Document text
Principal Investigator: Cathy Ann Alessi
Organization: VA GREATER LOS ANGELES HEALTHCARE SYSTEM
Fiscal Year: 2024
Funding agency: Veterans Affairs
Background: The most frequently diagnosed sleep disorder among older Veterans is obstructive sleep apnea
(OSA), which is associated with serious adverse effects on health, quality of life and survival. Positive airway
pressure (PAP) is recommended as first-line treatment (particularly for moderate to severe OSA), but
sustained use is difficult to achieve, including among older Veterans, and nearly half of patients with OSA who
begin PAP therapy discontinue use within a year.
Significance/Impact: Although OSA is a chronic condition, research to date has primarily focused on increasing
initial PAP use in patients with newly diagnosed OSA. In addition, most research has not addressed PAP use
in older adults, which is unfortunate given the high prevalence and important adverse effects of OSA on their
health and well-being. Prior work suggests that behavioral interventions are effective in improving initial PAP
use, but little is known of how to address insufficient use over time.
Innovation: To address this problem, we developed and pilot-tested a structured, manual-based approach to
address insufficient PAP use among older adults with previously diagnosed OSA. The intervention (5 sessions
over 8 weeks, then monthly contact for up to 6 months) is designed so it can be provided by individuals (“sleep
coaches”) from various disciplines (supervised remotely by a psychologist) in a variety of settings for maximal
implementation. Core components of the intervention include: 1) educational and behavioral approaches to
improve PAP use, 2) individualized self-management and troubleshooting techniques to address factors
contributing to insufficient PAP use, and 3) ongoing review of objective PAP use (via remote monitoring).
Specific Aims: Primary Aim 1 will test the efficacy of this intervention for improving PAP usage among older
Veterans with previously diagnosed OSA who have insufficient PAP use. Our hypotheses are that the
intervention will increase objectively measured PAP use at 6-months follow-up, with effects sustained at 12
months. Secondary Aim 2 will test for effects on sleep quality, daytime sleepiness and sleep-related function;
and Exploratory Aim 3 will test for effects on health-related quality of life. Our hypotheses are that these
outcomes will also improve at 6 months, and effects will be sustained at 12 months.
Methodology: We propose a randomized, controlled trial to test this new intervention in older Veterans (aged >
65 years, N=90) with previously diagnosed OSA (moderate to severe) who were prescribed PAP 1-5 years in
the past, but have insufficient PAP use (defined as no PAP use over the prior 30 days). Given prior growing
interest in telehealth and remote monitoring approaches to optimize PAP use, and the ongoing COVID-19
pandemic, all aspects of the study will be performed virtually in keeping with the latest VA COVID-era guidance
for the remote testing and treatment of OSA. Participants will be randomized to the intervention or a control
program that mirrors “optimal usual care” for OSA plus general sleep education (attention control). Structured
assessments at baseline, post-treatment (after session 5) and 6- and 12-months follow-up include objectively
measured PAP use (via remote telemonitoring), sleep quality (Pittsburgh Sleep Quality Index), daytime
sleepiness (Epworth Sleepiness Scale), sleep-related function (Functional Outcomes of Sleep-10) and health-
related quality of life (PROMIS-29 v2.1 Physical and Mental Health Summary Scores). We will collect
participant experiences and attitudes related to the intervention, and implementation outcome measures
(acceptability, appropriateness, fidelity and staff time as an estimate of cost) to inform future implementation.
Implementation/Next Steps: The long-term goal of this work is to effectively address insufficient PAP use
among older Veterans with OSA to improve their health and quality of life. If successful, we will implement the
intervention at our institution, and develop and disseminate an implementation package with actual tools
needed to promote wider implementation of this model of care into clinical practice.
