Protocol for Nuestro Sueño: A randomized trial of a couples-based intervention to improve PAP adherence and sleep health among Hispanic patients beginning positive airway pressure (PAP) and their partners.

BACKGROUND

Obstructive sleep apnea (OSA) is more common among Hispanic individuals and contributes to risk for cardiometabolic diseases, dementia and poor quality of life. Positive airway pressure (PAP) improves sleep and quality of life, and culturally adapted interventions are promising for increasing treatment engagement. The goal of this study is to test Nuestro Sueño, a culturally adapted couples-based intervention to promote positive airway pressure adherence and sleep health for Hispanic couples in which one partner is recently diagnosed with OSA.

METHODS

We are conducting a two-arm, parallel group, single blind, randomized controlled pilot/feasibility trial to compare our novel culturally adapted treatment to an information control (IC). Nuestro Sueño is a culturally adapted dyadic behavioral intervention based on a transdiagnostic model. The digital health program involves 3- weekly sessions delivered via telehealth with a community health worker. Content is focused on education about OSA and PAP, improving both partner's sleep quality, increasing partner support and communication, and couple-level goal-setting around sleep and PAP use. The IC includes standardized patient educational materials. Both groups receive the usual follow-up care. Assessments will be completed pre-treatment, 1 and 3 months after starting PAP. Our main outcomes are feasibility and treatment satisfaction. Secondary outcomes include comparing Nuestro Sueño to IC for PAP adherence, sleep quality (self-report and objective) and cognitive measures of memory, processing speed and verbal fluency.

DISCUSSION: Nuestro Sueño is a novel culturally adapted intervention focused on improving PAP adherence and sleep health among couples in which one partner is recently diagnosed with OSA. Results of this study will be used to inform the design of a subsequent fully adequately-powered clinical trial. If successful, this intervention could significantly advance current clinical practice in the treatment of OSA and sleep health more comprehensively as well as promote sleep health equity among Hispanic patients, who are more likely to face challenges to obtaining diagnosis and treatment for OSA.

TRIAL REGISTRATION: Clinicaltrials.gov, NCT06649929.