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ACTIVE NOT RECRUITING
NCT05530967
NA

Assessing the Validity of the PAP Problems Triage Tool in Patients With PAP Treatment for Obstructive Sleep Apnea

Sponsor: Kaiser Permanente

View on ClinicalTrials.gov

Summary

The intended use of the Positive Airway Pressure (PAP) Problems Triaging Tool (TT) is to appropriately triage patients with a PAP-associated problem(s) to a specific intervention(s) based on patient responses. Thus, the proposed research will validate the tool, determine optimal scoring thresholds, and explore the utility of the tool as an indicator for intervention. Our central hypothesis is that the PAP Problems TT will identify treatment barriers that if unaddressed, are predictive of treatment non-adherence.

Official title: Assessing the Structure and Validity of the PAP Problems Triage Tool in Patients With Newly-Initiated PAP Treatment for Obstructive Sleep Apnea

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

355

Start Date

2023-02-08

Completion Date

2026-12

Last Updated

2026-07-21

Healthy Volunteers

Yes

Interventions

OTHER

TT

This intervention uses questionnaire at three-time intervals (i.e., days 5, 10, and 30) and abstraction of PAP use data (days 1 - 35). Consecutive adults with moderate-severe OSA and recommended to PAP treatment will be invited to the study. Once the patient has been prescribed PAP therapy a research associate will call the patient before receiving their new PAP device. The research associate will utilize an IRB approved telephone script to discuss study details, conduct eligibility screening (inclusion/exclusion criteria), and to ask whether the patient is interested in participating. The research associate will then send the patient an IRB approved digital information sheet. The information sheet will provide the patient an option to mark "Yes" if they are willing to participate in the study or "No" if they are not willing. Patients who indicate their willingness to participate will receive the Triage Tool in accordance with the study protocol.

OTHER

VE

A randomly selected sub-group of participants (n=30) will also receive an animated education video that provides targeted information and encouragement for self-managing your PAP problem(s). Patients in this sub-group will be asked to view a maximum of 2 different videos that are less than 2 minutes in duration. These videos are aligned with practice guideline recommendations for addressing PAP problems early in treatment. The videos will be sent digitally from Somnoware™.

Locations (1)

Kaiser Permanente Fontana Sleep Clinic

Fontana, California, United States