Nuestro Sueno: Cultural Adaptation of a Couples Intervention to Improve PAP Adherence and Sleep H… (NCT06649929) | Clinical Trial Compass
RecruitingPhase 2
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
United States80 participantsStarted 2025-03-20
Plain-language 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?
Who can participate
Age range
35 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 participat…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.