CPAP Training and Education
BehavioralSleep technologists will meet with patients to train them on CPAP use, upkeep, and troubleshooting.
NCT Number: NCT07447284
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.
Trial opening soon.
Get Notified30 year and older
All sexes
Interventional
Not applicable
The MetroHealth System, Cleveland, Ohio, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patient:
Inclusion criteria
- Bed Partner
Exclusion criteria
- Patient:
Sleep technologists will meet with patients to train them on CPAP use, upkeep, and troubleshooting.
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.
Sleep technologists will meet with patients and their bed partners to train them on CPAP use, upkeep, and troubleshooting.
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.
Patients' CPAP adherence will be regularly monitored and automated feedback provided to patient and bed partner when there is change in CPAP use.
Five cognitive behavioral couple therapy sessions will be provided to patients and their bed partners.
Time frame: 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.
Time frame: 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.
Time frame: From enrollment to 30 days, 90 days, 6 months, and 1 year.
Epworth Sleepiness Scale
Time frame: From enrollment to 30 days, 90 days, 6 months, and 1 year.
PROMIS Sleep Disturbance Index
Time frame: From enrollment to 30 days, 90 days, 6 months, and 1 year.
PROMIS Sleep-Related Impairment
Time frame: From enrollment to 30 days, 90 days, 6 months, and 1 year.
Functional Outcomes of Sleep short version
Time frame: 6 months
Actigraphy Data
Time frame: From enrollment to 30 days, 90 days, 6 months, and 1 year.
General quality of life will be assessed using the SF-12
Time frame: From enrollment to 30 days, 90 days, 6 months, and 1 year.
Sleep apnea-related quality of life will be assessed using the Calgary Sleep Apnea Quality of Life Index.
Time frame: From enrollment to 30 days, 90 days, 6 months, and 1 year.
Sleep apnea knowledge will be assessed using the Apnea Beliefs Scale.
Time frame: From enrollment to 30 days, 90 days, 6 months, and 1 year.
Sleep apnea knowledge will be assessed using the Apnea Knowledge Test.
Time frame: 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).
Contact information is provided by the study sponsor or research team.
MetroHealth Medical Center
Other
The Improving Sleep in African American Couples (ISAAC) Study
Acronym: ISAAC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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