Culturally adapted couples intervention to improve sleep health and PAP adherence among Latino couples
Nuestro Sueno: Cultural Adaptation of a Couples Intervention to Improve Positive Airway Pressure Adherence and Sleep Health Among Latino Couples With Implications for Alzheimer's Disease Risk
This study is testing a special program for Latino couples to see if it helps them stick to their sleep apnea treatment and improve their sleep quality.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 35 Years and up |
| Sex | All |
| Sponsor | University of Utah Academic / other |
| Locations | 2 sites (Tucson, Arizona and 1 other locations) |
| Trial ID | NCT06649929 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a culturally adapted couples intervention, Nuestro Sueno, in improving adherence to positive airway pressure (PAP) therapy and sleep quality among Latino couples where one partner has been diagnosed with obstructive sleep apnea. The study will compare outcomes between couples receiving the intervention and those receiving standard information control over a three-month period. Key outcomes include PAP usage, sleep quality for both partners, and overall quality of life and memory. The intervention is designed to address the unique cultural needs of Latino couples, recognizing the significant impact of sleep apnea on both partners' health.
Who should consider this trial
Good fit: Ideal candidates include Latino adults over 35 diagnosed with obstructive sleep apnea who are starting PAP treatment and have a romantic partner willing to participate.
Not a fit: Patients with moderate to severe comorbid sleep disorders or significant cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance PAP adherence and improve sleep health, potentially reducing Alzheimer's disease risk for both partners.
How similar studies have performed: While there is limited research specifically on culturally adapted interventions for Latino couples, existing studies on PAP adherence interventions have shown promise, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Patients inclusion criteria: * 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 * Married or cohabiting with a romantic partner for \>1 year * Able to read/write English or Spanish * Access to cellular (active data plan) or Wi-Fi, or able to use study devices in order to complete the telehealth intervention. Partner inclusion criteria: * Able to read/write in English or Spanish * Interested in improving their sleep (yes/no) * Access to cellular (active data plan) or Wi-Fi, to complete the telehealth intervention or able to use a study device. 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 * 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 * Overnight work \> 1x per month; 7) Pregnancy/desire to become pregnant in the study period; 8) Current participation in behavioral sleep treatment (e.g., cognitive behavioral therapy for insomnia) * Concurrent participation in another clinical trial * Caregiving for an infant \< 2 years old or adult who requires overnight assistance
Where this trial is running
Tucson, Arizona and 1 other locations
- Banner Health — Tucson, Arizona, United States (Not_yet_recruiting)
- University of Utah — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Study coordinator: Sofia Vallejo
- Email: Sofia.vallejo@hsc.utah.edu
- Phone: 801-213-2512
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.