Using Telemedicine to Improve Veteran Sleep Apnea Care - Full Text View

Purpose

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	Intervention	Phase
Sleep Apnea Syndromes	Behavioral: Video Teleconferencing Care Behavioral: Usual Care	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Participant) Primary Purpose: Supportive Care
Official Title:	Using Telemedicine to Improve Veteran Sleep Apnea Care

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:

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


Enrollment:	23
Study Start Date:	August 2011
Study Completion Date:	May 2012
Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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


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 )
Study First Received:	December 10, 2010
Results First Received:	February 20, 2015
Last Updated:	October 5, 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

ClinicalTrials.gov processed this record on June 23, 2017