Obstructive Sleep Apnea
Conditions
Keywords
Wearable, Pulse oximetry, Sleep apnea, Treatment adherence
Brief summary
The goal of this clinical trial in adults with obstructive sleep apnea prescribed positive airway pressure therapy is to test the effects of a new patient-facing consumer wearable-based program (that involves provision of a consumer wearable that measures oxygen levels during sleep plus customized weekly reports to participants). The main question is to learn whether participants' use of positive airway pressure therapy will differ between the participants who receive the new program immediately versus delayed. Participants assigned to the delayed program will receive usual care while waiting for the program to begin.
Detailed description
After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening to determine eligibility for study entry. Patients who meet the eligibility requirements will be randomized to immediate versus waitlist control in a 1:1 ratio. Our project is at the forefront of consumer wearable research, leveraging the recent capabilities of consumer wearables to provide pulse oximetry data during sleep, to uncover new ways to promote PAP usage among patients with obstructive sleep apnea.
Interventions
BEHAVIORALImmediate Intervention
Participants will receive customized weekly reports from the pulse oximetry data collected by the consumer wearable.
BEHAVIORALWaitlist control
Participants only receive usual care from the sleep center.
Sponsors
VA Greater Los Angeles Healthcare System
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Prescribed PAP therapy from the sleep center for \> 1 week * Have an active profile in our Center's ResMed AirView or Respironics Care Orchestrator accounts for \> 1 week * Non-adherent with PAP therapy * Willing to continue using current PAP device for 28 days continuously * Have an electronic device compatible with the wearable app
Exclusion criteria
* Diagnosis of heart failure, chronic lung disease, dementia, active substance use disorder * Use home oxygen * Unstable medical or psychiatric illness * Planned non-use of PAP therapy (e.g., waiting for replacement of recalled PAP device) * Planned surgery or hospitalization during study period * Planned extensive travel during study period * History of repeated non-attendance at clinic visits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in PAP Adherence (Minutes) From Baseline to Post-treatment (T3) | 5 weeks | Change in mean minutes of PAP use per night between baseline (T1) and post-treatment (T3), which was 35 days after randomization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in PAP Adherence (Days Used >= 4 Hours) From Baseline to Post-treatment (T3) | 5 weeks | Change in the days PAP was used \>= 4 hours from baseline (T1) to post-treatment (T3), which occurred 35 days after randomization. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORConstance H. Fung, MD, MSHS
VA Greater Los Angeles Healthcare System
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 45.4 years STANDARD_DEVIATION 9.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 4 / 25 | 5 / 25 |
| serious Total, serious adverse events | 1 / 25 | 0 / 25 |
Outcome results
None listed