Terms: <65 and older><65 or older><65 years of age and older><65 years of age or more><65 years of age or older><65+ years><65+ years old><> 65 years><Active Follow-up><Address><Adverse effects><After Care><After-Treatment><Aftercare><Aged 65 and Over><Area><Attitude><Behavior Conditioning Therapy><Behavior Modification><Behavior Therapy><Behavior Treatment><Behavioral><Behavioral Conditioning Therapy><Behavioral Modification><Behavioral Therapy><Behavioral Treatment><COVID crisis><COVID epidemic><COVID pandemic><COVID-19 crisis><COVID-19 epidemic><COVID-19 era><COVID-19 global health crisis><COVID-19 global pandemic><COVID-19 health crisis><COVID-19 pandemic><COVID-19 period><COVID-19 public health crisis><COVID-19 years><Cardiovascular Diseases><Caring><Chronic><Clinical><Cognitive Disturbance><Cognitive Impairment><Cognitive decline><Cognitive function abnormal><Conditioning Therapy><Data><Data Systems><Diabetes Mellitus><Diagnosis><Discipline><Disease><Disorder><Disturbance in cognition><Drowsiness><Education><Educational aspects><Equipment><Functional impairment><Goals><Health><Health Care Systems><Healthcare Systems><High Prevalence><Hour><Hypertension><Hypoxia><Hypoxic><IT Systems><Impaired cognition><Individual><Information Systems><Information Technology Systems><Institution><Intervention><Intervention Strategies><Left><Manuals><Measurement><Measures><Mental Depression><Mental Health><Mental Hygiene><Methodology><Modeling><Newly Diagnosed><Obstructive Sleep Apnea><Outcome><Outcome Measure><Oxygen Deficiency><Participant><Patient Outcomes Assessments><Patient Reported Measures><Patient Reported Outcomes><Patients><Personal Satisfaction><Phone><Pittsburgh Sleep Quality Index><Prevalence><Provider><Psychological Health><Psychologist><QOL><Quality of life><Randomized><Randomized, Controlled Trials><Recommendation><Reporting><Research><Risk><SARS-CoV-2 epidemic><SARS-CoV-2 global health crisis><SARS-CoV-2 global pandemic><SARS-CoV-2 pandemic><SARS-coronavirus-2 epidemic><SARS-coronavirus-2 pandemic><Self Management><Services><Severe Acute Respiratory Syndrome CoV 2 epidemic><Severe Acute Respiratory Syndrome CoV 2 pandemic><Severe acute respiratory syndrome coronavirus 2 epidemic><Severe acute respiratory syndrome coronavirus 2 pandemic><Sleep><Sleep Apnea><Sleep Apnea Syndromes><Sleep Deprivation><Sleep Disorders><Sleep Fragmentations><Sleep Hypopnea><Sleep-Disordered Breathing><Somnolence><Structure><Syndrome, Sleep Apnea, Obstructive><Techniques><Telephone><Testing><Time><Treatment Efficacy><Vascular Hypertensive Disease><Vascular Hypertensive Disorder><Veterans><Work><above age 65><active followup><adverse consequence><adverse outcome><after age 65><age 65 and greater><age 65 and older><age 65 or older><age > 65><age of 65 years onward><aged 65 and greater><aged 65+><aged ≥65><airflow limitation><airflow obstruction><airway limitation><airway obstruction><attentional control><behavior intervention><behavioral intervention><cardiovascular disorder><care as usual><clinical practice><cognitive dysfunction><cognitive loss><compare to control><comparison control><coronavirus disease 2019 crisis><coronavirus disease 2019 epidemic><coronavirus disease 2019 global health crisis><coronavirus disease 2019 global pandemic><coronavirus disease 2019 health crisis><coronavirus disease 2019 pandemic><coronavirus disease 2019 public health crisis><coronavirus disease crisis><coronavirus disease epidemic><coronavirus disease pandemic><coronavirus disease-19 global pandemic><coronavirus disease-19 pandemic><cost estimate><cost estimation><deficient sleep><depression><design><designing><diabetes><effective intervention><efficacy testing><experience><follow up><follow-up><followed up><followup><functional outcomes><future implementation><health related quality of life><high blood pressure><human old age (65+)><hyperpiesia><hyperpiesis><hypertensive disease><hypertensive disorder><implementation outcomes><improved><improvement on sleep><inadequate sleep><innovate><innovation><innovative><insufficient sleep><interest><intervention efficacy><interventional strategy><measurable outcome><new approaches><novel><novel approaches><novel strategies><novel strategy><obstructed airflow><obstructed airway><old age><older adult><older adulthood><outcome measurement><outreach><over 65 years><physical conditioning><physical health><pilot test><positive airway pressure><post treatment><primary outcome><programs><quality of sleep><randomisation><randomization><randomized control trial><randomly assigned><remote care><remote grading><remote health care><remote healthcare><remote monitoring><remote review><remote testing><remote therapist><remote therapy><remote treatment><respiratory airway obstruction><severe acute respiratory syndrome coronavirus 2 global health crisis><severe acute respiratory syndrome coronavirus 2 global pandemic><sleep debt><sleep deficiency><sleep deficit><sleep diseases><sleep dysfunction><sleep illness><sleep improvement><sleep insufficiency><sleep loss><sleep problem><sleep quality><sleep-related breathing disorder><sleepiness><stroke recovery><telehealth><telemonitoring><therapeutic efficacy><therapy efficacy><tool><treatment as usual><usual care><virtual><well-being><wellbeing><≥65 years>