Remote Diagnosis and Management of Obstructive Sleep Apnea

NCT03007745 | Completed Results FDA Device

• 1 other identifier: IIR 12-409
• Study Type: interventional
• Target: 435
• Locations: 1 country
• Sites: 3

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.

Conditions

Sleep Apnea - Obstructive; Cost Effectiveness; Telemedicine

Keywords

Continuous positive airway pressure

Outcome Measures

Primary Outcomes (1)

• Functional Outcome of Sleep Questionnaire - Short Form (FOSQ-10)

  FOSQ-10 score ranges between 5 and 20 units; there is not threshold for normality; a higher score indicates higher functional outcome. Outcome Measure: Change from baseline in Functional Outcome of Sleep Questionnaire - Short Form (FOSQ-10), a self-administered disease specific quality of life questionnaire, in participants initiated on CPAP and receiving a 3-month follow-up (LOCF applied using 1-month data). A change in 1 unit is felt to indicate clinical significance.

  3 months

Secondary Outcomes (9)

• Epworth Sleepiness Scale (ESS)

  3 months

• Heath Survey Short Form - 12 (SF-12) Physical Component

  3 months

• Center for Epidemiological Studies Depression Questionnaire (CES-D)

  3 months

• Insomnia Severity Index (ISI)

  3 months

• Health Utilities Index (HUI)

  3 months

Study Arms (2)

REVAMP

EXPERIMENTAL

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.

Device: autoadjusting continuous positive airway pressure

In-person management

ACTIVE COMPARATOR

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

Device: autoadjusting continuous positive airway pressure

Interventions

autoadjusting continuous positive airway pressure DEVICE

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

Also known as: APAP

In-person management; REVAMP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (3)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161, United States

Location

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033, United States

Location

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

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 33216916 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Limitations and Caveats

The last participant seen/received an intervention on January 31, 2021.

Results Point of Contact

• Title: Samuel T. Kuna, MD
• Organization: Corporal Michael J. Crescenz VA Medical Center

Samuel.Kuna@va.gov

215-823-4400

Study Officials

• Samuel T. Kuna, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2016
• First Posted: January 2, 2017
• Study Start: October 24, 2017
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: May 20, 2025
• Results First Posted: April 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)