Obstructive Sleep Apnea (OSA)
Conditions
Keywords
Sleep Apnea Syndromes/Therapy, Continuous Positive Airway Pressure, Couples Therapy
Brief summary
The goal of this randomized study is to compare a combined behavioral intervention (remote tele-monitoring and feedback, virtual cognitive behavioral couple therapy, and couple-oriented peer support) on continuous positive airway pressure (CPAP) adherence, quality of sleep, functional status, and quality of life among patients with obstructive sleep apnea (OSA) and their bed partners.
Detailed description
This is a multiple site randomized controlled trial of 220 African American patients diagnosed with moderate to severe OSA and their bed partners. Half of the patients will receive optimal usual care, consisting of sleep therapist-initiated CPAP education and training. Patients will follow up with their sleep providers per usual. The remaining patients and their bed partners will receive a couple-oriented intervention consisting of optimal usual care. Couples will participate in couple-oriented support groups led by an African American patient with long standing OSA treated with CPAP and their partner. Patients and partners will receive tailored text messages encouraging adherence. In addition, couples will receive cognitive behavioral couple therapy sessions with a health psychologist trained in behavioral sleep medicine.
Interventions
BEHAVIORALCPAP Training and Education
Sleep technologists will meet with patients to train them on CPAP use, upkeep, and troubleshooting.
BEHAVIORALVirtual Disease Support Group Sessions
Patients will attend 3 virtual webinars on prevention and management of diseases affecting the Black community including hypertension, obesity, cardiovascular disease, and cancer led by African American providers.
BEHAVIORALCouple CPAP Training and Education
Sleep technologists will meet with patients and their bed partners to train them on CPAP use, upkeep, and troubleshooting.
BEHAVIORALCouples Virtual OSA Support Group Sessions
Patient and their bed partner will participate in 3 virtual group sessions moderated by an African American patient with longstanding OSA who regularly uses CPAP and their bed partner.
BEHAVIORALCPAP Tele-monitoring and Feedback
Patients' CPAP adherence will be regularly monitored and automated feedback provided to patient and bed partner when there is change in CPAP use.
BEHAVIORALCouples' Cognitive Behavioral Therapy
Five cognitive behavioral couple therapy sessions will be provided to patients and their bed partners.
Sponsors
MetroHealth Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
University of Pittsburgh
MetroHealth System, Ohio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
CPAP telemonitoring and feedback Behavioral couple therapy Couple peer motivators
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Patient: * Moderate or severe OSA (Apnea hypopnea index ≥ 15 events/hour) * Age ≥ 30 years * Bed partner for ≥ last 6 months who is willing to participate * English proficient Inclusion Criteria - Bed Partner * Bed partner for ≥ 6 months and willing to participate * English proficient
Exclusion criteria
- Patient: * Terminal illness * Neurocognitive disorder that prevents informed consent * Unstable housing * Need for other forms of positive airway pressure (BPAP or VPAP) * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Nightly CPAP Use at 1 Year | From enrollment until 1 year. | Mean CPAP use at year will be the total hours of CPAP use divided by the number of days observed for the patient over the course of a year. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-efficacy to Use CPAP | From enrollment to 30 days, 90 days, 6 months, and 1 year. | Self-efficacy to use CPAP will be assessed using the Self-Efficacy Measure in Sleep Apnea (SEMSA). |
| Sleep Apnea Beliefs | From enrollment to 30 days, 90 days, 6 months, and 1 year. | Sleep apnea knowledge will be assessed using the Apnea Beliefs Scale. |
| Mean Nightly CPAP Use | From enrollment to 30 days, 90 days, and 6 months. | Mean CPAP use will be the total hours of CPAP use divided by the number of days observed for the patient over the course of the designated time interval. |
| Patient and Bed Partner Quality of Sleep | From enrollment to 30 days, 90 days, 6 months, and 1 year. | Epworth Sleepiness Scale |
| Patient-Reported Measure of OSA Treatment | From enrollment to 30 days, 90 days, 6 months, and 1 year | Patient-Reported Longitudinal Assessment Tool for OSA (PLATO-11) |
| Sleep Apnea Knowledge | From enrollment to 30 days, 90 days, 6 months, and 1 year. | Sleep apnea knowledge will be assessed using the Apnea Knowledge Test. |
| Patient and Bed Partner Quality of Life | From enrollment to 30 days, 90 days, 6 months, and 1 year. | General quality of life will be assessed using the SF-12 |
Countries
United States
Contacts
CONTACTMarquisha Marbury
PRINCIPAL_INVESTIGATORJohn Thornton, MD, MPH
MetroHealth System, Ohio
Outcome results
None listed