Enhancing PAP Adherence Among Spanish-speaking Hispanic Adults With OSA

Enhancing Positive Airway Pressure (PAP) Adherence Among Spanish-Speaking Hispanic Adults With Obstructive Sleep Apnea (OSA)

This study seeks to enhance long-term positive airway pressure (PAP) adherence among Spanish-speaking Hispanic adults, a group with known PAP outcomes disparities. This study will assess the feasibility of a linguistically and culturally adapted tele-management intervention (Automated Management, AM) for Spanish-speaking Hispanic adults with OSA.

Study Overview

• Status: Not yet recruiting
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Behavioral: Automated Management (AM)

Detailed Description

This feasibility study seeks to enhance long-term positive airway pressure (PAP) adherence among Spanish-speaking Hispanic adults, a group with known PAP outcomes disparities. This study will assess the feasibility, usability and effectiveness of a linguistically and culturally adapted tele-management intervention (Automated Management, AM) for Spanish-speaking Hispanic adults with obstructive sleep apnea (OSA) (N=50). A prospective, randomized, parallel group, unblinded, feasibility trial is proposed. AM is a tele-management strategy that includes evidence-based components for improving shorter-term PAP adherence consisting of education, support and troubleshooting, and brief targeted motivational enhancement delivered by tele-messaging. The automated, interactive communication is algorithmic based on PAP use and behavioral profiles defined at baseline. The innovative, technology-based intervention is designed to ensure access to sustained care that overcomes barriers such as distance/geography, transportation limitations or lost work/productivity time. As such, AM can provide equitable access to quality PAP management that may mitigate known PAP adherence disparities for minority adults with OSA. If effective for PAP adherence, these strategies may alter OSA care paradigms, improve outcomes and associated healthcare costs, and reduce disparities.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexa Watach, PhD, RN; Phone Number: 570-271-8663; Email: awatach@nursing.upenn.edu

Study Locations

• United States
  • California
    • Fontana, California, United States, 92335
      • Kaiser Permanent Southern California
      • Principal Investigator: Dennis X Hwang, MD
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
      • Principal Investigator: Mariana Ramirez, LCSW
      • Sub-Investigator: Perales Puchalt Jaime, PhD
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17821
      • Geisinger
      • Principal Investigator: Bruno Saconi, PhD
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
      • Principal Investigator: Amy M Sawyer, PhD
      • Sub-Investigator: A J Watach, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Automated Management (AM); Receipt of text-based behavioral intervention	Behavioral: Automated Management (AM); A tele-management intervention that will deliver text messages to participants via a bot - a computer program that simulates human outreach activity. Programmed messages will address evidence based intervention components for positive airway pressure (PAP) adherence, including PAP use awareness (tele-monitoring), support and troubleshooting, education, and brief motivational messaging.
No Intervention: Usual Care; Control group receiving usual care for obstructive sleep apnea

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction	Satisfaction with quality of care and the components of care (e.g., feedback, frequency, duration), relevance of the care to the individual and their needs, and overall satisfaction with care. Assessed with the Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 scores range from 8 to 32, with higher values indicating higher satisfaction.	6 months
Acceptability	Defined as the perception that a given treatment is agreeable, palatable, or satisfactory. Assessed with the Acceptability of Intervention Measure (AIM; 4 items, Likert, 1-5, where 1 = "completely disagree" and 5 = "completely agree"). Higher scores indicate higher acceptability.	6 months
Appropriateness	Defined as the perceived fit, relevance, or compatibility of a given treatment. Assessed with the Intervention Appropriateness Measure (IAM; 4 items, Likert, 1-5, where 1 = "completely disagree" and 5 = "completely agree"). Higher scores indicate higher appropriateness.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment Rate	Recruitment Rate computed at the end of the trial	6 months
Retention Rate	Retention Rate computed at the end of the trial	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive airway pressure (PAP) use from 3-6 months	Hours of PAP use per 24 hours	3-6 months
PAP adherence based on modified Centers for Medicare & Medicaid Services (CMS) criteria	Adherence yes/no using ≥4 hours/night and ≥70% of nights	6 months

Collaborators and Investigators

• Sponsor: Geisinger Clinic
• Collaborators: University of Pennsylvania; University of Kansas; American Academy of Sleep Medicine
• Investigators: Principal Investigator: Alexa Watach, PhD, RN, Unniversity of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: November 3, 2022
• First Submitted That Met QC Criteria: November 8, 2022
• First Posted (Actual): November 16, 2022

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: adherence; Hispanic; positive airway pressure (PAP); tele-management
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: 2022-0810 (UW Madison); 375-SR-25 (Other Grant/Funding Number: American Academy of Sleep Medicine Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No