Working... Menu

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 : October 10, 2018
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
This study is investigating the effects of a telecommunications system designed to improve patient adherence with prescribed positive airway pressure (CPAP).

Condition or disease Intervention/treatment Phase
Sleep Apnea, Obstructive Device: Telecommunications system Other: TLC-Control Not Applicable

Detailed Description:


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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: RCT of a Telecommunications System in Sleep Apnea
Study Start Date : October 2004
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: TLC-CPAP
A telephone-linked communication (TLC) system for promoting adherence to continuous positive airway pressure (CPAP)
Device: Telecommunications system
The telecommunications system is designed to improve patient adherence with prescribed positive airway pressure.

Placebo Comparator: TLC-Control
A TLC system for providing general health education
Other: TLC-Control
A TLC system for providing general health education

Primary Outcome Measures :
  1. Objective CPAP Use [ Time Frame: 12 months ]
    Mean nightly hours of CPAP use over 12 months

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

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:

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 identifier (NCT number): NCT00232544

Layout table for location information
United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
VA Office of Research and Development
Layout table for investigator information
Principal Investigator: David William Sparrow, DSc VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: VA Office of Research and Development Identifier: NCT00232544     History of Changes
Other Study ID Numbers: IIR 02-230
First Posted: October 4, 2005    Key Record Dates
Results First Posted: February 17, 2014
Last Update Posted: October 10, 2018
Last Verified: September 2018

Keywords provided by VA Office of Research and Development:
sleep apnea, obstructive
Quality of Life
Patient Compliance

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