Telecommunications System in Sleep Apnea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00232544
Recruitment Status : Completed
First Posted : October 4, 2005
Results First Posted : February 17, 2014
Last Update Posted : April 24, 2015
Information provided by (Responsible Party):
VA Office of Research and Development

September 30, 2005
October 4, 2005
November 4, 2013
February 17, 2014
April 24, 2015
October 2004
March 2008   (Final data collection date for primary outcome measure)
Objective CPAP Use [ Time Frame: 12 months ]
Mean nightly hours of CPAP use over 12 months
Objective CPAP use and disease specific quality of life at 6 and 12 months
Complete list of historical versions of study NCT00232544 on Archive Site
Daytime Vigilance [ Time Frame: 12 months ]
A measure of behavioral alertness. Specifically the metric we used was the mean reaction time, the time it took for a subject to respond to a visual stimulus (light displayed on a screen at random intervals) by hitting a button.
Sleep apnea symptoms, Depression, and daytime vigilance at 6 and 12 months
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Telecommunications System in Sleep Apnea
RCT of a Telecommunications System in Sleep Apnea
This study is investigating the effects of a telecommunications system designed to improve patient adherence with prescribed positive airway pressure (CPAP).


Obstructive sleep apnea syndrome (OSAS) is an important chronic disease of adults, affecting an estimated 4% of men and 2% of women in the United States. Nasal continuous positive airway pressure (CPAP) has been demonstrated to ameliorate the symptoms and neurobehavioral consequences of OSAS. Unfortunately, patient adherence with prescribed CPAP is low, diminishing the benefits obtained from this expensive therapy. Nurse-administered patient education and monitoring of CPAP use through home visits has been shown to be effective in significantly improving CPAP adherence. Given the logistic complexity of delivering this service and its costs, it is unlikely to be disseminated widely into clinical practice. An alternative, using advanced telecommunications technology to deliver similar adherence improvement services, is proposed for study.


Use of telecommunications systems with other important health-related behaviors such as medication-taking, diet, and exercise have demonstrated significant improvements in therapy adherence.


This research project represents a randomized controlled trial of a Telephone-Linked Communications (TLC) system designed to improve CPAP adherence (TLC-CPAP). The study will enroll adults with OSAS who are being started on nasal CPAP therapy. Subjects will be randomized to TLC-CPAP or an attention placebo control group. The effect of TLC on CPAP use and on disease-specific quality of life (QOL), OSAS-related symptoms, depression, and vigilance over a 12-month interval will be assessed.

The intervention and control groups will be compared to assess differences in potential confounders including age, sex, OSAS severity, CPAP pressure level, comorbid illness, physician specialty status, BMI, socioeconomic status, and marital status. Each of the outcome variables (all of which are continuous variables) will be compared between intervention and control groups using multivariate analyses to adjust for any potential confounders that differ between groups. Multivariate models will include appropriate tests of interactions. All analyses will be performed using an intent-to-treat approach.




This Telephone-Linked Communications (TLC) technology offers an effective, low-cost, and easy-to-use means of providing disease-specific education, monitoring, and counseling to improve adherence with therapy.

Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Sleep Apnea, Obstructive
Device: Telecommunications system
The telecommunications system is designed to improve patient adherence with prescribed positive airway pressure.
  • Experimental: TLC-CPAP
    A telephone-linked communication (TLC) system for promoting adherence to continuous positive airway pressure (CPAP)
    Intervention: Device: Telecommunications system
  • Placebo Comparator: TLC-Control
    A TLC system for providing general health education
Sparrow D, Aloia M, Demolles DA, Gottlieb DJ. A telemedicine intervention to improve adherence to continuous positive airway pressure: a randomised controlled trial. Thorax. 2010 Dec;65(12):1061-6. doi: 10.1136/thx.2009.133215. Epub 2010 Sep 29.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2008
March 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Physician diagnosis of obstructive sleep apnea syndrome plus polysomnography demonstrating greater than 10 apneas plus hypopneas per hour of sleep
  • Age 18-80 years
  • Ability to use a telephone without assistance

Exclusion Criteria:

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
IIR 02-230
Not Provided
Not Provided
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: David William Sparrow, DSc VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
VA Office of Research and Development
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP