Remote Diagnosis and Management of Obstructive Sleep Apnea

NCT ID: NCT03007745

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 435 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-24
• Study Completion Date: 2021-01-31

Brief Summary

Although obstructive sleep apnea, a breathing disorder during sleep, is prevalent and recognized as a major public health concern, most Veterans with this disorder are undiagnosed and therefore untreated. Access to sleep laboratories for testing is limited particularly for those Veterans living in rural areas and Veterans with disabilities that prevent travel to a sleep center. The goal of this study is to compare a web-based telehealth management strategy to in-person management. The telehealth pathway will enable Veterans to be diagnosed and treated without visiting a sleep center. The investigators believe that telehealth management will increase Veterans' access to this specialized care at a cost that is less than in-person delivery but with similar improvements in daytime function.

Detailed Description

Obstructive sleep apnea (OSA) is estimated to be the third most common chronic disease in Veterans and is associated with an increased risk of hypertension, heart attacks, strokes, depression, and driving accidents. Current in-person management at a sleep center limits Veterans' access to care, prolongs patient wait times, and requires Veterans living in remote areas to travel long distances. This proposal will evaluate an innovative web-based clinical pathway to diagnose and manage Veterans with OSA. In Fiscal Year 13, the investigative team received a Veterans Health Administration (VHA) Innovation Award to create the Remote Veteran Apnea Management Portal (REVAMP), a personalized, interactive website that, when combined with other emerging telehealth technologies, is designed to improve access to care, reduce patient wait times, and allow Veterans to receive care without travelling to a sleep center. Veterans complete intake and follow-up questionnaires on the REVAMP website and perform an unattended home sleep test (HST) without in-person instructions. Sleep specialists review the findings with the patient during an initial phone clinic. REVAMP auto-populates the Veteran's questionnaire responses into templated progress notes that are exported to CPRS, the electronic medical record. Veterans diagnosed with OSA are treated with automatically adjusting positive airway pressure (APAP) units. These devices transmit data wirelessly to the website where treatment use and its effectiveness can be monitored by both Veterans and practitioners, thereby promoting patient self-management and productive patient-practitioner interactions.

The investigators' proposed prospective, randomized intervention will compare the clinical and cost-effectiveness of REVAMP management of Veterans with OSA to in-person care. Aim 1 will determine if management with REVAMP is clinically non-inferior to in-person care in terms of improvement in functional outcomes and APAP adherence. Non-inferiority of clinical effectiveness following 3 months of APAP treatment will be expressed in terms of improvement in the score of the Functional Outcomes of Sleep Questionnaire (FOSQ-10), the investigators' primary outcome measure. Adherence to APAP will be objectively monitored by wireless transmission of data from the participant's home unit. In Aim 2, patient preference, medical service use and cost will be collected every 3 months for the entire observation period to compare cost effectiveness of the two managements. Preference will be assessed by the Short Form-6D (SF 6D), and the EuroQol-5D (EQ-5D). Differences in the ratio of cost and quality-adjusted life years saved by REVAMP compared to in-person management will test the hypothesis that REVAMP management will have lower cost and equivalent outcomes. The results of Aims 1 and 2 will provide evidence to support widespread dissemination of REVAMP. Formative evaluation in Aim 3 will use qualitative (targeted phone interviews) and quantitative measures (attrition, work alliance, and patient satisfaction) to inform clinicians, administrators and other stakeholders how to implement this innovative chronic disease pathway.

Aim 1 (primary). To compare functional outcomes following 3 months of APAP treatment in Veterans with OSA randomized to REVAMP versus in-person management. The primary outcome measure in this modified intent-to-treat analysis (i.e., subjects initiated on APAP with at least one FOSQ follow-up score) will be the change from baseline in the FOSQ-10 score. Analysis will also compare the mean daily hours of APAP use in participants in the two groups initiated on APAP treatment.

Hypothesis 1a: Mean change in FOSQ-10 score among participants randomized to REVAMP management will be no more than one point less than that in participants receiving in-person management.

Hypothesis 1b: Mean daily hours of APAP use among participants receiving REVAMP management will be no more than 0.75 hour less than that in participants randomized to in-person management.

Aim 2 (secondary): To compare the differences in cost and quality-adjusted life years (QALY) between REVAMP management and in-person management. The perspective of the analysis will be that of the VA and the intention to treat analysis set will include all randomized participants.

Hypothesis 2a: Average total health-care delivery cost will be lower for participants receiving REVAMP compared to in-person management.

Hypothesis 2b: The 90% lower limit of cost per QALY ratio comparing in-person versus REVAMP manage-ment will be > $100,000 (i.e., the investigators will have 90% confidence that REVAMP is good value for the cost).

