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Nuestro Sueno: Cultural Adaptation of a Couples Intervention to Improve PAP Adherence and Sleep Health Among Latino Couples With Implications for Alzheimer's Disease Risk

NCT06649929

Enrolling By InvitationPhase 2

Sponsor: University of Utah

Conditions: Sleep Apnea, Sleep Disturbance

Interventions: Couples-based treatment- Patient, Couples-based treatment- Partner, Information control- Patient, Information control- Partner

Countries: United States

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?

Eligibility overview

Sex: ALL

Age: 35 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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

Locations (2)

Tuscon, Arizona, United States
Salt Lake City, Utah, United States