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NCT Number: NCT05618444

Enhancing PAP Adherence Among Spanish-speaking Hispanic Adults With 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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanent Southern California, Fontana, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Automated Management (AM)

Behavioral

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.

Primary outcomes

  1. Patient Satisfaction

    Time frame: 6 months

    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.

  2. Acceptability

    Time frame: 6 months

    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.

  3. Appropriateness

    Time frame: 6 months

    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.

Secondary outcomes

  1. Recruitment Rate

    Time frame: 6 months

    Recruitment Rate computed at the end of the trial

  2. Retention Rate

    Time frame: 6 months

    Retention Rate computed at the end of the trial

Other outcomes

  1. Positive airway pressure (PAP) use from 3-6 months

    Time frame: 3-6 months

    Hours of PAP use per 24 hours

  2. PAP adherence based on modified Centers for Medicare & Medicaid Services (CMS) criteria

    Time frame: 6 months

    Adherence yes/no using ≥4 hours/night and ≥70% of nights

Study contacts

Contact information is provided by the study sponsor or research team.

Alexa Watach, PhD, RN

CONTACT

[email protected]

570-271-8663

Sponsors and collaborators

Lead sponsor

Geisinger Clinic

Other

Collaborators

  • American Academy of Sleep Medicine
  • University of Kansas
  • University of Pennsylvania

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 16, 2022
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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