Aim 3 (exploratory): To conduct a mixed methods formative evaluation that will guide REVAMP's widespread implementation. Quantitative component: The investigators will track quantitative outcome measures across both groups including attrition, participant- and practitioner-rated therapeutic alliance (Working Alliance Inventory-Short Revised [WAI-SR]),9 and participant treatment satisfaction (Client Satisfaction Questionnaire [CSQ-8]).10 The investigators will compare the scores of the WAI-SR and CSQ-8 and attrition rates between treatment arms. Qualitative component: The investigators will explore participant- and practitioner-level perspectives, attitudes, and preferences regarding REVAMP versus in-person management, as well as barriers and facilitators to participation in either clinical pathway through phone interviews with participants from the two intervention groups, participants who withdraw from either intervention, and staff who provide care through REVAMP.

Our primary aim was to demonstrate that the efficacy of REVAMP management is not clinically inferior to in-person care. Efficacy was measured as the change in FOSQ-10 score from pretreatment to 3 months following initiation of APAP treatment. An increase of more than 1 point in mean FOSQ score is felt to indicate an important clinical difference. Based on previous studies, we assumed a common SD=2.80. Similar calculations were performed for the APAP adherence outcome based on a non-inferiority delta of -0.75 hr/day and assuming a SD=2.2. 114 participants/group were estimated to be required to achieve at least 85% power to reject the null hypothesis, i.e., find that the change in FOSQ score among patients receiving the telehealth-based management is > 1 point lower than that in participants assessed in-person and that APAP adherence among participants receiving the telehealth-based management is > 0.75 hours lower that that in participants assessed in-person.

Conditions

Sleep Apnea - Obstructive; Cost Effectiveness; Telemedicine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

REVAMP

Veterans randomized to this arm will have access to the Remote Veteran Apnea Management Platform (REVAMP) a personalized, interactive website that allows Veterans to be evaluated for OSA without travelling to the sleep center.

Group Type: EXPERIMENTAL

autoadjusting continuous positive airway pressure

Intervention Type: DEVICE

Participants in both arms who are diagnosed with obstructive sleep apnea will be treated with autoadjusting continuous positive airway pressure

In-person management

Veterans randomized to this arm will receive standard in-person management of their sleep apnea in the sleep center.

Group Type: ACTIVE_COMPARATOR

autoadjusting continuous positive airway pressure

Intervention Type: DEVICE

Participants in both arms who are diagnosed with obstructive sleep apnea will be treated with autoadjusting continuous positive airway pressure

Interventions

autoadjusting continuous positive airway pressure

Participants in both arms who are diagnosed with obstructive sleep apnea will be treated with autoadjusting continuous positive airway pressure

Intervention Type: DEVICE

Other Intervention Names

APAP

Eligibility Criteria

Inclusion Criteria

• Referral to one of the participating sleep centers for evaluation of suspected OSA
• Access in the home to the internet, e-mail, and phone on all days
• Fluent in English as assessed on the initial phone contact

Exclusion Criteria

Veterans will be excluded from the study for the following reasons:

• Unable or unwilling to provide informed consent and complete required questionnaires
• Previous diagnosis of:

• obstructive sleep apnea (OSA)
• central sleep apnea (50% of apneas on diagnostic testing are central apneas)
• Cheyne-Stokes breathing
• obesity hypoventilation syndrome
• narcolepsy
• Previous treatment with positive airway pressure, non-nasal surgery for OSA, or current use of supplemental oxygen
• A clinically unstable medical condition in the previous 2 months as defined by a new diagnosis, e.g.:

• pneumonia
• myocardial infarction
• congestive heart failure
• unstable angina
• thyroid disease
• depression or psychosis
• ventricular arrhythmias
• cirrhosis
• surgery
• recently diagnosed cancer
• Night shift workers in situations or occupations where they regularly experience jet lag, or have irregular work schedules by history over the last 3 months
• Women who are pregnant or women who are sexually active and of child-bearing age who are not using some form of contraceptive
• Unable to perform tests due to inability to communicate verbally, inability to read and write, and visual, hearing or cognitive impairment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Samuel T. Kuna, MD

Role: PRINCIPAL_INVESTIGATOR

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Locations

VA San Diego Healthcare System, San Diego, CA

San Diego, California, United States

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, United States

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, United States

Countries

United States

References

Chang YHA, Folmer RL, Shasha B, Shea JA, Sarmiento K, Stepnowsky CJ, Lim D, Pack A, Kuna ST. Barriers and facilitators to the implementation of a novel web-based sleep apnea management platform. Sleep. 2021 Apr 9;44(4):zsaa243. doi: 10.1093/sleep/zsaa243.

Reference Type: BACKGROUND

PMID: 33216916 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IIR 12-409

Identifier Type: -

Identifier Source: org_study_id