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
2 other identifiers
interventional
80
1 country
2
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2025
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2024
CompletedFirst Posted
Study publicly available on registry
October 21, 2024
CompletedStudy Start
First participant enrolled
March 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2028
April 2, 2025
March 1, 2025
2.6 years
October 17, 2024
March 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recruitment Feasibility
Defined as the ability to achieve the recruitment goals of the study, to recruit approximately 3-4 couples per month over the study period
36 months
Secondary Outcomes (2)
Proportion of Days With positive airway pressure Use of 4 Hours or More
3 months
Self-reported Sleep Disturbance
3 months
Other Outcomes (2)
Intervention Completion
1 month
Retention
3 months
Study Arms (4)
Couples-based treatment- Patient
EXPERIMENTALIn this group, couples will attend 3-telehealth based sessions with a community health worker for education and interventions to improve communication, sleep quality and PAP use
Couples-based treatment- Partner
EXPERIMENTALIn this group, couples will attend 3-telehealth based sessions with a community health worker for education and interventions to improve communication, sleep quality and PAP use
Information Control- Patient
ACTIVE COMPARATORIn this group, couples will recieve a standardized packet of insomnia about obstructive sleep apnea and starting positive airway pressure.
Information Control- Partner
ACTIVE COMPARATORIn this group, couples will recieve a standardized packet of insomnia about obstructive sleep apnea and starting positive airway pressure.
Interventions
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
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
Information only plus treatment as usual
Information only plus treatment as usual
Eligibility Criteria
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.
- 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 may not qualify 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Utahlead
- National Institute on Aging (NIA)collaborator
- University of Arizonacollaborator
- Banner Healthcollaborator
Study Sites (2)
Banner Health
Tucson, Arizona, 85713, United States
University of Utah
Salt Lake City, Utah, 84108, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 17, 2024
First Posted
October 21, 2024
Study Start
March 20, 2025
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
March 1, 2028
Last Updated
April 2, 2025
Record last verified: 2025-03