Sleep Apnea Syndromes
Conditions
Keywords
Telemedicine, continuous positive airway pressure, treatment adherence
Brief summary
Obstructive sleep apnea (OSA) is highly prevalent in the Veteran population given the risk factors of male gender, being overweight, and increasing age. OSA is caused by upper airway obstruction, resulting in arousals from sleep and hypoxia. While continuous positive airway pressure (CPAP) is a highly efficacious treatment for OSA, compliance with treatment is suboptimal. Because research shows that adherence patterns are established early in treatment, we seek to use a technology that enables early and frequent productive interactions between patient and provider.
Detailed description
Background: Obstructive sleep apnea (OSA) is highly prevalent in the Veteran population given the risk factors of male gender, being overweight, and increasing age. OSA is caused by upper airway obstruction, resulting in arousals from sleep and hypoxia. While continuous positive airway pressure (CPAP) is a highly efficacious treatment for OSA, compliance with treatment is suboptimal. Because research shows that adherence patterns are established early in treatment, we seek to use a technology that enables early and frequent productive interactions between patient and provider Objectives: The objective of this proposal is to explore the feasibility and initially evaluate the potential efficacy of a video teleconferencing system for patients with Obstructive Sleep Apnea syndrome (OSA) that facilitates patient- centered, collaborative management for patients who are prescribed the gold-standard treatment, continuous positive airway pressure (CPAP). Methods: The evaluative aspect of this proposal was designed as a pilot randomized, controlled clinical trial of Video Teleconferencing (VTC) compared to Usual Care (UC). The key feature of the Video Teleconferencing intervention was the use of a telemedicine system that allows for audio/visual conferencing with the patient in their home environment from the start of treatment initialization. The provider is able provide more direct feedback to the patient based on the telemedicine interaction, and the patient benefits from increased contact with the provider. Specific inclusion and exclusion criteria included: age \> 18 years; confirmed diagnosis of moderate-severe OSA; being newly prescribed CPAP therapy; having chronic symptoms as noted on screening symptom checklist; and fluency in English. Patients were recruited from the VA San Diego Healthcare System Pulmonary Sleep Clinic. Patients were enrolled for a 2-month time period. Groups were compared on quantitative and qualitative measures. Status: Study Complete
Interventions
BEHAVIORALVideo Teleconferencing Care
The core component of the VTC intervention is the frequent contact between patient and provider using a telemedicine system that allows for audio-visual communication.
BEHAVIORALUsual Care
Consists of one week telephone call and one month clinic visit
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with Moderate to Severe Sleep Apnea * Live in San Diego County * Veteran
Exclusion criteria
* Previous use of positive pressure airway therapy * Residence outside of San Diego county
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Adherence | 2 months | Nightly CPAP adherence measured over the two-month period . |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Video Teleconferencing Care Video Teleconferencing Care: The core component of the VTC intervention is the frequent contact between patient and provider using a telemedicine system that allows for audio-visual communication. | 13 |
| Usual Care Usual Care: Consists of one week telephone call and one month clinic visit | 10 |
| Total | 23 |
Baseline characteristics
| Characteristic | Video Teleconferencing Care | Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 54.9 years STANDARD_DEVIATION 8.3 | 49.3 years STANDARD_DEVIATION 11.3 | 52.4 years STANDARD_DEVIATION 9.9 |
| Region of Enrollment United States | 13 participants | 10 participants | 23 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 13 Participants | 10 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 13 | 0 / 10 |
| serious Total, serious adverse events | 0 / 13 | 0 / 10 |
Outcome results
Primary
Treatment Adherence
Nightly CPAP adherence measured over the two-month period .
Time frame: 2 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Video Teleconferencing Care | Treatment Adherence | 3.4 hours/night | Standard Deviation 2.4 |
| Usual Care | Treatment Adherence | 3.6 hours/night | Standard Deviation 1.8 |