI

Who else is applying?

What site did they apply to?
Kaiser Permanent Southern California
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I have diagnosed with sleep apnea and i want to see if i can better it.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Enhancing PAP Adherence Among Spanish-speaking Hispanic Adults With OSA
2023. "Enhancing PAP Adherence Among Spanish-speaking Hispanic Adults With OSA". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05618444.
~33 spots leftby May 2026
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