The goal of this clinical trial is to learn if the culturally adapted couples sleep health intervention (Nuestro Sueno) improves positive airway pressure use and sleep among Hispanic couples in which one partner was diagnosed with sleep apnea and starting positive airway pressure treatment.
The main questions are:
1. Does Nuestro sueno improve the patient's positive airway pressure use over the first 3 months of using it compared to an information control? 2. Does Nuestro sueno improve sleep quality for both the patient and partner, compared to an information control? 3. Does Nuestro sueno improve other aspects of life including quality of life and memory, compared to an information control?
Self-reported Latino ethnicity
Age >35, 3)
Diagnosed with obstructive sleep apnea and intend to start PAP
Never used positive airway pressure or-restarting CPAP after 3 months
High risk or presence of moderate to severe comorbid sleep disorders (i.e., restless legs syndrome)
History of cognitive or neurological or major psychiatric disorders
Unstable or serious medical illness that would interfere with participation (cancer, renal disease on dialysis, moderate to severe chronic obstructive pulmonary disease
Patients with need for more complex care (e.g., adaptive servo-ventilation, supplemental oxygen) or concurrent sleep apnea treatment such as bariatric surgery or oral appliance
Parallel
Couples-based treatment- Patient
Behavioralcouples will attend 3-telehealth based sessions to provide eduction, increase self-efficacy and teach skils based in principles of brief behavioral therapy for insomnia
Couples-based treatment- Partner
Behavioralcouples will attend 3-telehealth based sessions to provide eduction, increase self-efficacy and teach skils based in principles of brief behavioral therapy for insomnia
Information control- Patient
Other interventionInformation only plus treatment as usual
Information control- Partner
Other interventionInformation only plus treatment as usual
Recruitment Feasibility
Defined as the ability to achieve the recruitment goals of the study, to recruit approximately 3-4 couples per month over the study period
Proportion of Days With positive airway pressure Use of 4 Hours or More
The primary efficacy measure for this pilot trial was the proportion of days that patients used CPAP for 4 hours or more over the first 3 months. This 4 hour cutoff was selected becasue it is the minimum usage defined by Medicare and other insurance companies. We obtained patients' CPAP usage by downloading data from their machine using a remote dashboard. Data are only available for patients because partners were not using the treatment. This variable is defined as a proportion, calculated as the number of days with CPAP usage of 4 hours or more divided by the total number of days collected in the 3 month recording period. Scores can range from 0 (no days with use to 1, indicating all days with use of 4 hours or more).
Self-reported Sleep Disturbance
Patient sleep quality on the Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance scale, 8 item, version 8b. Models evaluated change from baseline to 3 months. Raw are converted to t-scores, with a range of 28.9-76.5, a mean of 50 and a SD of 10. Higher scores indicate poorer sleep subjective quality.
Intervention Completion
Percentage of participants who completed the intervention sessions: 3 sessions for the couples-based treatment group and 1 handout and phone call for the information control group
Retention
We defined retention as the number of participants completing the 3 month follow-up. Our goal was to acheive at least 85% retention.
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University of Utah
Lead sponsor
National Institute on Aging (NIA)
Collaborator
University of Arizona
Collaborator
Banner Health
Collaborator
