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OpenTrials
Completed

NCT Number: NCT01259440

Using Telemedicine to Improve Veteran Sleep Apnea Care

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

VA San Diego Healthcare System

San Diego, California, 92161, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Video Teleconferencing Care

Behavioral

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.

Usual Care

Behavioral

Consists of one week telephone call and one month clinic visit

Primary outcomes

  1. Treatment Adherence

    Time frame: 2 months

    Nightly CPAP adherence measured over the two-month period .

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 14, 2010
Registry last updated
Nov 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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