Clinical trial NCT06649929: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Sleep Apnea
Sleep Disturbance
Keywords: sleep
couples
positive airway pressure
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: University of Arizona
name: Banner Health
First posted: 2024-10-21
Enrollment: 80
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Couples will be randomized 1:1 to intervention and control
Primary purpose: OTHER

Brief summary: 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?

Detailed description: 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.

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

Primary outcomes:
measure: Recruitment Feasibility
timeFrame: 36 months
Secondary outcomes:
measure: Proportion of Days With positive airway pressure Use of 4 Hours or More
timeFrame: 3 months
measure: Self-reported Sleep Disturbance
timeFrame: 3 months
Other outcomes:
measure: Intervention Completion
timeFrame: 1 month
measure: Retention
timeFrame: 3 months
Locations:
city: Tucson
country: United States
facility: Banner Health
state: Arizona
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References: