Telecommunications System in Sleep Apnea
Primary Purpose
Sleep Apnea, Obstructive
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telecommunications system
TLC-Control
Sponsored by
About this trial
This is an interventional other trial for Sleep Apnea, Obstructive focused on measuring sleep apnea, obstructive, Quality of Life, Depression, Patient Compliance
Eligibility Criteria
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: N/A
Sites / Locations
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
TLC-CPAP
TLC-Control
Arm Description
A telephone-linked communication (TLC) system for promoting adherence to continuous positive airway pressure (CPAP)
A TLC system for providing general health education
Outcomes
Primary Outcome Measures
Objective CPAP Use
Mean nightly hours of CPAP use over 12 months
Secondary Outcome Measures
Daytime Vigilance
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.
Full Information
NCT ID
NCT00232544
First Posted
September 30, 2005
Last Updated
September 10, 2018
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT00232544
Brief Title
Telecommunications System in Sleep Apnea
Official Title
RCT of a Telecommunications System in Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is investigating the effects of a telecommunications system designed to improve patient adherence with prescribed positive airway pressure (CPAP).
Detailed Description
Background/Rationale:
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.
Objective(s):
Use of telecommunications systems with other important health-related behaviors such as medication-taking, diet, and exercise have demonstrated significant improvements in therapy adherence.
Methods:
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.
Status:
Completed
Impact:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
Keywords
sleep apnea, obstructive, Quality of Life, Depression, Patient Compliance
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TLC-CPAP
Arm Type
Experimental
Arm Description
A telephone-linked communication (TLC) system for promoting adherence to continuous positive airway pressure (CPAP)
Arm Title
TLC-Control
Arm Type
Placebo Comparator
Arm Description
A TLC system for providing general health education
Intervention Type
Device
Intervention Name(s)
Telecommunications system
Intervention Description
The telecommunications system is designed to improve patient adherence with prescribed positive airway pressure.
Intervention Type
Other
Intervention Name(s)
TLC-Control
Intervention Description
A TLC system for providing general health education
Primary Outcome Measure Information:
Title
Objective CPAP Use
Description
Mean nightly hours of CPAP use over 12 months
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Daytime Vigilance
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
N/A
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David William Sparrow, DSc
Organizational Affiliation
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20880872
Citation
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.
Results Reference
derived
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Telecommunications System in Sleep Apnea
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