Obstructive Sleep ApneaNCT05618444
Enhancing PAP Adherence Among Spanish-speaking Hispanic Adults With OSA
A study testing Automated Management (AM) in people with Obstructive Sleep Apnea, run by Geisinger Clinic at 4 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Automated Management (AM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
Geisinger
Danville, Pennsylvania, 17821
Bruno Saconi, PhD
Kaiser Permanent Southern California
Fontana, California, 92335
Dennis X Hwang, MD
University of Kansas Medical Center
Kansas City, Kansas, 66160
Mariana Ramirez, LCSW
Perales Puchalt Jaime, PhD
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Automated Management (AM)
- Keywords
- positive airway pressure (PAP), adherence, Hispanic, tele-management
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated Management (AM)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Automated Management (AM) | Experimental | Receipt of text-based behavioral intervention Receives: Behavioral: Automated Management (AM) |
| Usual Care | No intervention | Control group receiving usual care for obstructive sleep apnea |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (2)
Recruitment Rate
Recruitment Rate computed at the end of the trial
Measured: 6 months
Retention Rate
Retention Rate computed at the end of the trial
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study startSep 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Sleep Medicine, University of Pennsylvania, University of Kansas
- Responsible party
- Sponsor
- Investigators
- Alexa Watach, PhD, RN, Principal investigator, Unniversity of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05618444
- Sponsor's protocol ID
- 2022-0810
- Other IDs
- 375-SR-25
- Status last verified
- May 2026
- First submitted
- 3 Nov 2022
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Positive Airway Pressure (PAP) Adherence Among Spanish-Speaking Hispanic Adults With Obstructive Sleep Apnea (OSA)
- ClinicalTrials.gov ID
- NCT05618444
- Acronym / sponsor ID
- 2022-0810
- Conditions
- Obstructive Sleep Apnea
- Keywords
- positive airway pressure (PAP), adherence, Hispanic, tele-management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Collaborators
- American Academy of Sleep Medicine, University of Pennsylvania, University of Kansas
- Study start
- Sep 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 16 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Automated Management (AM) | Experimental | Behavioral: Automated Management (AM)Receipt of text-based behavioral intervention |
| Usual Care | No intervention | –Control group receiving usual care for obstructive sleep apnea |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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%)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Automated Management (AM) |
Primary outcome
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.
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.
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.
2 secondary outcomes
Recruitment Rate
Time frame: 6 months
Retention Rate
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexa Watach, PhD, RN principal investigator
Unniversity of Pennsylvania
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated Management (AM) in people with Obstructive Sleep Apnea, run by Geisinger Clinic at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexa Watach, PhD, RN (570-271-8663, awatach@nursing.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.