A Phase 2 interventional study of Couples-based treatment- Patient and Couples-based treatment- Partner in Sleep Apnea and Sleep Disturbance, sponsored by University of Utah. Enrolling by invitation at 2 sites in United States. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by University of Utah · Phase 2, Interventional, and Other
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:
Latino adults in the United States are 1.5 times more likely to develop Alzheimer's disease and related dementias compared to non-Hispanic white adults. Obstructive sleep apnea affects 9.8% of Latino adults and confers a five-fold increased risk of Alzheimer's disease diagnosis. Consequences also extend to the bedpartner, as bedpartners of those with obstructive sleep apnea experience significant sleep disturbances, including sleep fragmentation and 3 times greater risk of insomnia. Given solid mechanistic links between both obstructive sleep apnea and insomnia and Alzheimer's Disease risk, effective obstructive sleep apnea treatment has the potential to promote healthy cognitive aging and reduce Alzheimer's Disease risk for both partners. While the front-line treatment for obstructive sleep apnea, positive airway pressure, is highly effective at reducing obstructive sleep apnea symptoms and may reduce or forestall Alzheimer's Disease risk, its potential is severely diminished, as up to 80% of patients are non-adherent. Extant positive airway pressure adherence interventions are limited in that they are exclusively focused on the individual, neglecting to consider the role of the bedpartner in treatment, and developed primarily in non-Hispanic white populations. Therefore, there is a critical need to develop evidence-based, and culturally-adapted interventions that address the impact of obstructive sleep apnea and its treatment on both partners and within a culturally-tailored framework. The goal of this study is to develop and test "Nuestro Sueño" a culturally-adapted intervention to promote positive airway pressure adherence and sleep health among Latino couples. This study will involve a randomized clinical trial to evaluate the feasibility, treatment satisfaction and preliminary efficacy of Nuestro Sueño versus information control in a sample of 80 patients with obstructive sleep apnea and their partners (i.e., 40 couples per treatment arm) across two sites (Utah and Arizona). The intervention focuses specifically on the interpersonal mechanisms of enhancing dyadic coping and communication, using intervention materials resonant with cultural beliefs and values. If successful, Nuestro Sueño, an innovative and culturally-adapted intervention, has the potential to significantly advance the treatment of obstructive sleep apnea, and may elucidate a critical, modifiable target of prevention and intervention to promote healthy aging and reduce disparities in Alzheimer's Disease risk among Latino couples.
2,162 studies on the registry are indexed under Sleep Apnea Syndromes; 290 are open to participants now.
This study's planned enrollment of 80 is above the median of 53 across 1,386 interventional studies indexed under Sleep Apnea Syndromes.
Browse Sleep Apnea Syndromes studies →University of Utah is the lead sponsor of 969 studies on the registry; 178 are open to participants now.
Of its 107 completed or terminated interventional studies of FDA-regulated products, 62 (58%) have results posted.
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Patients inclusion criteria:
Partner inclusion criteria:
Partners of all ethnicities will be invited to participate. The intervention will be delivered in couples preferred language.
Exclusion criteria for both patient and partner
In this group, couples will attend 3-telehealth based sessions with a community health worker for education and interventions to improve communication, sleep quality and PAP use
Behavioral: Couples-based treatment- Patient
In this group, couples will attend 3-telehealth based sessions with a community health worker for education and interventions to improve communication, sleep quality and PAP use
Behavioral: Couples-based treatment- Partner
In this group, couples will recieve a standardized packet of insomnia about obstructive sleep apnea and starting positive airway pressure.
Other: Information control- Patient
In this group, couples will recieve a standardized packet of insomnia about obstructive sleep apnea and starting positive airway pressure.
Other: Information control- Partner
couples 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 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 only plus treatment as usual
Information 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
Time frame: 36 months
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).
Time frame: 3 months
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.
Time frame: 3 months
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
Time frame: 1 month
Retention
We defined retention as the number of participants completing the 3 month follow-up. Our goal was to acheive at least 85% retention.
Time frame: 3 months
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