Telecommunications System in Sleep Apnea
| Status: | Completed |
|---|---|
| Conditions: | Insomnia Sleep Studies, Pulmonary, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/12/2018 |
| Start Date: | October 2004 |
| End Date: | March 2008 |
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).
patient adherence with prescribed positive airway pressure (CPAP).
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.
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.
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:
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