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Enhancing PAP Adherence Among Spanish-speaking Hispanic Adults With OSA

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Geisinger Health

Status

Enrolling

Conditions

Obstructive Sleep Apnea

Treatments

Behavioral: Automated Management (AM)

Study type

Interventional

Funder types

Other

Identifiers

NCT05618444
2022-0810 (Other Identifier)

Details and patient eligibility

About

This study seeks to enhance long-term positive airway pressure (PAP) adherence among Spanish-speaking Hispanics, 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 Hispanics, a group with known PAP outcomes disparities. This study will assess the feasibility, usability and 6-month effectiveness of a linguistically and culturally adapted efficacious 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 two-way, interactive communication is algorithmic based on PAP use and behavioral profiles defined at baseline. The innovative, technology-based interventions are 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 long-term PAP management that may mitigate known PAP adherence disparities for minority adults with OSA. If effective for long-term 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

Bruno Saconi, PhD

Data sourced from clinicaltrials.gov

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