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Using Telemedicine to Improve Veteran Sleep Apnea Care

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ClinicalTrials.gov Identifier: NCT01259440
Recruitment Status : Completed
First Posted : December 14, 2010
Results First Posted : November 4, 2015
Last Update Posted : November 4, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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Brief Summary:
Obstructive sleep apnea (OSA) is highly prevalent in the Veteran population given the risk factors of male gender, being overweight, and increasing age. OSA is caused by upper airway obstruction, resulting in arousals from sleep and hypoxia. While continuous positive airway pressure (CPAP) is a highly efficacious treatment for OSA, compliance with treatment is suboptimal. Because research shows that adherence patterns are established early in treatment, we seek to use a technology that enables early and frequent productive interactions between patient and provider.

Condition or disease Intervention/treatment Phase
Sleep Apnea Syndromes Behavioral: Video Teleconferencing Care Behavioral: Usual Care Phase 1 Phase 2

Detailed Description:

Background:

Obstructive sleep apnea (OSA) is highly prevalent in the Veteran population given the risk factors of male gender, being overweight, and increasing age. OSA is caused by upper airway obstruction, resulting in arousals from sleep and hypoxia. While continuous positive airway pressure (CPAP) is a highly efficacious treatment for OSA, compliance with treatment is suboptimal. Because research shows that adherence patterns are established early in treatment, we seek to use a technology that enables early and frequent productive interactions between patient and provider

Objectives:

The objective of this proposal is to explore the feasibility and initially evaluate the potential efficacy of a video teleconferencing system for patients with Obstructive Sleep Apnea syndrome (OSA) that facilitates patient- centered, collaborative management for patients who are prescribed the gold-standard treatment, continuous positive airway pressure (CPAP).

Methods:

The evaluative aspect of this proposal was designed as a pilot randomized, controlled clinical trial of Video Teleconferencing (VTC) compared to Usual Care (UC). The key feature of the Video Teleconferencing intervention was the use of a telemedicine system that allows for audio/visual conferencing with the patient in their home environment from the start of treatment initialization. The provider is able provide more direct feedback to the patient based on the telemedicine interaction, and the patient benefits from increased contact with the provider. Specific inclusion and exclusion criteria included: age > 18 years; confirmed diagnosis of moderate-severe OSA; being newly prescribed CPAP therapy; having chronic symptoms as noted on screening symptom checklist; and fluency in English. Patients were recruited from the VA San Diego Healthcare System Pulmonary Sleep Clinic. Patients were enrolled for a 2-month time period. Groups were compared on quantitative and qualitative measures.

Status:

Study Complete


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Using Telemedicine to Improve Veteran Sleep Apnea Care
Study Start Date : August 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Video Teleconferencing Care
Video teleconferencing care
 Behavioral: Video Teleconferencing Care
The core component of the VTC intervention is the frequent contact between patient and provider using a telemedicine system that allows for audio-visual communication.
Placebo Comparator: Usual Care
Usual Care
 Behavioral: Usual Care
Consists of one week telephone call and one month clinic visit


Outcome Measures
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Primary Outcome Measures :
  1. Treatment Adherence [ Time Frame: 2 months ]
    Nightly CPAP adherence measured over the two-month period .


Eligibility Criteria
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Information from the National Library of Medicine

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

Inclusion Criteria:

  • Diagnosed with Moderate to Severe Sleep Apnea
  • Live in San Diego County
  • Veteran

Exclusion Criteria:

  • Previous use of positive pressure airway therapy
  • Residence outside of San Diego county
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01259440


Locations
United States, California
VA San Diego Healthcare System
San Diego, California, United States, 92161
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Carl J Stepnowsky, PhD San Diego Veterans Healthcare System
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01259440     History of Changes
Other Study ID Numbers: PPO 10-101
H130392 ( Other Identifier: VA San Diego Healthcare System )
First Posted: December 14, 2010    Key Record Dates
Results First Posted: November 4, 2015
Last Update Posted: November 4, 2015
Last Verified: October 2015

Keywords provided by VA Office of Research and Development:
Telemedicine
continuous positive airway pressure
treatment adherence

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