What this study is
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?
What's being tested
- Couples-based treatment- Patient
Intervention · BEHAVIORAL
- Couples-based treatment- Partner
Intervention · BEHAVIORAL
- Information control- Patient
Intervention · OTHER
- Information control- Partner
Intervention · OTHER
Both Couples-based treatment- Patient and Couples-based treatment- 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
Both Information control- Patient and Information control- Partner
Information only plus treatment as usual
Study details
- 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
- Sponsor
- University of Utah
- Conditions
- Sleep Apnea · Sleep Disturbance
- Enrolling
- 80 people
- Starts
- 2025-03-20
- Est. completion
- 2028-03-01
- Design
- Single-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 35 Years and overSex ALLHealthy volunteers Not acceptedPatients
You may qualify if
- 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.
You can't join if
- 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
Partner
You may qualify if
- 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.
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openBanner Health
Tuscon, Arizona, United States
University of Utah
Salt Lake City, Utah, United States
Study team
Sponsor
University of Utah
Study ID 00177835
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.