← Back to Search

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%)
Must not have
Requirement of supplemental oxygen or other non-invasive ventilation modality
Other sleep apnea or nocturnal respiratory insufficiency or failure diagnosis other than OSA established by polysomnogram (PSG) or home sleep apnea test (HSAT)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-6 months
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I need extra oxygen or a device to help me breathe.
Select...
I have a sleep disorder diagnosed other than OSA, confirmed by a sleep study.

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

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

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: 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
25 Previous Clinical Trials
2,840 Total Patients Enrolled
Geisinger ClinicLead Sponsor
155 Previous Clinical Trials
1,978,579 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
~26 spots leftby May 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top