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Enhancing PAP Adherence Among Spanish-speaking Hispanic Adults With OSA

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Geisinger Health

Status

Begins enrollment this month

Conditions

Obstructive Sleep Apnea

Treatments

Behavioral: Automated Management (AM)

Study type

Interventional

Funder types

Other

Identifiers

NCT05618444
2022-0810 (Other Identifier)
375-SR-25 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Automated Management (AM)
Experimental group
Description:
Receipt of text-based behavioral intervention
Treatment:
Behavioral: Automated Management (AM)
Usual Care
No Intervention group
Description:
Control group receiving usual care for obstructive sleep apnea

Trial contacts and locations

4

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Central trial contact

Alexa Watach, PhD, RN

Data sourced from clinicaltrials.gov

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