Improving PAP adherence for Spanish-speaking Hispanic adults with sleep apnea
Enhancing Positive Positive Airway Pressure (PAP) Adherence Among Spanish-Speaking Hispanic Adults With Obstructive Sleep Apnea (OSA)
This study is testing a new phone-based support program to help Spanish-speaking Hispanic adults with sleep apnea stick to their PAP therapy and improve their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Geisinger Clinic Academic / other |
| Locations | 4 sites (Fontana, California and 3 other locations) |
| Trial ID | NCT05618444 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance long-term adherence to positive airway pressure (PAP) therapy among Spanish-speaking Hispanic adults suffering from obstructive sleep apnea (OSA). It will evaluate the feasibility and effectiveness of a culturally and linguistically adapted tele-management intervention called Automated Management (AM). The intervention includes education, support, and motivational enhancement delivered through tele-messaging, tailored to individual PAP use and behavioral profiles. By addressing barriers such as distance and transportation, this approach seeks to provide equitable access to quality care and improve health outcomes for this underserved population.
Who should consider this trial
Good fit: Ideal candidates are Spanish-speaking Hispanic adults aged 18 and older with moderate to severe obstructive sleep apnea.
Not a fit: Patients with other types of sleep apnea or those requiring supplemental oxygen or non-invasive ventilation may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve PAP adherence and health outcomes for Spanish-speaking Hispanic adults with OSA.
How similar studies have performed: Other studies have shown success with culturally tailored interventions for improving adherence in diverse populations, suggesting potential for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Spanish-speaking and reading * Self-identified Hispanic * Adults ≥ 18 years-old * Males and females * Moderate-severe OSA defined as AHI ≥15 events/hour using a hypopnea criterion of a 4% oxygen desaturation (AHI4%) * Expected availability for the duration of the study (6 months from date of randomization) * Ownership of smartphone with unlimited text messaging capability * Referred to PAP treatment and able and willing to be treated with PAP Exclusion Criteria: * Other sleep apnea or nocturnal respiratory insufficiency or failure diagnosis other than OSA established by polysomnogram (PSG) or home sleep apnea test (HSAT) * Requirement of supplemental oxygen or other non-invasive ventilation modality * Women referred to PAP because of new-onset OSA with pregnancy as PAP treatment may be time-limited (enrolled women who become pregnant during the trial and are already on PAP treatment will not be excluded) * Anticipated or scheduled bariatric surgery and/or referred to sleep evaluation by bariatric surgery
Where this trial is running
Fontana, California and 3 other locations
- Kaiser Permanent Southern California — Fontana, California, United States (Recruiting)
- University of Kansas Medical Center — Kansas City, Kansas, United States (Recruiting)
- Geisinger — Danville, Pennsylvania, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Bruno Saconi, PhD — Geisinger Clinic
- Study coordinator: Bruno Saconi, PhD
- Email: bsaconi@geisinger.edu
- Phone: 5702148191
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.