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Remote Sleep Apnea Management

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ClinicalTrials.gov Identifier: NCT03007745
Recruitment Status : Recruiting
First Posted : January 2, 2017
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Sleep Apnea - Obstructive Cost Effectiveness Telemedicine Device: autoadjusting continuous positive airway pressure Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 356 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Remote Ambulatory Management of Veterans With Sleep Apnea
Actual Study Start Date : October 24, 2017
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: 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.
Device: 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
Other Name: APAP

Active Comparator: In-person management
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
Participants in both arms who are diagnosed with obstructive sleep apnea will be treated with autoadjusting continuous positive airway pressure
Other Name: APAP




Primary Outcome Measures :
  1. Functional Outcome of Sleep Questionnaire - Short Form (FOSQ-10) [ Time Frame: 3 months ]
    Self-administered disease specific quality of life questionnaire


Secondary Outcome Measures :
  1. Epworth Sleepiness Scale (ESS) [ Time Frame: 3 months ]
    Self-administered subjective measure of daytime sleepiness

  2. Heath Survey Short Form - 12 (SF-12) [ Time Frame: 3 months ]
    Self administered quality of life questionnaire

  3. Center for Epidemiological Studies Depression questionnaire (CES-D) [ Time Frame: 3 months ]
    Self-administered assessment of depression

  4. Insomnia Severity Index (ISI) [ Time Frame: 3 months ]
    Self-administered assessment of insomnia

  5. Health Utilities Index (HUI) [ Time Frame: 3 months to 2.5 years ]
    Self-administered questionnaire on overall functional health

  6. EuroQol [ Time Frame: 3 months to 2.5 years ]
    Self-administered questionnaire on quality of life

  7. Worker Alliance Inventory - Short Revised (WAI-SR) [ Time Frame: 3 months ]
    Assessment of patient-rated alliance with the practitioner

  8. Client Satisfaction Questionnaire (CSQ-8) [ Time Frame: 3 months ]
    Self-administered questionnaire assessing patient satisfaction with care delivered

  9. Adherence to autoadjusting CPAP treatment [ Time Frame: 3 months ]
    Objective assessment of treatment adherence and efficacy



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Veterans must meet the following inclusion criteria prior to enrollment:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03007745


Contacts
Contact: Samuel T Kuna, MD (215) 823-5800 ext 4400 samuel.kuna@va.gov
Contact: Lakshmi P Villa, BS (215) 823-5800 Lakshmi.Villa@va.gov

Locations
United States, California
VA San Diego Healthcare System, San Diego, CA Recruiting
San Diego, California, United States, 92161
Contact: Carl J Stepnowsky, Jr., PhD    858-642-1240    Carl.Stepnowsky@va.gov   
Sub-Investigator: Carl J Stepnowsky, Jr., PhD         
United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA Recruiting
Decatur, Georgia, United States, 30033
Contact: Barry G Fields       Barry.Fields@va.gov   
Sub-Investigator: Barry G. Fields         
United States, Pennsylvania
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Samuel T Kuna, MD    215-823-5800 ext 4400    samuel.kuna@va.gov   
Principal Investigator: Samuel T. Kuna, MD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Samuel T. Kuna, MD Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03007745     History of Changes
Other Study ID Numbers: IIR 12-409
First Posted: January 2, 2017    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
Continuous positive airway pressure

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases