Sleep Apnea, Obstructive
Conditions
Keywords
sleep apnea, obstructive, Quality of Life, Depression, Patient Compliance
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.
Interventions
The telecommunications system is designed to improve patient adherence with prescribed positive airway pressure.
OTHERTLC-Control
A TLC system for providing general health education
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
N/A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective CPAP Use | 12 months | Mean nightly hours of CPAP use over 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daytime Vigilance | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TLC-CPAP A telephone-linked communication (TLC) system for promoting adherence to continuous positive airway pressure (CPAP) | 124 |
| TLC-Control A TLC system for providing general health education | 126 |
| Total | 250 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 20 | 15 |
Baseline characteristics
| Characteristic | TLC-CPAP | TLC-Control | Total |
|---|---|---|---|
| Age, Continuous | 56 years | 54 years | 55 years |
| Region of Enrollment United States | 124 participants | 126 participants | 250 participants |
| Sex: Female, Male Female | 24 Participants | 21 Participants | 45 Participants |
| Sex: Female, Male Male | 100 Participants | 105 Participants | 205 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 124 | 0 / 126 |
| serious Total, serious adverse events | 1 / 124 | 0 / 126 |
Outcome results
Primary
Objective CPAP Use
Mean nightly hours of CPAP use over 12 months
Time frame: 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| TLC-CPAP | Objective CPAP Use | 0.437 log(hours/night) |
| TLC-Control | Objective CPAP Use | -0.066 log(hours/night) |
Secondary
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| TLC-CPAP | Daytime Vigilance | 293.7 ms |
| TLC-Control | Daytime Vigilance | 324.0 ms |