Suspended

Predictive Analytics and Peer-Driven Intervention for Guideline-based Care for Sleep Apnea

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What is being tested

Peer-Buddy System

+ Usual Care

Other
Who is being recruted

Apnea+6

+ Nervous System Diseases

+ Respiration Disorders

From 21 to 85 Years
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: November 2017
See protocol details

Summary

Principal SponsorUniversity of Arizona
Study ContactSairam Parthasarathy, MD
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 17, 2017

Actual date on which the first participant was enrolled.

OSA affects 7 to 12% of the US population and is an independent risk factor for several clinical consequences such as systemic hypertension, cardiovascular disease, stroke, reduced HR-QOL, increased all-cause mortality, and motor vehicle accidents due to sleepiness. However, OSA and other sleep disorders are woefully underdiagnosed because of time constraints at the PCP's office. Such poor CPAP adherence is associated with increased risk for fatal and non-fatal cardiovascular events. CPAP therapy has been associated with up to 3-fold reduction in fatal and non-fatal cardiovascular events in both on-treatment analysis of RCTs and observational studies. CPAP therapy is associated with 7-fold reduction in sleepiness-related accidents. The overarching aim of this proposal is to institute a multi-level strategy aimed at improving guideline based care for OSA in populations with health disparities. The overarching aim of the program of research is to eventually institute a multi-level strategy with interventions aimed at both providers and patients in order to improve guideline based care for OSA in populations with health disparities. Specifically, in order to address the under-diagnosis of OSA, an electronic health record (EHR) based predictive analytics system will be implemented. A similar EHR-based alert system with reflex order sets for initiating testing for OSA that the investigators have developed will enable PCPs to effectively diagnose and treat OSA. It was found that in a nationally representative dataset of \~220,000 patients, lower neighborhood income was associated with lower CPAP adherence. Considering the time and access-related barriers in the PCP office, it is believed that such socioeconomic status (SES) related differences in CPAP adherence needs to be addressed by culturally-competent peer educators (such as promotors) with OSA serving as "peer-buddies". In a recent multi-site RCT, it was found that CPAP adherence and patient satisfaction was improved by peer-driven intervention through an interactive voice response system (PDI-IVR; PCORI-IHS-1306-02505), whereby the peers shared their experiences with CPAP naïve patients and educated them about OSA and risks of CPAP nonadherence. Whether PDI-IVR can improve adherence in underserved population in low resource clinics is unclear. In this proposal, 110 CPAP naïve patients and 35 experienced peer-buddies will be recruited in from a large healthcare system that provides care for an underserved population with an excess burden of sleep disorders (Medicaid and dual-eligible Medicare beneficiaries). This study will address health disparities in the diagnosis and treatment of OSA using a patient-level educational intervention (PDI-IVR system) targeting patients and thereby promote health equity. This proposal will also inform future studies by gathering additional data on the effect of PDI-IVR on adherence to sleep study testing and CPAP adherence in an underserved population in low resource clinics. Specific Aim #1: To test a peer-driven intervention with interactive voice response (PDI-IVR) system to improve adherence to sleep study testing in a lower socioeconomic population. Hypothesis #1: A PDI-IVR support system will lead to greater adherence to sleep study testing in patients with OSA when compared to patients receiving conventional education. Specific Aim #2: To test a peer-driven intervention with interactive voice response (PDI-IVR) system to improve CPAP treatment adherence in a lower socioeconomic population. Hypothesis #2: A PDI-IVR support system will lead to greater adherence to CPAP therapy in patients with OSA when compared to patients receiving conventional education.

Official TitlePredictive Analytics and Peer-Driven Intervention for Guideline-based Care for Sleep Apnea
NCT03345524
Principal SponsorUniversity of Arizona
Study ContactSairam Parthasarathy, MD
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

145 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 21 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ApneaNervous System DiseasesRespiration DisordersRespiratory Tract DiseasesSleep Apnea SyndromesSleep Wake DisordersSleep Apnea, ObstructiveSleep Disorders, IntrinsicDyssomnias

Criteria

Inclusion Criteria for Subject: * Referral for sleep study testing for possible OSA * Medicaid and dual-eligible Medicare beneficiaries * Household income in the bottom national quartile of household median income Inclusion Criteria for Peer Buddy: * Adherent to CPAP therapy (greater than or equal to 4 hours per night of CPAP use) * Willing to meet with peer-buddy on 2-4 occasions in-person * Has a cell phone or other reliable telephone line * Willing to undergo one-two training and orientation session(s) and pass a subsequent mock patient interaction Exclusion Criteria for Subject: * Central sleep apnea (CSA) * Participation in another intervention-based research study * Patient's primary care provider refuses patient participation for medical instability Exclusion Criteria for Peer Buddy: * Central sleep apnea (CSA) * Participation in another intervention-based research study * Patient's primary care provider refuses patient participation for medical instability * Major depression or other major psychiatric illness * Shift-worker or frequent out of town traveler

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Will meet with peer-buddy who will help with them with CPAP usage. Also will receive standard of care CPAP educational training

Group II

Active Comparator
Will receive educational material at the same frequency that those in the experimental arm. Will also receive standard of care CPAP educational training.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Arizona

Tucson, United StatesOpen University of Arizona in Google Maps
SuspendedOne Study Center