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

Part of paid clinical trials in Tuscon, Arizona.

Sponsor
University of Utah
Study ID
NCT06649929
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
35 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Couples-based treatment- Patient — BEHAVIORAL
    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-based treatment- Partner — BEHAVIORAL
    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 control- Patient — OTHER
    Information only plus treatment as usual
  • Information control- Partner — OTHER
    Information only plus treatment as usual

Study Details

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?

Key Dates

Start date
Mar 20, 2025
Status verified
May 2026
Primary completion
Nov 1, 2028
Completion
Dec 1, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Couples-based treatment- Patient
    In 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
  • Experimental: Couples-based treatment- Partner
    In 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
  • Active Comparator: Information Control- Patient
    In this group, couples will recieve a standardized packet of insomnia about obstructive sleep apnea and starting positive airway pressure.
  • Active Comparator: Information Control- Partner
    In this group, couples will recieve a standardized packet of insomnia about obstructive sleep apnea and starting positive airway pressure.

Primary Outcome Measure

Recruitment Feasibility [ Time Frame: 36 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Banner HealthTusconArizona85713
Suzanne Gorovoy
[email protected]
520-874-4208
Michael Grandner
[email protected]
520-874-4208
University of UtahSalt Lake CityUtah84108
Kelly Baron
[email protected]
8015857588

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By research site
Banner Health· Tuscon, AZUniversity of Utah· Salt Lake City, UT

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