Enhancing PAP Adherence Among Spanish-speaking Hispanic Adults With OSA

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05618444
• Other study ID #: 2022-0810
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2023
• Est. completion date: May 30, 2026

Study information

• Verified date: February 2024
• Source: Geisinger Clinic
• Contact: Bruno Saconi, PhD
• Phone: 5702148191
• Email: bsaconi[@]geisinger.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 30, 2026
• Est. primary completion date: May 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Behavioral:
• Automated Management (AM)
A tele-management intervention that will deliver two-way messages to participants via a bot - a computer program that simulates human activity. Programmed AM 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.

Locations

Country	Name	City	State
United States	Geisinger	Danville	Pennsylvania
United States	Kaiser Permanent Southern California	Fontana	California
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Geisinger Clinic	American Academy of Sleep Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Positive airway pressure (PAP) use from 3-6 months	Hours of PAP use per 24 hours	3-6 months
Other	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
Other	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.	1 month
Other	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.	3 months
Other	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.	1 month
Other	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.	3 months
Other	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.	1 month
Other	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.	3 months
Primary	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
Primary	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
Primary	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	Recruitment Rate	Recruitment Rate computed at the end of the trial	6 months
Secondary	Retention Rate	Retention Rate computed at the end of the trial	6 months