Clinical trial NCT05530967: Assessing the Validity of the PAP Problems Triage Tool in Patients With PAP Treatment for Obstructive Sleep Apnea
Official title: Assessing the Structure and Validity of the PAP Problems Triage Tool in Patients With Newly-Initiated PAP Treatment for Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Sleep Apnea (OSA)
Keywords: Positive Airway Pressure (PAP) Therapy
Triaging Tool
PAP Problems
PAP Adherence
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 375
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: This study is a one-group observational design that uses a TT questionnaire and abstraction of PAP use data from a clinically available interface (Somnoware™). Consecutive adults with OSA and recommended to PAP treatment at the Fontana Medical Sleep Center will be invited to the study. Once the patient has been prescribed PAP therapy and has indicated their willingness to participate the TT will be sent digitally from Somnoware™. Participants will receive the TT in accordance to the next time interval defined by the study protocol. A randomly selected sub-group of participants will automatically receive an animated education video delivered digitally from Somnoware™. These videos will provide targeted information for self-managing the endorsed PAP problem.

Diagnostic polysomnogram (PSG) or home sleep apnea test (HSAT) data will be abstracted from Somnoware™. Daily PAP data will be abstracted from Somnoware™ for the first 35-days of PAP use. Demographic data will also be abstracted at day 35 (from the patient's clinical intake questionnaire and electronic health record).

Eligibility criteria: Inclusion Criteria:

* Kaiser Permanente Member (KP insured)
* OSA diagnosis by polysomnogram or Home Sleep Apnea Test with Apnea Hypopnea Index ≥ 15 events/hour
* PAP naïve
* Able to consent to participate
* Fluent or proficient with English
* Accepts PAP for home treatment

Exclusion Criteria:

* Chronic respiratory failure requiring Oxygen supplementation
* PAP device other than a PAP or AutoPAP (i.e., bilevel PAP)
* Pregnant

Primary outcomes:
measure: Factor Analysis
timeFrame: 30 days
measure: Triaging Tool Validity
timeFrame: 30 days
measure: Triaging Tool Predictive Validity
timeFrame: 30 days
Secondary outcomes:
measure: Changes in PAP Use Utilizing Video Education
timeFrame: 5 days
Other outcomes:
Locations:
Study officials:
affiliation: Kaiser Permanente
name: Dennis Hwang, MD
role: PRINCIPAL_INVESTIGATOR
References: